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Clinical Trials/NCT00991328
NCT00991328
Terminated
Phase 3

Tailored Patient Management Guided With Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery.

Icahn School of Medicine at Mount Sinai1 site in 1 country15 target enrollmentSeptember 2009

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Post-Operative Delirium
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
15
Locations
1
Primary Endpoint
The association of Postoperative Delirium (PD) and Postoperative Cognitive Dysfunction (POCD) with changes in cerebral tissue oxygen saturation (SctO2).
Status
Terminated
Last Updated
9 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
December 2010
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Postoperative Morbidity and Mortality(3 months postoperatively)

Study Sites (1)

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