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Not enough enrollment due to the COVID19 pandemic.
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| Name | Class |
|---|---|
| University of Pittsburgh Medical Center | OTHER |
| Berry Consultants | OTHER |
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The purpose of this project is to determine the effect of various interventions to improve patient outcome as defined by hospital free days at day 90 for adult patients undergoing elective surgery. Within this project, multiple studies may be conducted.
The structure of this project permits:
The first study to be conducted under this project (IRB STUDY19090186) is the Strategies to Promote ResiliencY (SPRY) clinical trial (IRB PRO18060038).
The SPRY clinical trial will determine the effectiveness of Metformin on improving surgical outcomes among nondiabetic older adults who are scheduled for elective surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPRY: Metformin LD-SC (low-dose, short course) | Experimental | LD-SC (low-dose, short course) Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. |
|
| SPRY: Metformin LD-IC (low-dose, intermediate course) | Experimental | LD-IC (low-dose, intermediate course) Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. |
|
| SPRY: Metformin LD-LC (low-dose, long course) | Experimental | LD-LC (low-dose, long course) Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. |
|
| SPRY: Metformin ID-SC (intermediate-dose, short course) | Experimental | ID-SC (intermediate-dose, short course) Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin ER | Drug | tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Free Days (HFD) | 90 - the number of days during the index stay minus the number of days readmitted during the 90 days after surgery. Death within 90 days after surgery is recorded as -1 HFD. | Day 90 from the date of the elective surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ICU Admission After Surgery | The intended measure of this outcome is to get the rate of ICU admission per described group or the number of participants that had an ICU admission within each group. | Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days in the event ICU admission is needed |
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UPMC REMAP
Inclusion Criteria:
Exclusion Criteria:
SPRY Domain
Inclusion Criteria:
Exclusion Criteria:
The treating clinician believes that participation in the domain would not be in the best interest of the patient
Pre-existing diabetes type I or II
Women of child-bearing potential
Hospital stay <24 hours
Presently taking metformin or prior use in the past 6 months
Evidence of an absolute or relative contraindication to Metformin therapy
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| Name | Affiliation | Role |
|---|---|---|
| Matthew D Neal, MD, FACS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32994242 | Derived | Reitz KM, Seymour CW, Vates J, Quintana M, Viele K, Detry M, Morowitz M, Morris A, Methe B, Kennedy J, Zuckerbraun B, Girard TD, Marroquin OC, Esper S, Holder-Murray J, Newman AB, Berry S, Angus DC, Neal M. Strategies to Promote ResiliencY (SPRY): a randomised embedded multifactorial adaptative platform (REMAP) clinical trial protocol to study interventions to improve recovery after surgery in high-risk patients. BMJ Open. 2020 Sep 29;10(9):e037690. doi: 10.1136/bmjopen-2020-037690. |
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De-identified participant-level data underlying the results reported in journal articles, subject to appropriate security controls, may be available for sharing with other researchers.
Relevant data may be available 1 year following publication
Data access is subject to a methodologically sound proposal and the necessary data sharing agreements.
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| ID | Title | Description |
|---|---|---|
| FG000 | SPRY: Metformin LD-SC (Low-dose, Short Course) | LD-SC (low-dose, short course) Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| FG001 | SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | LD-IC (low-dose, intermediate course) Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| FG002 | SPRY: Metformin LD-LC (Low-dose, Long Course) | LD-LC (low-dose, long course) Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| FG003 | SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | ID-SC (intermediate-dose, short course) Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| FG004 | SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | ID-IC (intermediate-dose, intermediate course) Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| FG005 | SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | ID-LC (intermediate-dose, long course) Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| FG006 | SPRY: Metformin HD-SC (High-dose, Short Course) | HD-SC (high-dose, short course) After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| FG007 | SPRY: Metformin HD-IC (High-dose, Intermediate Course) | HD-IC (high-dose, intermediate course) After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| FG008 | SPRY: Metformin HD-LC (High-dose, Long Course) | HD-LC (high-dose, long course) After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| FG009 | SPRY: Placebo | Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course. Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
None of the participants were randomized to the high-dose long course combination of drug dose and preoperative duration.
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| ID | Title | Description |
|---|---|---|
| BG000 | SPRY: Metformin LD-SC (Low-dose, Short Course) | LD-SC (low-dose, short course) Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hospital Free Days (HFD) | 90 - the number of days during the index stay minus the number of days readmitted during the 90 days after surgery. Death within 90 days after surgery is recorded as -1 HFD. | Participants were analyzed using intention-to-treat analysis. Participants that did not undergo an operation were excluded. | Posted | Median | Inter-Quartile Range | Days | Day 90 from the date of the elective surgical procedure |
|
From the time the participant is prescribed the study drug until 90 days after surgery.
There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation.
The numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SPRY: Metformin LD-SC (Low-dose, Short Course) | LD-SC (low-dose, short course) Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| From time of prescription until 90 days after surgery | Cardiac disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Time of prescription of study drug until 90 days after surgery | Gastrointestinal disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
Recruitment was terminated early and was limited by the COVID-19 pandemic, as such the study is underpowered and could not meet its set goals. No patients fell in the high dose long course group since no participants were randomized to that group
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew D. Neal, MD FACS | UPMC | 412-647-1158 | nealm2@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 17, 2020 | Mar 6, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 6, 2023 | Mar 5, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 22, 2021 | Mar 5, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
| SPRY: Metformin ID-IC (intermediate-dose, intermediate course) | Experimental | ID-IC (intermediate-dose, intermediate course) Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. |
|
| SPRY: Metformin ID-LC (intermediate-dose, long course) | Experimental | ID-LC (intermediate-dose, long course) Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. |
|
| SPRY: Metformin HD-SC (high-dose, short course) | Experimental | HD-SC (high-dose, short course) After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. |
|
| SPRY: Metformin HD-IC (high-dose, intermediate course) | Experimental | HD-IC (high-dose, intermediate course) After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. |
|
| SPRY: Metformin HD-LC (high-dose, long course) | Experimental | HD-LC (high-dose, long course) After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. |
|
| SPRY: Placebo | Placebo Comparator | Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course. |
|
|
| Placebo | Drug | Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms. |
|
| Incidence and Total Number of Reoperation/Reintervention | This outcome is also intended to measure the rate of Reoperation/reintervention within each group or the total number of participants that had a Reoperation/reintervention within each group as shown below | Day 90 from the date of the elective surgical procedure |
| Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism | The intended measure from this outcome is to also show the rate of Venous thromboembolic events or the number of participants with Venous thromboembolic events within each group | Day 90 from the date of the elective surgical procedure |
| Number of Participants With Surgical Site Infection | Day 30 from the date of the elective surgical procedure |
| Number of Participants With Surgical Site Occurrence | Day 30 from the date of the elective surgical procedure |
| Organ Failure Free Days | Day 30 from the date of the elective surgical procedure |
| Hospital Length of Stay (LOS) | Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days |
| ICU (Intensive Care Unit) Length of Stay (LOS) | Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is needed |
| Mortality | Day 90 from the date of the elective surgical procedure |
| Hospital Readmission Rate | Day 90 from the date of the elective surgical procedure |
| Gastrointestinal Intolerance | From enrollment to day 90 after surgery |
| SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | The number of participants here includes the full cohort because adverse events were recorded for all participants while other outcome measures were only recorded for participants that underwent surgery | From enrollment to day 90 after surgery |
| Discharge Disposition | Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is needed |
| In Hospital Mortality | Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is needed. |
| BG001 |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) |
LD-IC (low-dose, intermediate course) Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| BG002 | SPRY: Metformin LD-LC (Low-dose, Long Course) | LD-LC (low-dose, long course) Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| BG003 | SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | ID-SC (intermediate-dose, short course) Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| BG004 | SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | ID-IC (intermediate-dose, intermediate course) Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| BG005 | SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | ID-LC (intermediate-dose, long course) Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| BG006 | SPRY: Metformin HD-SC (High-dose, Short Course) | HD-SC (high-dose, short course) After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| BG007 | SPRY: Metformin HD-IC (High-dose, Intermediate Course) | HD-IC (high-dose, intermediate course) After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| BG008 | SPRY: Metformin HD-LC (High-dose, Long Course) | HD-LC (high-dose, long course) After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| BG009 | SPRY: Placebo | Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course. Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms. |
