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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000135 | U.S. NIH Grant/Contract | View source |
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The purpose of this study is to find out if giving a medicine called furosemide, which is a diuretic or water pill, after colon surgery will safely shorten the patient's length of hospital stay.
This study will assess if administration of a loop diuretic, specifically furosemide, to achieve euvolemia can safely reduce length of stay following colorectal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furosemide + Enhanced Recovery after Surgery (ERAS) | Experimental | Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm. |
|
| Enhanced Recovery after Surgery (ERAS) | Active Comparator | ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Participants will be followed for the duration of hospital stay, an expected average of 2-7 days. | Up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Readmitted to Mayo Clinic Within 30-days | Within 30 days of release from hospital | |
| Number of Participants Requiring Nasogastric Tube Placement | Up to 7 days | |
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Inclusion Criteria
Exclusion Criteria
Exclusion Criteria for Randomization:
Exclusion Criteria for Intervention (applies to both the intervention and control arm):
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| Name | Affiliation | Role |
|---|---|---|
| Ilya Danelich, PharmD, RPh | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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Subjects were enrolled at Mayo Clinic in Rochester, Minnesota between February 2015 and April 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Furosemide + Enhanced Recovery After Surgery (ERAS) | Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm. |
| FG001 | Enhanced Recovery After Surgery (ERAS) | ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allocation |
|
| ||||||||||||||||||||||||
| Follow-Up |
|
Intention to treat analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Furosemide + Enhanced Recovery After Surgery (ERAS) | Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm. |
| BG001 | Enhanced Recovery After Surgery (ERAS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Length of Hospital Stay | Participants will be followed for the duration of hospital stay, an expected average of 2-7 days. | Intent to treat analysis | Posted | Median | Inter-Quartile Range | hours | Up to 7 days |
|
1 month
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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 | Furosemide + Enhanced Recovery After Surgery (ERAS) | Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased Potassium | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ilya Danelich, Pharm.D., R.Ph. | Mayo Clinic | 507-255-5732 | Danelich.Ilya@mayo.edu |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| D000068579 | Celecoxib |
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Celecoxib |
| Drug |
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation. |
|
|
| Gabapentin | Drug | Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome. |
|
|
| Time to Stool Output |
| Up to 4 days |
| Number of Participants With Acute Kidney Injury | Acute kidney injury (AKI) refers to an abrupt decrease in kidney function, resulting in the retention of urea and other nitrogenous waste products and in the dysregulation of extracellular volume and electrolytes. The term AKI has largely replaced acute renal failure (ARF), reflecting the recognition that smaller decrements in kidney function that do not result in overt organ failure are of substantial clinical relevance and are associated with increased morbidity and mortality. The AKI experienced by these patients was not considered an adverse event. | Up to 7 days |
| Number of Participants With Hypokalemia | Hypokalemia is generally defined as a serum potassium level of less than 3.5 mmol/L. | Up to 7 days |
| Acute Kidney Injury on Post Op Day 1 |
|
| NOT COMPLETED |
|
|
ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | Number of Participants Readmitted to Mayo Clinic Within 30-days | Intention to treat analysis | Posted | Count of Participants | Participants | Within 30 days of release from hospital |
|
|
|
|
| Secondary | Number of Participants Requiring Nasogastric Tube Placement | Intention to Treat Analysis | Posted | Count of Participants | Participants | Up to 7 days |
|
|
|
|
| Secondary | Time to Stool Output | Intention to treat analysis | Posted | Median | Inter-Quartile Range | hours | Up to 4 days |
|
|
|
| Secondary | Number of Participants With Acute Kidney Injury | Acute kidney injury (AKI) refers to an abrupt decrease in kidney function, resulting in the retention of urea and other nitrogenous waste products and in the dysregulation of extracellular volume and electrolytes. The term AKI has largely replaced acute renal failure (ARF), reflecting the recognition that smaller decrements in kidney function that do not result in overt organ failure are of substantial clinical relevance and are associated with increased morbidity and mortality. The AKI experienced by these patients was not considered an adverse event. | Intention to treat analysis | Posted | Count of Participants | Participants | Up to 7 days |
|
|
|
|
| Secondary | Number of Participants With Hypokalemia | Hypokalemia is generally defined as a serum potassium level of less than 3.5 mmol/L. | Intention to treat analysis | Posted | Count of Participants | Participants | Up to 7 days |
|
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 8 |
| 62 |
| EG001 | Enhanced Recovery After Surgery (ERAS) | ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale. | 0 | 61 | 0 | 61 | 3 | 61 |
| Increased Serum Creatinine | Renal and urinary disorders | Systematic Assessment | If your kidneys aren't functioning properly, an increased level of creatinine may accumulate in your blood. |
|
| Decreased blood pressure | Cardiac disorders | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Urine leak | Renal and urinary disorders | Systematic Assessment |
|
| Increased heart rate | Cardiac disorders | Systematic Assessment |
|
| Increased temperature | General disorders | Systematic Assessment |
|
| Hematoma/Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D000096926 | Benzenesulfonamides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |