Early Diuresis Following Colorectal Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Disorders
• Intervention / Treatment: Drug: Furosemide; Drug: Celecoxib; Drug: Gabapentin

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 Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Furosemide + Enhanced Recovery after Surgery (ERAS); Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.	Drug: Furosemide; Other Names: Lasix; Drug: Celecoxib; Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation.; Other Names: Celebrex; Drug: Gabapentin; Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome.; Other Names: Neurontin
Active Comparator: Enhanced Recovery after Surgery (ERAS); 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.	Drug: Celecoxib; Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation.; Other Names: Celebrex; Drug: Gabapentin; Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome.; Other Names: Neurontin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ilya Danelich, PharmD, RPh, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: January 23, 2015
• First Submitted That Met QC Criteria: January 27, 2015
• First Posted (Estimate): January 30, 2015

Study Record Updates

• Last Update Posted (Actual): May 7, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: colorectal surgery; volume status
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Natriuretic Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Diuretics; Anticonvulsants; Antimanic Agents; Cyclooxygenase 2 Inhibitors; Sodium Potassium Chloride Symporter Inhibitors; Gabapentin; Celecoxib; Furosemide
• Other Study ID Numbers: 14-008292; UL1TR000135 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No