Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT02351934
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02351934
Study Brief:
Protocol Section:
NCT02351934