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| ID | Type | Description | Link |
|---|---|---|---|
| P50GM111152-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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This study investigates the mechanism by which kidney dysfunction perpetuates inflammation, immunosuppression, and catabolism (PICS) in chronic critical illness. The investigators will test the hypothesis that persistent kidney dysfunction in sepsis associated by chronic critical illness contributes to decreased survival through the development of PICS. In chronic critical illness, the persistence of the inflammatory state may lead to capillary rarefication in the kidney causing accelerated chronic kidney disease. Progression of chronic kidney disease during chronic critical illness can drive PICS. Indeed, many of the features of chronic critical illness are consistent with the protein-energy malnutrition and muscle wasting associated with chronic kidney disease. Thus, the kidney can play a contributory role in chronic critical illness and PICS.
The main goal of this project is to measure kidney filtration function at day 14 or the day of discharge from hospital (whichever occurs first), in order to determine the presence and magnitude of persistent kidney dysfunction after sepsis episode and to longitudinally assess further decline of kidney function at one year follow-up. The measure of the glomerular filtration rate (GRF) in patients with chronic critical illness and controls (sepsis patients discharged from ICU before day 14) will be used to determine to what degree of kidney dysfunction contributes to decreased survival and increase in chronic kidney disease at year one after sepsis onset.
GFR assessment will be determined at approximately day 14 or approximately at the day of discharge from the ICU and at the one-year follow-up:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhospital group at day 14 | Experimental | This group of sepsis participants remain hospitalized at day 14. GFR assessment is performed at inpatient day 14 and again at 1 year follow up. |
|
| Discharged prior to 14 days | Active Comparator | The group of patients were discharged before 14 days. GFR assessment at time of discharge and again at 1 year follow up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GFR by Iohexol | Diagnostic Test | Participants may receive a normal saline dilution of Iohexol 0.5-1 ml given by IV push. Blood or urine will be collected and measured to determine glomerular filtration rate measurements. This test will be repeated in one year. |
| Measure | Description | Time Frame |
|---|---|---|
| Delta Curve Between Calculated GFR and GFR Measured by Iohexol at Baseline | The difference between a measured GFR with Iohexol and calculated GFR from creatinine. | For Arm 1 baseline is measured GFR at 14 days inhospital with sepsis or sepsis diagnosis. For Arm 2 baseline is measured GFR at discharge date prior to day 14 of hospitalizaton with sepsis or sepsis diagnosis. |
| Delta Curve Between Calculated GFR and GFR Measured by Iohexol at 1 Year Follow-up. | The difference between a measured GFR with Iohexol and calculated GFR from creatinine This was a one-time determination at 1 year follow-up | one year follow up for both arms |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated GFR by Serum Creatinine | The correlation between iohexol glomerular filtration rate and estimated glomerular filtration rate using previously validated equation applied to serum creatinine in both groups. | at 14 days inpatient hospitalization or at discharge date prior to day 14 inpatient hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Segal, M.D. | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health at Shands hospital | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31856021 | Derived | Loftus TJ, Wu Q, Wang Z, Lysak N, Moore FA, Bihorac A, Efron PA, Mohr AM, Brakenridge SC. Delayed interhospital transfer of critically ill patients with surgical sepsis. J Trauma Acute Care Surg. 2020 Jan;88(1):169-175. doi: 10.1097/TA.0000000000002476. |
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73 subjects enrolled and 41 completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inhospital Group at Day 14 | This group of sepsis participants remain hospitalized at day 14. |
| FG001 | Discharged Prior to Hospital Day 14 | This group of sepsis participants were discharged prior to day 14. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | In Hospital Group at Day 14 | This group of sepsis participants remain hospitalized at day 14. A normal saline dilution of Iohexol 0.5-1 ml will be given IV push. |
| BG001 | Discharged From Hospital Prior to Day 14 |
| 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 | Delta Curve Between Calculated GFR and GFR Measured by Iohexol at Baseline | The difference between a measured GFR with Iohexol and calculated GFR from creatinine. | GFR by iohexol and eGFR by CKD epi at baseline. The iohexol could not be performed on many patients because it was contraindicated | Posted | Mean | Standard Deviation | ml/min/1.73m2 | For Arm 1 baseline is measured GFR at 14 days inhospital with sepsis or sepsis diagnosis. For Arm 2 baseline is measured GFR at discharge date prior to day 14 of hospitalizaton with sepsis or sepsis diagnosis. |
|
Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
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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 | Inhospital Group at Day 14 | This group of sepsis participants will remain hospitalized at day 14. GFR assessment at inpatient day 14 and again at 1 year follow up |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment | readmitted with a chief complaint of abdominal pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark S. Segal | University of Florida Board of Trustees Contracts & Grants | 352-273-5357 | segalms@medicine.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2015 | Jun 7, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 3, 2022 | Jun 7, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D059349 | Urine Specimen Collection |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Urine Collection | Diagnostic Test | Both groups of sepsis participants will have urine collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration. This test will be repeated in one year. |
|
| Blood samples | Diagnostic Test | Both groups of sepsis participants will provide peripheral blood samples to the research staff. The samples will be sent to the laboratory for serum creatinine results. This test will be repeated in one year. |
