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OpenTrials
Completed

NCT Number: NCT02351934

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

This study will assess if administration of a loop diuretic, specifically furosemide, to achieve euvolemia can safely reduce length of stay following colorectal surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furosemide

Drug

Other names: Lasix

Celecoxib

Drug

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

Other names: Celebrex

Gabapentin

Drug

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

Other names: Neurontin

Primary outcomes

  1. Length of Hospital Stay

    Time frame: Up to 7 days

    Participants will be followed for the duration of hospital stay, an expected average of 2-7 days.

Secondary outcomes

  1. Number of Participants Readmitted to Mayo Clinic Within 30-days

    Time frame: Within 30 days of release from hospital

  2. Number of Participants Requiring Nasogastric Tube Placement

    Time frame: Up to 7 days

  3. Time to Stool Output

    Time frame: Up to 4 days

  4. Number of Participants With Acute Kidney Injury

    Time frame: 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.

  5. Number of Participants With Hypokalemia

    Time frame: Up to 7 days

    Hypokalemia is generally defined as a serum potassium level of less than 3.5 mmol/L.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 30, 2015
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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