| BG010 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Risk analysis index score | This is a measure of frailty. Score is prospectively calculated during the preoperative visit and is a score that ranges from 0-81. A higher score represents increased frailty and higher susceptibility to postoperative complications. | Mean | Standard Deviation | units on a scale |
|
| Smoking status | Count of Participants | Participants |
|
| History of Stroke | Count of Participants | Participants |
|
| History of chronic obstructive pulmonary disease | Count of Participants | Participants |
|
| History of coronary artery disease | Count of Participants | Participants |
|
| History of congestive heart failure | Count of Participants | Participants |
|
| Surgical strata | Count of Participants | Participants |
|
| OG001 |
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) |
LD-IC (low-dose, intermediate course) Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| OG002 | SPRY: Metformin LD-LC (Low-dose, Long Course) | LD-LC (low-dose, long course) Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| OG003 | SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | ID-SC (intermediate-dose, short course) Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| OG004 | SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | ID-IC (intermediate-dose, intermediate course) Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| OG005 | SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | ID-LC (intermediate-dose, long course) Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| OG006 | SPRY: Metformin HD-SC (High-dose, Short Course) | HD-SC (high-dose, short course) After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| OG007 | SPRY: Metformin HD-IC (High-dose, Intermediate Course) | HD-IC (high-dose, intermediate course) After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| OG008 | SPRY: Metformin HD-LC (High-dose, Long Course) | HD-LC (high-dose, long course) After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet |
| OG009 | SPRY: Placebo | Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course. Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms. |
|
|
|
| Secondary | Incidence of ICU Admission After Surgery | The intended measure of this outcome is to get the rate of ICU admission per described group or the number of participants that had an ICU admission within each group. | Participants analyzed using intention-to-treat analysis. Participants that did not undergo surgery were excluded | Posted | Count of Participants | Participants | Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days in the event ICU admission is needed |
|
|
|
|
| Secondary | Incidence and Total Number of Reoperation/Reintervention | This outcome is also intended to measure the rate of Reoperation/reintervention within each group or the total number of participants that had a Reoperation/reintervention within each group as shown below | Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded | Posted | Count of Participants | Participants | Day 90 from the date of the elective surgical procedure |
|
|
|
|
| Secondary | Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism | The intended measure from this outcome is to also show the rate of Venous thromboembolic events or the number of participants with Venous thromboembolic events within each group | Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded | Posted | Count of Participants | Participants | Day 90 from the date of the elective surgical procedure |
|
|
|
|
| Secondary | Number of Participants With Surgical Site Infection | Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded | Posted | Count of Participants | Participants | Day 30 from the date of the elective surgical procedure |
|
|
|
|
| Secondary | Number of Participants With Surgical Site Occurrence | Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded | Posted | Count of Participants | Participants | Day 30 from the date of the elective surgical procedure |
|
|
|
|
| Secondary | Organ Failure Free Days | Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded | Posted | Mean | Standard Error | Days | Day 30 from the date of the elective surgical procedure |
|
|
|
|
| Secondary | Hospital Length of Stay (LOS) | Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded | Posted | Mean | Standard Deviation | Days | Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days |
|
|
|
|
| Secondary | ICU (Intensive Care Unit) Length of Stay (LOS) | Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded | Posted | Mean | Standard Deviation | Days | Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is needed |
|
|
|
|
| Secondary | Mortality | Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded. Only one mortality was observed and thus no statistical analysis was performed | Posted | Count of Participants | Participants | Day 90 from the date of the elective surgical procedure |
|
|
|
| Secondary | Hospital Readmission Rate | Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded | Posted | Count of Participants | Participants | Day 90 from the date of the elective surgical procedure |
|
|
|
|
| Secondary | Gastrointestinal Intolerance | All participants included. Group with zero participants added for completion | Posted | Count of Participants | Participants | From enrollment to day 90 after surgery |
|
|
|
|
| Secondary | SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated) | The number of participants here includes the full cohort because adverse events were recorded for all participants while other outcome measures were only recorded for participants that underwent surgery | All participants included. Group with zero participants included for completion | Posted | Count of Participants | Participants | From enrollment to day 90 after surgery |
