Redesigning Cardiac Surgery to Reduce Neurologic Injury

NCT00432536 | Completed

• 2 other identifiers: 203071K02HS015663-01A1
• Study Type: observational
• Target: 469
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Cardiovascular Disease; Surgery

Keywords

Neuro-monitoring; Quality Improvement; Cerebral emboli; Cerebral desaturation; Hypotension

Outcome Measures

Primary Outcomes (1)

• Emboli and Hypoperfusion Counts

  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.

  within the operative time period

Secondary Outcomes (2)

• Type I and II neurologic injuries

  within 3 months after surgery

• Tissue-level neurologic injury

  within 48 hrs of surgery

Interventions

Quality improvement intervention OTHER

determine the effectiveness of adopting quality improvement strategies to reduce embolization, hypotension and cerebral desaturation

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardiac surgery.

You may qualify if:

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

You may not qualify if:

• \- Undergoing concomitant procedures besides cardiac surgery

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• MaineHealth: collaborator
• Catholic Medical Center: collaborator
• Somanetics Corporation: collaborator
• LivaNova: collaborator
• Maquet Cardiovascular: collaborator
• Northern New England Cardiovascular Disease Study Group: collaborator
• Luna Innovations: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (3)

Maine Medical Center

Portland, Maine, 04102, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Related Publications (6)

• Likosky DS, Donegan DJ, Groom RC, Buchanan SA, Morton JR, Ross CS, O'Connor GT. Embolic activity subsequent to injection of the internal mammary artery with papaverine hydrochloride. Heart Surg Forum. 2005;8(6):E434-6. doi: 10.1532/HSF98.20051012.

  PMID: 16283980 RESULT

• Likosky DS, Groom RC, Clark C, Forest RJ, Kramer RS, Morton JR, Ross CS, Sabadosa KA, O'Connor GT; Northern New England Cardiovascular Disease Study Group, Lebanon, New Hampshire. A method for identifying mechanisms of neurologic injury from cardiac surgery. Heart Surg Forum. 2004;7(6):348-52. doi: 10.1532/HSF98.20041088.

  PMID: 15769702 RESULT

• Groom R, Likosky DS, Rutberg H. Understanding variation in cardiopulmonary bypass: Statistical Process Control Theory. J Extra Corpor Technol. 2004 Sep;36(3):224-30. No abstract available.

  PMID: 15559738 RESULT

• Groom RC, Likosky DS, Forest RJ, O'Connor GT, Morton JR, Ross CS, Clark C, Kramer R. A model for cardiopulmonary bypass redesign. Perfusion. 2004 Jul;19(4):257-61. doi: 10.1191/0269216304pf749oa.

  PMID: 15376771 RESULT

• Groom RC, Quinn RD, Lennon P, Welch J, Kramer RS, Ross CS, Beaulieu PA, Brown JR, Malenka DJ, O'Connor GT, Likosky DS; Northern New England Cardiovascular Disease Study Group. Microemboli from cardiopulmonary bypass are associated with a serum marker of brain injury. J Extra Corpor Technol. 2010 Mar;42(1):40-4.

  PMID: 20437790 RESULT

• Groom RC, Quinn RD, Lennon P, Donegan DJ, Braxton JH, Kramer RS, Weldner PW, Russo L, Blank SD, Christie AA, Taenzer AH, Forest RJ, Clark C, Welch J, Ross CS, O'Connor GT, Likosky DS; Northern New England Cardiovascular Disease Study Group. Detection and elimination of microemboli related to cardiopulmonary bypass. Circ Cardiovasc Qual Outcomes. 2009 May;2(3):191-8. doi: 10.1161/CIRCOUTCOMES.108.803163. Epub 2009 May 5.

  PMID: 20031837 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum to study neurologic biomarker, Sb100.

MeSH Terms

Conditions

Cardiovascular Diseases; Intracranial Embolism; Hypotension

Condition Hierarchy (Ancestors)

Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Thromboembolism; Embolism and Thrombosis

Study Officials

• Donald S Likosky, Ph.D.

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

• David J. Malenka, MD

  Dartmouth-Hitchcock Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 7, 2007
• First Posted: February 8, 2007
• Study Start: October 1, 2002
• Primary Completion: August 1, 2011
• Study Completion: February 1, 2012
• Last Updated: May 16, 2013

Record last verified: 2013-05

Locations

US (3)