Early Diuresis Following Colorectal Surgery

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Colorectal Disorders

Treatments: Drug: Celecoxib; Drug: Gabapentin; Drug: Furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT02351934

UL1TR000135 (U.S. NIH Grant/Contract)

14-008292

Details and patient eligibility

About

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.

Full description

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

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

Furosemide + Enhanced Recovery after Surgery (ERAS)

Experimental group

Description:

Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.

Treatment:

Drug: Furosemide

Drug: Gabapentin

Drug: Celecoxib

Enhanced Recovery after Surgery (ERAS)

Active Comparator group

Description:

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.

Treatment:

Drug: Gabapentin

Drug: Celecoxib