Measuring and Treating Brain Oxygen Levels in Open Heart Surgery

NCT01539382 | Completed DMC

• 1 other identifier: GCO 11-0891
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cardiac surgery; neurocognitive assessment; neurocognitive function

Outcome Measures

Primary Outcomes (3)

• Postoperative neurocognitive decline

  Postoperative cognitive deficit as defined as negative changes in Z-score of greater than or equal to 1.0 in any of the four neurocognitive domains tested by neurocognitive assessment (Response Speed, Processing Speed, Attention, and Memory).

  Baseline (before surgery)

• Postoperative neurocognitive decline

  Postoperative cognitive deficit as defined as negative changes in Z-score of greater than or equal to 1.0 in any of the four neurocognitive domains tested by neurocognitive assessment (Response Speed, Processing Speed, Attention, and Memory).

  3 months after surgery

• Postoperative neurocognitive decline

  Postoperative cognitive deficit as defined as negative changes in Z-score of greater than or equal to 1.0 in any of the four neurocognitive domains tested by neurocognitive assessment (Response Speed, Processing Speed, Attention, and Memory).

  6 months after surgery

Secondary Outcomes (2)

• Neurological dysfunction

  During the hospitalization for postoperative recovery, average 8 days

• Multiple organ dysfunction

  During the hospitalization for postoperative recovery, average 8 days

Study Arms (2)

Cerebral oxygenation intervention

EXPERIMENTAL

Cerebral oxygenation levels for people in this group will be monitored and maintained above 60%. If levels decrease to below 60%, a protocol is followed to guide possible interventions to increase cerebral oxygenation levels above 60%

Procedure: Cerebral oxygenation intervention

Cerebral oxygenation control

NO INTERVENTION

Cerebral oxygenation levels for people in this group will be masked and thus doctors and care staff will not use the cerebral oxygenation levels to make any interventions. If the cerebral oxygenation levels drop to below 40%, the cerebral oxygenation levels will be unmasked so that doctors can follow the protocol to increase levels to above 60%.

Interventions

Cerebral oxygenation intervention PROCEDURE

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.

Also known as: Intervention

Cerebral oxygenation intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients scheduled to undergo elective cardiac or thoracic aortic surgery requiring cardiopulmonary bypass

You may not qualify if:

• Severe preoperative cognitive impairment (i.e., dementia or developmental intellectual disability)
• Sensory or motor impairment that would preclude reliable operation of a computer and keyboard
• Lack of access to use computer-based cognitive evaluation
• Non-English speaking patients
• Renal failure requiring dialysis
• Respiratory failure requiring home oxygen use
• Child's B or C hepatic failure

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Muoi Trinh, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: February 27, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 23, 2015

Record last verified: 2015-10

Locations

US (1)