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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 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 3,000 participants.
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 *
Interventions
- PROCEDURE Major Abdominal Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,000 participants |
| Start Date | 2014-02 |
| Est. Completion | 2018-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02073162
The ClinicalTrials.gov registry entry for NCT02073162 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 3,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Major Abdominal Surgery is the first listed.
NCT02073162 reports 0 study locations.
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.
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