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Measuring and Treating Brain Oxygen Levels in Open Heart Surgery

NCT01539382 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2015-10-23

No results posted yet for this 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.

Conditions

  • Cardiac Surgery

Interventions

PROCEDURE

Cerebral oxygenation intervention

The protocol for interventions to increase cerebral oxygenation levels above 60% optimizing pH, PaO2, PaCO2, bispectral index, central venous pressure, mean arterial pressure, venous oxygen saturation, and hematocrit. In addition, cerebral perfusion pressure of 70-80 mm Hg and flow \>2.0 l/min/m2 will be maintained during cardiopulmonary bypass. In the ICU, temperatures will be maintained below 38 degrees by administering antipyretics or cooling, and dexmedetomidine will be used if the patient is agitated.

Sponsors & Collaborators

Principal Investigators

  • Muoi Trinh, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01539382 on ClinicalTrials.gov