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
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Surgery
Other: Quality improvement intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Redesigning Cardiac Surgery to Reduce Neurologic Injury

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

Serum to study neurologic biomarker, Sb100.


Enrollment: 469
Study Start Date: October 2002
Study Completion Date: February 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Quality improvement intervention
    determine the effectiveness of adopting quality improvement strategies to reduce embolization, hypotension and cerebral desaturation
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing cardiac surgery.

Criteria

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

  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: NCT00432536

Locations
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Catholic Medical Center
Manchester, New Hampshire, United States, 03102
Sponsors and Collaborators
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
Investigators
Principal Investigator: Donald S Likosky, Ph.D. Dartmouth-Hitchcock Medical Center
Study Director: David J. Malenka, MD Dartmouth-Hitchcock Medical Center
  More Information

Publications:

Responsible Party: David J. Malenka, Professor of Medicine, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00432536     History of Changes
Other Study ID Numbers: 20307, 1K02HS015663-01A1
Study First Received: February 7, 2007
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Neuro-monitoring
Quality Improvement
Cerebral emboli
Cerebral desaturation
Hypotension

Additional relevant MeSH terms:
Cardiovascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on July 29, 2014