Early Diuresis Following Colorectal Surgery

Colorectal Disorders Clinical Trial

Official title:

A Prospective, Randomized Study Evaluating the Efficacy and Safety of Early Diuresis Following Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351934
• Other study ID #: 14-008292
• Secondary ID: UL1TR000135
• Status: Completed
• Phase: Phase 4
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Disorders

Intervention

Drug:
• Furosemide

• Celecoxib
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation.
• Gabapentin
Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Hospital Stay	Participants will be followed for the duration of hospital stay, an expected average of 2-7 days.	Up to 7 days
Secondary	Number of Participants Readmitted to Mayo Clinic Within 30-days		Within 30 days of release from hospital
Secondary	Number of Participants Requiring Nasogastric Tube Placement		Up to 7 days
Secondary	Time to Stool Output		Up to 4 days
Secondary	Number of Participants With Acute Kidney Injury	Acute kidney injury (AKI) refers to an abrupt decrease in kidney function, resulting in the retention of urea and other nitrogenous waste products and in the dysregulation of extracellular volume and electrolytes. The term AKI has largely replaced acute renal failure (ARF), reflecting the recognition that smaller decrements in kidney function that do not result in overt organ failure are of substantial clinical relevance and are associated with increased morbidity and mortality. The AKI experienced by these patients was not considered an adverse event.	Up to 7 days
Secondary	Number of Participants With Hypokalemia	Hypokalemia is generally defined as a serum potassium level of less than 3.5 mmol/L.	Up to 7 days