Role of Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Mount Sinai School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00991328
First received: October 2, 2009
Last updated: October 7, 2009
Last verified: October 2009
  Purpose

The purpose of this study is to determine whether brain oxygenation measured by cerebral oximeter has an impact on neurocognitive dysfunction.


Condition Intervention Phase
Post-Operative Delirium
Postoperative Cognitive Dysfunction
Procedure: SctO2 < 60 %.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Tailored Patient Management Guided With Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery.

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • The association of Postoperative Delirium (PD) and Postoperative Cognitive Dysfunction (POCD) with changes in cerebral tissue oxygen saturation (SctO2). [ Time Frame: First 5 days after the cardiac surgery. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative Morbidity and Mortality [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cerebral Desaturation, i.e; SctO2 < 60 % for 5 minutes
Once the cerebral desaturation is established, the study personnel will attempt to optimize the level of oxygen within the brain of the study patients.
Procedure: SctO2 < 60 %.
The following intervention protocol will be applied when SctO2 level falls below 60 %. First, the patients head position will be checked for suitable position and the face will be observed for plethora. Then the efforts will be made to maintain PaCO2 between 40-50 mmHg and MAP of 60 - 80 mm Hg. Cardiac index will be maintained between 2.0 - 2.5 L/min/m2. The hematocrit should be more than 20 %. The red blood cells or hemoconcentration will be used for this purpose.
No Intervention: Patients with SctO2 less than 60 %.
The study patients will not get any intervention in this arm if the Sct02 falls below 60%

Detailed Description:

Both postoperative delirium (PD) and postoperative cognitive dysfunction (POCD) are well known complications seen in elderly patients after cardiac surgery. The etiologies of PD and POCD are unknown, but cerebral ischemia remains a prime candidate. Attempts to correlate reduced levels of systemic oxygenation (i.e. SpO2) with the development of PD/POCD have been to date disappointing.

We believe that cerebral oximetry, a noninvasive technology that continuously monitors cerebral tissue oxygen saturation (SctO2), will enable us to answer the question of whether or not a correlation exists.

The availability of an absolute cerebral oximeter (FORE-SIGHT), with its ability to establish and manipulate threshold values for SctO2, provides us the opportunity to assess the relationship between cerebral oxygenation and the development of neurocognitive complications.

We propose a randomized, masked trial of 120 patients, adequately powered to assess the following:

  • Is there an association between deficits in cerebral oxygenation and the occurrence of PD at some time in the 1st 5 days after the operation?
  • Is there an association between deficits in cerebral oxygenation and changes in POCD scores shortly (5 days) after the operation and/or 4-6 weeks later? We hypothesize that individually tailored patient management guided with intraoperative and postoperative absolute cerebral oximetry monitoring using a tailored protocol designed to maintain SctO2 values above a specific threshold will result in improved neurocognitive outcomes in geriatric patients undergoing cardiac surgery.
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 65 and older
  • Elective cardiac or thoracic aortic surgery
  • Capable and willing to consent
  • Participants literate in English

Exclusion Criteria:

  • Emergency Surgery
  • Major Neurological Disease
  • Gross Cognitive Dysfunction
  • Patients not expected to be able to complete the 1 week and 3 months post-operative visit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991328

Contacts
Contact: Gregory Fischer, M.D. 212-241-7749 gregory.fischer@mountsinai.org
Contact: Dionne Bobb, M.S, CCRC dionne.bobb@mountsinai.org

Locations
United States, New York
Mount Sinai School of Medicine Not yet recruiting
New York, New York, United States, 10029
Contact: Gregory Fischer, M.D.    212-241-7749    gregory.fischer@mountsinai.org   
Contact: Ajay Satayapriya, M.D.       ajay.satyapriya@mountsinai.org   
Principal Investigator: Gregory Fischer, M.D.         
Sub-Investigator: Ajay Satayapriya, M.D.         
Sub-Investigator: Muhammad Nauman, M.D.         
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Gregory Fischer, M.D.    212-241-7749    gregory.fischer@mountsinai.org   
Contact: Muhammad Nauman, M.D.    212-241-7749    muhammad.nauman@mountsinai.org   
Principal Investigator: Gregory Fischer, M.D.         
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Gregory Fischer, M.D. Mount Sinai School of Medicine
  More Information

Publications:

Responsible Party: Gregory Fischer, MD, Mount Sinai School of Medicine (MSSM)
ClinicalTrials.gov Identifier: NCT00991328     History of Changes
Other Study ID Numbers: GCO # 07-0332
Study First Received: October 2, 2009
Last Updated: October 7, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
PD
POCD
Post-op Delirium (PD)
Post-op Cognitive Dysfunction (POCD)

Additional relevant MeSH terms:
Delirium
Cognition Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014