Cardiopulmonary bypass procedure Surgery Cardiopulmonary bypass
Conditions
Interventions
The hypothermic group will have their blood cooled to 28°C during CPB (standard practice). The normothermic group will have their blood temperature maintained at 35 - 37°C during CPB.
Sponsors
University Hospitals Bristol NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 15/05/2015: Participant may enter study if ALL of the following apply: 1. Patients undergoing congenital heart operations not requiring deep hypothermic circulatory arrest 2. Patients aged =17 years of age Previous inclusion criteria: 1. Female and male patients from birth upwards (there is no upper age limit, per se) 2. Treated at the Bristol Royal Hospital for Children 3. Undergoing congenital heart operations not requiring deep hypothermic circulatory arrest
Exclusion criteria
Exclusion criteria: Participant may not enter study if ANY of the following apply 1. Emergency operations (patients with haemodynamic instability who require immediate surgical intervention) 2. Patients requiring hypothermic circulatory arrest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 15/05/2015: Clinical outcome, in particular: 1. Duration of inotropic support 2. Intubation time 3. Postoperative hospital stay (from date of surgery to discharge from cardiac ward) Previous primary outcome measures: Clinical outcome, in particular duration of inotropic support, intubation time and post-operative stay. Measured in the period of post-operative hospitalisation, estimated to be 6 days on average. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 15/05/2015: 1. In-hospital mortality and morbidity. 2. Blood loss and transfusion requirements. 3. Pre-operative and post-operative echocardiographic (ECG) findings. 4. Routine blood gas and blood test results. 5. Renal function as measured by urinary albumin, urinary creatinine, retinal binding protein (RBP), N-acetyl-ß-glucosaminidase (NAG) and neutrophil gelatinase-associated lipocalin (NGAL). All markers of renal damage will be measured pre-operatively, and at several time-points post-operatively. 6. Cerebral function as measured by Glial Fibrillary Acidic Protein (GFAP), a serum marker of traumatic brain injury. GFAP levels will be measured of GFAP pre-operatively and at several time-points mid- and post-operatively. 7. Regional oxygen saturation of blood in the cerebral cortex, measured at approximately 15-minute intervals during the operative period using Near Infra-Red Spectroscopy (NIRS). 8. Neuropsychological development, assessed using the NEPSY-II psychometric tool. Neuropsychological assessments will be performed on patients aged between 3-16 years, pre-operatively and at 3- and 12-months post-operatively. These tests are intended as a tool to allow the assessment of both basic and complex aspects of cognition across six functional domains: attention and executive functions, language, memory and learning, sensorimotor functions, social perception and visual-spatial processing. 9. Cardiac tissue biopsies from heart tissue discarded during the surgical procedure and considered clinical waste will be analysed for biochemical markers and RNA analysis on a subset of 32 patients. If available, four samples will be collected from each patient in this subset; two samples will be collected immediately after institution of CPB and a further two samples 10-15 minutes after reperfusi | — |
Countries
United Kingdom
Outcome results
None listed