Early Diuresis Following Colorectal Surgery

NCT02351934 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 14-008292UL1TR000135
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Disorders

Keywords

colorectal surgery; volume status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Number of Participants With Hypokalemia

  Up to 7 days

Study Arms (2)

Furosemide + Enhanced Recovery after Surgery (ERAS)

EXPERIMENTAL

Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.

Drug: Furosemide; Drug: Celecoxib; Drug: Gabapentin

Enhanced Recovery after Surgery (ERAS)

ACTIVE COMPARATOR

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; Drug: Gabapentin

Interventions

Furosemide DRUG

Also known as: Lasix

Furosemide + Enhanced Recovery after Surgery (ERAS)

Celecoxib DRUG

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation.

Also known as: Celebrex

Enhanced Recovery after Surgery (ERAS); Furosemide + Enhanced Recovery after Surgery (ERAS)

Gabapentin DRUG

Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome.

Also known as: Neurontin

Enhanced Recovery after Surgery (ERAS); Furosemide + Enhanced Recovery after Surgery (ERAS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All elective colorectal surgeries (CRS) utilizing the enhanced recovery pathway (ERP)
• The surgery involves resection

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Furosemide; Celecoxib; Gabapentin

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Benzenesulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Ilya Danelich, Pharm.D., R.Ph.
• Organization: Mayo Clinic

Danelich.Ilya@mayo.edu

507-255-5732

Study Officials

• Ilya Danelich, PharmD, RPh

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: January 30, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 7, 2018
• Results First Posted: June 27, 2017

Record last verified: 2018-04

Locations

US (1)