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NCT02073162 · ClinicalTrials.gov registry record · NA
REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 3,000
- Enrollment target
NCT02073162: Completed NA study, sponsored by The Cleveland Clinic.
NCT02073162 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 3,000 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (114% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02073162, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 3,000 participants
- Enrollment target
Study 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 *
Primary Outcome
Disability was defined as a persistent impairment in health status (lasting ≥6 months), as measured by a score of at least 24 points on the WHODAS questionnaire, which reflects a disability level of at least 25% (the threshold point between "disabled" and "not disabled").
Interventions
- PROCEDURE Major Abdominal Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,000 participants |
| Start Date | 2014-02 |
| Est. Completion | 2018-02 |
| Phase | NA |
What the finished NCT02073162 record still lists
NCT02073162 is an interventional study that assigns participants to a tested intervention. Its 3,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (114% higher).
The record links to 0 conditions, and to 1 intervention - of which Major Abdominal Surgery is the first listed.
NCT02073162 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02073162 about?
NCT02073162 is a clinical study titled "REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery". 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 giv...
What is the current status of trial NCT02073162?
This trial is currently completed. It is a NA study. The enrollment target is 3,000 participants. The study started on 2014-02. Estimated completion is 2018-02.
What interventions are being tested in trial NCT02073162?
The interventions under investigation include: Major Abdominal Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT02073162?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02073162's enrollment target sits among peer trials
3,000 40th of 2000 higher than 1,959 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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