|
|
|
|
| Secondary | Discharge Disposition | Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded | Posted | Count of Participants | Participants | Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is needed |
|
|
|
|
| Secondary | In Hospital Mortality | Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded. No in-hospital mortalities were observed and hence no statistical analysis was performed | Posted | Count of Participants | Participants | Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is needed. |
|
|
|
| 0 |
| 39 |
| 11 |
| 39 |
| 10 |
| 39 |
| EG001 | SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | LD-IC (low-dose, intermediate course) Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet | 0 | 20 | 5 | 20 | 5 | 20 |
| EG002 | SPRY: Metformin LD-LC (Low-dose, Long Course) | LD-LC (low-dose, long course) Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet | 0 | 5 | 2 | 5 | 2 | 5 |
| EG003 | SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | ID-SC (intermediate-dose, short course) Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet | 1 | 39 | 10 | 39 | 9 | 39 |
| EG004 | SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | ID-IC (intermediate-dose, intermediate course) Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet | 0 | 19 | 6 | 19 | 5 | 19 |
| EG005 | SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | ID-LC (intermediate-dose, long course) Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet | 0 | 8 | 2 | 8 | 2 | 8 |
| EG006 | SPRY: Metformin HD-SC (High-dose, Short Course) | HD-SC (high-dose, short course) After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet | 0 | 40 | 12 | 40 | 11 | 40 |
| EG007 | SPRY: Metformin HD-IC (High-dose, Intermediate Course) | HD-IC (high-dose, intermediate course) After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet | 0 | 26 | 4 | 26 | 3 | 26 |
| EG008 | SPRY: Metformin HD-LC (High-dose, Long Course) | HD-LC (high-dose, long course) After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure. Metformin ER: tablet | 0 | 0 | 0 | 0 | 0 | 0 |
| EG009 | SPRY: Placebo | Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course. Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms. | 0 | 106 | 12 | 106 | 10 | 106 |
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| Time of prescription until 90 days after surgery | Hepatobiliary disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Immune system disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | General disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Nervous system disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Blood and lymphatic system disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Gastrointestinal disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Infections and infestations | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Metabolism and nutrition disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Renal and urinary disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Vascular disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription of study drug until 90 days after surgery | Blood and lymphatic system disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Cardiac disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | General disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Hepatobiliary disorders | Systematic Assessment |
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| Time of prescription until 90 days after surgery | Infections and infestations | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Injury, poisoning and procedural complications | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Investigations | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Metabolism and nutrition disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription until 90 days after surgery | Nervous system disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription of study drug until 90 days after surgery | Psychiatric disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription of study drug until 90 days after surgery | Renal and urinary disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription of study drug until 90 days after surgery | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription of study drug until 90 days after surgery | Skin and subcutaneous tissue disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription of study drug until 90 days after surgery | Surgical and medical procedures | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Time of prescription of study drug until 90 days after surgery | Vascular disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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Not provided
Not provided
Not provided
| Mild- possibly related |
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| Mild - unrelated |
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| Moderate - related |
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| Moderate- possibly related |
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| Moderate - unrelated |
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| Severe - related |
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| Severe- possibly related |
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| Severe - unrelated |
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| life threatening/disabling - related |
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| life threatening/disabling - possibly related |
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| life threatening/disabling - unrelated |
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| Skilled nursing facility/Rehabilitation facility |
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| Death/Hospice |
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| Missing data |
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