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

October 2, 2009
October 7, 2009
September 2009
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00991328 on ClinicalTrials.gov Archive Site
Postoperative Morbidity and Mortality [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Role of Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery
Tailored Patient Management Guided With Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery.

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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
  • Post-Operative Delirium
  • Postoperative Cognitive Dysfunction
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.
  • 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.
    Intervention: Procedure: SctO2 < 60 %.
  • 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%

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
Yes
Contact: Gregory Fischer, M.D. 212-241-7749 gregory.fischer@mountsinai.org
Contact: Dionne Bobb, M.S, CCRC dionne.bobb@mountsinai.org
United States
 
NCT00991328
GCO # 07-0332
Yes
Gregory Fischer, MD, Mount Sinai School of Medicine (MSSM)
Mount Sinai School of Medicine
Not Provided
Principal Investigator: Gregory Fischer, M.D. Mount Sinai School of Medicine
Mount Sinai School of Medicine
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP