Redesigning Cardiac Surgery to Reduce Neurologic Injury

This study has been completed.
Sponsor:
Collaborators:
Maine Medical Center
Catholic Medical Center
Somanetics Corporation
Sorin Group
Maquet Cardiovascular
Northern New England Cardiovascular Disease Study Group
Luna Innovations
Information provided by (Responsible Party):
David J. Malenka, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00432536
First received: February 7, 2007
Last updated: May 14, 2013
Last verified: May 2013

February 7, 2007
May 14, 2013
October 2002
August 2011   (final data collection date for primary outcome measure)
Emboli and Hypoperfusion Counts [ Time Frame: within the operative time period ] [ Designated as safety issue: No ]
We will count the number of thrombotic/lipid emboli and number of gaseous emboli. Along with the number of hypotensive events. We will link counts to surgical and perfusion techniques.
  • Hypotension
  • Cerebral desaturation
  • Adherence to quality improvement bundles
  • Embolic Load
Complete list of historical versions of study NCT00432536 on ClinicalTrials.gov Archive Site
  • Type I and II neurologic injuries [ Time Frame: within 3 months after surgery ] [ Designated as safety issue: No ]
    We will measure a patient's neurologic status Using a Telephone Interview for Cognitive Status tool at 3 time periods (prior to surgery, prior to discharge and at 3 months)
  • Tissue-level neurologic injury [ Time Frame: within 48 hrs of surgery ] [ Designated as safety issue: No ]
    Blood for serum markers will be collected after surgery. We will assess plasma levels of biochemical markers of neurology injury.
  • Type I/II neurologic injuries
  • Tissue-level neurologic injury
Not Provided
Not Provided
 
Redesigning Cardiac Surgery to Reduce Neurologic Injury
Redesigning Cardiac Surgery to Reduce Neurologic Injury

Neurologic injuries are frequent and devastating complications following cardiac surgery. Previous work conducted by our research group and others has identified the principal mechanisms creating both overt and subtle neurologic injuries after cardiac surgery. Current work by our group has identified that the causes (thrombotic/lipid emboli, cerebral hypoperfusion & hypotension, and gaseous emboli) of these injuries are byproducts of processes of surgical and perfusion care. This insight suggests that the redesign of clinical strategies and techniques to prevent the occurrence of these intraoperative sources of damage may provide an opportunity to reduce the risk of neurologic injury after cardiac surgery.

The goal of this research is to identify modifiable clinical strategies and techniques of surgical and perfusion care associated with the causes (thrombotic/lipid emboli, cerebral hypoperfusion & hypotension, and gaseous emboli) of neurologic injury secondary to coronary artery bypass graft (CABG) surgery, and subsequently to redesign these processes to reduce a patient's risk of a neurologic injury.

The goal of this research is to identify modifiable clinical strategies and techniques of surgical and perfusion care associated with the causes (thrombotic/lipid emboli, cerebral hypoperfusion & hypotension, and gaseous emboli) of neurologic injury secondary to coronary artery bypass graft (CABG) surgery, and subsequently to redesign these processes to reduce a patient's risk of a neurologic injury. The following hypotheses will be addressed.

Hypothesis #1a. Identifying alternative strategies for conducting processes of surgical and perfusion care will reveal opportunities to reduce the occurrence of causes of neurologic injury. The most common mechanisms creating neurologic injury, whether focal or global, after CABG surgery are thrombotic/lipid emboli, cerebral hypoperfusion & hypotension, and gaseous emboli. Processes of surgical and perfusion care are associated with the creation of each of these causes of neurologic injury.

Hypothesis #1b. Redesigning processes of surgical and perfusion care to reduce thrombotic/lipid emboli, cerebral hypoperfusion & hypotension, and gaseous emboli during CABG surgery will result in reductions of tissue-level and neurologic injury. We will analyze sera for tissue-level brain injury as well as identify any new neurologic injuries present among patients undergoing CABG surgery. Redesigning CABG surgery to reduce thrombotic/lipid emboli, cerebral hypoperfusion & hypotension, and gaseous emboli will result in decreases in tissue-level and neurologic injury.

Hypothesis #2. A regional quality improvement intervention will result in changes to surgical and perfusion techniques. Regional dissemination of the findings from Hypotheses #1a,b may be realized through focused quality improvement initiatives utilizing multidisciplinary clinical teams.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum to study neurologic biomarker, Sb100.

Non-Probability Sample

Patients undergoing cardiac surgery.

  • Cardiovascular Disease
  • Surgery
Other: Quality improvement intervention
determine the effectiveness of adopting quality improvement strategies to reduce embolization, hypotension and cerebral desaturation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
469
February 2012
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients aged 40-89 years undergoing nonemergency coronary revascularization or valve procedures with or without the use of a cardiopulmonary bypass circuit.

Exclusion Criteria:

- Undergoing concomitant procedures besides cardiac surgery

Both
40 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00432536
20307, 1K02HS015663-01A1
No
David J. Malenka, Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
  • Maine Medical Center
  • Catholic Medical Center
  • Somanetics Corporation
  • Sorin Group
  • Maquet Cardiovascular
  • Northern New England Cardiovascular Disease Study Group
  • Luna Innovations
  • Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Donald S Likosky, Ph.D. Dartmouth-Hitchcock Medical Center
Study Director: David J. Malenka, MD Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
May 2013

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