REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery
Public ClinicalTrials.gov record NCT02073162. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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)
Study identification
- NCT ID
- NCT02073162
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 3,000 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2014
- Primary completion
- Aug 31, 2016
- Completion
- Jan 31, 2018
- Last update posted
- Oct 30, 2019
2014 – 2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02073162, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 30, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02073162 live on ClinicalTrials.gov.