Cardiopulmonary bypass surgery Circulatory System Cardiopulmonary bypass surgery
Conditions
Interventions
A four-hour continuous intravenous (i.v.) infusion of Glypromate® 1 mg/kg/hr or placebo will be commenced on completion of protamine administration following cardiopulmonary bypass.
Sponsors
Neuren Pharmaceuticals Limited (New Zealand)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Scheduled for non-emergency CABG surgery and/or valve replacement/repair, with CPB 2. Willing to provide written informed consent 3. Able and agreeable to undergo all cognitive and Activities of Daily Living (ADL) testing (i.e. understands English, able to read, write, have sufficient motor dexterity and be available for follow-up visit at 4 - 6 weeks and 12 - 14 weeks post surgery) 4. Greater than or equal to 50 years old
Exclusion criteria
Exclusion criteria: 1. Pre-operative mechanical assist device or intra-aortic balloon pump inserted for shock or low output syndrome 2. Women of child-bearing potential or breastfeeding women 3. History of or any current condition that in the Investigator's opinion would interfere with study participation or evaluation of results 4. Congenital heart disease with a risk of polycythaemia, circulatory problems, or need for a shunt 5. Renal insufficiency (serum creatinine greater than 180 umol/L [greater than 2 mg/dL]) 6. Past or present bleeding disorder 7. History of organic brain syndrome 8. Currently receiving treatment for alcohol or drug abuse 9. Currently participating in another investigational drug or device study 10. Prior enrolment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study has co-primary endpoints measured by the composite Z score for cognition and the composite score for the ADL assessment. The primary analyses will compare effects of Glypromate® and placebo-based on the standardised composite cognitive change scores and the ADL scores. The total composite cognitive change score is calculated as the corrected directional sum of the changes in the five individual domain components plus three ancillary tests, i.e. the Pegboard Test, Stroop Test and Trail Making Test (adjusted for direction). The test battery comprises 12 tests, 9 from the Cognitive Drug Research's (CDR) computerised cognitive assessment system plus Trail Making Test (parts A & B), Stroop Test (congruent and incongruent), and Lafayette Grooved Regboard Test. The co-primary instrumental and physical ADL assessments used in this study are from the Older Americans Resources and Services (OARS) Multidimensional Functional Assessment Questionnaire, Centre for the Study of Aging and Human Development, Duke University. Primary outcome measures are collected at baseline (pre-surgery), 4 - 6 weeks post surgery and 12 - 14 weeks post surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Global evaluation of the patient's ability to perform activities of daily living (question 101 from the OARS Multidimensional Functional Questionnaire) 2. The incidence of stroke and Transient Ischaemic Attack (TIA) after CPB surgery 3. The change in cognitive domain (power of attention, continuity of attention, quality of working memory, quality of episodic memory, speed of memory) and individual cognitive test performance Secondary outcome measures are assessed at the same timepoints as per the primary measures and in addition an assessment is made on Day 2 post surgery for stroke and TIA. | — |
Countries
Australia, New Zealand, United States of America
Outcome results
None listed