Early Diuresis Following Colorectal Surgery

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Celecoxib; Furosemide; Gabapentin

Criteria

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