Phase 4
Completed N=123
Early Diuresis Following Colorectal Surgery
Colorectal Disorders
Source: ClinicalTrials.gov NCT02351934 ↗
Enrolled (actual)
123
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Length of Hospital Stay — 99.6; 80.6 hours — p=0.564
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Hospital Stay |
99.6; 80.6 | 0.564 |
| SECONDARY Number of Participants Readmitted to Mayo Clinic Within 30-days |
13; 10 | 0.675 |
| SECONDARY Number of Participants Requiring Nasogastric Tube Placement |
6; 1 | 0.125 |
| SECONDARY Time to Stool Output |
48.8; 45.4 | — |
| SECONDARY Number of Participants With Acute Kidney Injury |
2; 2 | 0.595 |
| SECONDARY Number of Participants With Hypokalemia |
2; 3 | 0.985 |
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
Data sourced from ClinicalTrials.gov (NCT02351934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.