Clinical trial NCT02351934: Early Diuresis Following Colorectal Surgery
Official title: A Prospective, Randomized Study Evaluating the Efficacy and Safety of Early Diuresis Following Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Disorders
Keywords: colorectal surgery
volume status
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: Up to 7 days
Secondary outcomes:
measure: Number of Participants Readmitted to Mayo Clinic Within 30-days
timeFrame: Within 30 days of release from hospital
measure: Number of Participants Requiring Nasogastric Tube Placement
timeFrame: Up to 7 days
measure: Time to Stool Output
timeFrame: Up to 4 days
measure: Number of Participants With Acute Kidney Injury
timeFrame: Up to 7 days
measure: Number of Participants With Hypokalemia
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ilya Danelich, PharmD, RPh
role: PRINCIPAL_INVESTIGATOR
References: