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REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery

NCT02073162 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2019-10-31

Study results available
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Summary

Physicians differ in their approaches to surgical fluid therapy, with some preferring higher volumes and others lower volumes. Each approach has potential advantages and disadvantages. Currently, there is no compelling evidence that one approach is better than the other. This study tests whether giving a volume on the low end of the usual amount ("restrictive management") has a different rate of complications compared to a volume on the high end of the usual amount ("liberal management"). This study will compare liberal and restrictive fluid management to determine their effects on major complications after abdominal surgery.

Those who take part in the study will be visited five times before and after surgery in the hospital. Once discharged from the hospital, participants will be called 4 times on the telephone.

Preadmission Clinic/Preoperative Visit

* Sign the consent document
* Have blood drawn for standard preoperative tests (standard of care)
* Have an electrocardiogram (standard of care)
* Complete a questionnaire on disability (research)

Day of Surgery

* Have blood drawn if not already done during the first visit (standard of care)
* Have an electrocardiogram if not already done during the first visit (standard of care)
* Be randomly assigned to either restrictive or liberal fluid management (research)

Post-op Day 1

* Have an electrocardiogram done (research)
* Have blood drawn for standard tests (standard of care)
* Have a wound inspection, if there is a change of dressing (standard of care)
* Complete a questionnaire about your recovery (research)

Post-op Day 3

* Have blood drawn for standard tests (standard of care) and c-reactive protein, which can indicate infection (for research).
* Have a wound inspection, if there is a change of dressing (standard of care)
* Complete a questionnaire about your recovery (research)

Day of Discharge

* Have a wound inspection, if there is a change of dressing (standard of care)

30-Day Follow-up Phone Call
* Complete a questionnaire about your recovery (research)
* Complete a questionnaire about disability (research)

3 Month, 6-Month, and 12-Month Follow-up Phone Calls
* Complete a questionnaire about disability (research)

Conditions

  • Major Abdominal Surgery

Interventions

PROCEDURE

Major Abdominal Surgery

•All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Andrea Kurz · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-09-30
Completion
2018-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02073162 on ClinicalTrials.gov