|
| Estimated GFR by Serum Creatinine |
The correlation between iohexol glomerular filtration rate and estimated glomerular filtration rate using previously validated equation applied to serum creatinine in both groups. |
| at 1 year follow-up |
| Calculated GFR by Urea Concentration and Creatinine Clearance | The urine will be collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration | at 14 days inpatient hospitalization or at discharge date prior to day 14 inpatient hospitalization |
| Calculated GFR by Urea Concentration and Creatinine Clearance | The urine will be collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration | at one year follow-up |
This group of sepsis participants were discharged prior to day 14 and iohexol determination of GFR was done at time of discharge. A normal saline dilution of Iohexol 0.5-1 ml will be given IV push.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| GFR by iohexol | The iohexol could not be performed in many individuals because it was contraindicated or the injection would interfere with patient care. | Mean | Standard Deviation | ml/min/1.7m2 |
|
| OG001 | Discharged Prior to Day 14 GFR | This group of sepsis participants will remain hospitalized after day 14. A normal saline dilution of Iohexol 0.5-1 ml will be given IV push. The iohexol will be quantified in urine and blood and glomerular filtration rate quantified. This test will be repeated in one year. In addition to or as an option would be to have a timed urine collection to determine clearance of urea and creatinine can be performed instead of the saline dilution of Iohexol 0.5-1 ml and/or an estimated of GFR using serum creatinine and cystatin C measurement using calculations from blood samples. Iohexol: Both groups of sepsis participants will receive a normal saline dilution of Iohexol 0.5-1 ml given by IV push. Blood or urine will be collected and measured to determine glomerular filtration rate measurements. This test will be repeated in one year. Urine Collection: Both groups of sepsis participants will have urine collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration. Blood samples: Both groups of sepsis participants will provide peripheral blood samples to the research staff. The samples will be sent to the laboratory for serum creatinine and cystatin C results. |
|
|
|
| Primary | Delta Curve Between Calculated GFR and GFR Measured by Iohexol at 1 Year Follow-up. | The difference between a measured GFR with Iohexol and calculated GFR from creatinine This was a one-time determination at 1 year follow-up | The iohexol could not be performed in many individuals because they could not come in to the clinic, would not come into the clinic, or the iohexol injection was contraindicated. | Posted | Mean | Standard Deviation | mL/min/1.73m2 | one year follow up for both arms |
|
|
|
| Secondary | Estimated GFR by Serum Creatinine | The correlation between iohexol glomerular filtration rate and estimated glomerular filtration rate using previously validated equation applied to serum creatinine in both groups. | Posted | Mean | Standard Deviation | mL/min/1.73m2 | at 14 days inpatient hospitalization or at discharge date prior to day 14 inpatient hospitalization |
|
|
|
| Secondary | Estimated GFR by Serum Creatinine | The correlation between iohexol glomerular filtration rate and estimated glomerular filtration rate using previously validated equation applied to serum creatinine in both groups. | Posted | Mean | Standard Deviation | ml/min/1.73m2 | at 1 year follow-up |
|
|
|
| Secondary | Calculated GFR by Urea Concentration and Creatinine Clearance | The urine will be collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration | this outcome measure was not performed due to lack of funding prior to initiation of study | Posted | at 14 days inpatient hospitalization or at discharge date prior to day 14 inpatient hospitalization |
|
|
| Secondary | Calculated GFR by Urea Concentration and Creatinine Clearance | The urine will be collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration | this outcome measure not performed due to funding cuts prior to initiation of study | Posted | at one year follow-up |
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|
| 6 |
| 41 |
| 24 |
| 41 |
| 0 |
| 41 |
| EG001 | Discharged From Hospital Prior to Day 14 | The group discharged before 14 days hospitalizaton. GFR assessment at discharge and again at 1 year follow-up | 1 | 32 | 15 | 32 | 0 | 32 |
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| colostomy reversal | Gastrointestinal disorders | Systematic Assessment | Readmission for colostomy reversal |
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| Blood Transfusion | Blood and lymphatic system disorders | Systematic Assessment |
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| Readmission for wound care | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Readmission for pacemaker implant | Cardiac disorders | Systematic Assessment |
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| Readmission for planned angiogram | Vascular disorders | Systematic Assessment |
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| Esophagael surgery | Gastrointestinal disorders | Systematic Assessment |
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| Chest pain | Cardiac disorders | Systematic Assessment |
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| Sepsis | General disorders | Systematic Assessment |
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| Altered Mental Status | General disorders | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Kidney Stones | Renal and urinary disorders | Systematic Assessment |
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| cholecystectomy | Hepatobiliary disorders | Systematic Assessment |
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| Hypotension | Cardiac disorders | Systematic Assessment |
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| Abdominal abscess | Infections and infestations | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pancreatic Surgery | Gastrointestinal disorders | Systematic Assessment |
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| Hemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| C. Diff infection | Infections and infestations | Systematic Assessment |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008919 | Investigative Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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