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NCT01539382 · ClinicalTrials.gov registry record · NA
Measuring and Treating Brain Oxygen Levels in Open Heart Surgery
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 140
- Enrollment target
NCT01539382 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 140 participants.
The verdict
NCT01539382, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
Study Summary
The purpose of this study is to test whether keeping the amount of oxygen delivered to the brain above a certain level during surgery and 24-hours after surgery improves recovery. Hypothesis 1: keeping the amount of oxygen delivered to the brain above a certain level during surgery and 24-hours after surgery improves cognitive and neurological outcomes after cardiac and aortic surgery. Hypothesis 2: keeping the amount of oxygen delivered to the brain above a certain level during surgery and 24-hours after surgery helps reduce major organ problems after cardiac and aortic surgery. To test our hypotheses, the investigators will conduct a randomized control trial. Patients will be randomly assigned to one of two possible study groups. In the Treatment Group, the brain oxygen level will be watched by doctors and used to guide care in the operating room and the first day in the intensive care unit after surgery. Doctors will try to keep the brain oxygen level in a normal range by adjusting your blood pressure, carbon dioxide and blood acidity levels, and blood count. In the Control Group, the doctors will not be aware of the brain oxygen level unless it falls below a level that may be dangerous. If a patient's brain oxygen falls below such a level, the doctors will adjust the blood pressure, carbon dioxide and blood acidity levels, and blood count to increase the brain oxygen level. All other procedures will be part of regular medical care and will be performed according to the standard of care.
Interventions
- PROCEDURE Cerebral oxygenation intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01539382
The ClinicalTrials.gov registry entry for NCT01539382 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cerebral oxygenation intervention is the first listed.
NCT01539382 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01539382 about?
NCT01539382 is a clinical study titled "Measuring and Treating Brain Oxygen Levels in Open Heart Surgery". The purpose of this study is to test whether keeping the amount of oxygen delivered to the brain above a certain level during surgery and 24-hours after surgery improves recovery. Hypothesis 1: keeping the amount of oxygen delivered to the brain above a certain level during surgery and 24-hours aft...
What is the current status of trial NCT01539382?
This trial is currently completed. It is a NA study. The enrollment target is 140 participants. The study started on 2011-11. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01539382?
The interventions under investigation include: Cerebral oxygenation intervention (PROCEDURE).
Who is sponsoring clinical trial NCT01539382?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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