Early Diuresis Following Colorectal Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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This study will assess if administration of a loop diuretic, specifically furosemide, to achieve euvolemia can safely reduce length of stay following colorectal surgery.

Official Title
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A Prospective, Randomized Study Evaluating the Efficacy and Safety of Early Diuresis Following Colorectal Surgery

Conditions
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Colorectal Disorders

Intervention / Treatment
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* Drug: Furosemide
* Drug: Celecoxib
* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria All elective colorectal surgeries (CRS) utilizing the enhanced recovery pathway (ERP) The surgery involves resection Exclusion Criteria Exclusion Criteria for Randomization: Surgeries involving intraoperative radiation Ileostomy closures, when performed as the only surgical intervention Surgeries involving multiple disciplines (e.g., colorectal plus general surgery, colorectal plus gynecology surgery) except for colorectal surgeries plus ureteral stent placements. Chronic loop diuretic therapy (i.e., bumetanide, torsemide, furosemide, ethacrynic acid) including as needed administration of such therapy Patients receiving dialysis Creatinine clearance, calculated by the Cockcroft-Gault equation, less than 30 mL/min. Inpatient prior to surgery Allergy to furosemide Allergy to sulfa drugs if the allergy involves anaphylactic reaction Lack of serum creatinine concentration within 3 months preceding the surgery AND diagnosis of chronic kidney disease Exclusion Criteria for Intervention (applies to both the intervention and control arm): Patient's weight on postoperative day (POD) #1 and POD #2 is less than preoperative weight. Blood pressure criteria: systolic blood pressure criteria less than 90 mmHg or greater than 30 mmHg below baseline on POD #1 and/or POD #2 immediately prior to administration of study drug. Complications within 48 hours of surgery Abscess (infected fluid collection, treated with CT drainage) Leak (defined by CT drainage or reoperation) Wound infection (treated with either antibiotics and/or open packing) Bowel obstruction (treated with reoperation) Reoperation Hemorrhage Weight change since admission on POD #1: > 5 kg Acute kidney injury on POD #1 and POD#2 defined as serum creatinine (SCr) increase ≥ 0.3 mg/dL or increase to ≥ 150% to 200% (1.5- to 2-fold) from baseline

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Furosemide + Enhanced Recovery after Surgery (ERAS)<br>Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm. | Drug: Furosemide<br> <br> * Other names: Lasix;Drug: Celecoxib<br>* Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation.<br>* Other names: Celebrex;Drug: Gabapentin<br>* Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome.<br>* Other names: Neurontin;|
| Active Comparator: Enhanced Recovery after Surgery (ERAS)<br>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. | Drug: Celecoxib<br>* Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation.<br>* Other names: Celebrex;Drug: Gabapentin<br>* Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome.<br>* Other names: Neurontin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal surgery, volume status