Early Diuresis Following Colorectal Surgery

Phase 4

Completed

• Conditions: Colorectal Disorders
• Interventions: Drug: Furosemide; Drug: Celecoxib; Drug: Gabapentin

• Registration Number: NCT02351934
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2015-01-23
• Study First Submitted QC: 2015-01-27
• Study First Posted: 2015-01-30
• Study Start: 2015-02
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Results First Submitted: 2017-06-02
• Results First Submitted QC: 2017-06-02
• Results First Posted: 2017-06-27
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Furosemide + Enhanced Recovery after Surgery (ERAS)	Celecoxib	Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
Furosemide + Enhanced Recovery after Surgery (ERAS)	Gabapentin	Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
Furosemide + Enhanced Recovery after Surgery (ERAS)	Furosemide	Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
Enhanced Recovery after Surgery (ERAS)	Celecoxib	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.
Enhanced Recovery after Surgery (ERAS)	Gabapentin	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.

Primary Outcome Measures

Name	Time	Method
Length of Hospital Stay	Up to 7 days	Participants will be followed for the duration of hospital stay, an expected average of 2-7 days.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Readmitted to Mayo Clinic Within 30-days	Within 30 days of release from hospital
Number of Participants Requiring Nasogastric Tube Placement	Up to 7 days
Time to Stool Output	Up to 4 days
Number of Participants With Acute Kidney Injury	Up to 7 days	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.
Number of Participants With Hypokalemia	Up to 7 days	Hypokalemia is generally defined as a serum potassium level of less than 3.5 mmol/L.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States