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Early Diuresis Following Colorectal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02351934
Recruitment Status : Completed
First Posted : January 30, 2015
Results First Posted : June 27, 2017
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Ilya M. Danelich, Pharm.D., R.Ph., 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.

Condition or disease Intervention/treatment Phase
Colorectal Disorders Drug: Furosemide Drug: Celecoxib Drug: Gabapentin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study Evaluating the Efficacy and Safety of Early Diuresis Following Colorectal Surgery
Actual Study Start Date : February 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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 Name: Lasix

Drug: Celecoxib
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation.
Other Name: Celebrex

Drug: Gabapentin
Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome.
Other Name: 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 Name: Celebrex

Drug: Gabapentin
Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome.
Other Name: Neurontin




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351934


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Ilya Danelich, PharmD, RPh Mayo Clinic

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Responsible Party: Ilya M. Danelich, Pharm.D., R.Ph., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02351934     History of Changes
Other Study ID Numbers: 14-008292
UL1TR000135 ( U.S. NIH Grant/Contract )
First Posted: January 30, 2015    Key Record Dates
Results First Posted: June 27, 2017
Last Update Posted: May 7, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ilya M. Danelich, Pharm.D., R.Ph., Mayo Clinic:
colorectal surgery
volume status

Additional relevant MeSH terms:
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Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Gabapentin
Furosemide
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
Diuretics
Natriuretic Agents
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators