Children with a congenital heart defect which results in cyanosis and which are amenable to surgical repair Surgery Congenital malformations of cardiac chambers and connections
Conditions
Interventions
All children will undergo surgery for repair of congenital cyanotic heart disease. All operations will be performed using cardiopulmonary bypass (CPB) with ascending aortic cannulation and bicaval ven
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 08/03/2013: 1. Cyanotic children undergoing operations to repair or palliate a heart defect 2. Children must be =1 month old to be eligible for all the neurocognitive assessments. Children = 1 month of age Previous inclusion criteria until 26/07/2012: 1. Cyanotic children (both males and females) undergoing operations to repair a heart defect 2. Children aged >= 1 month of age
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 08/03/2013: 1. Children with a preoperative diagnosis of Down?s syndrome or other developmental disorders are excluded from the neurocognitive assessments as part of the trial, but may be included in the main study 2. Emergency operations 3. Children requiring cardiovascular and/or respiratory support prior to study entry Previous exclusion criteria until 08/03/2013: 1. Children with a preoperative diagnosis of Down's syndrome or other developmental disorders are excluded from the neurocognitive assessments as part of the trial, but may be included in the main study 2. Emergency operations 3. Patients undergoing arterial switch procedure 4. Neonatal patients (<1 month old) Previous exclusion criteria as of 26/07/2012: 1. Preoperative diagnosis of Down's syndrome or other developmental disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical outcomes: 1. Duration of inotropic support 2. Intubation time 3. Length of intensive care unit (ICU) stay 4. Length of hospital stay | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. In-hospital mortality and morbidity (e.g., blood loss, transfusion requirement, abnormal echocardiographic findings, abnormal post-operative blood test results) 2. Developmental assessments using the Bayley III Infant Development Scales measured pre-operatively and at 3 and 12 months after surgery (children aged up to 42 months only) 3. Assessment of brain injury using a biochemical marker (astroglial S100) measured pre-operatively, 10 and 30 minutes after starting CPB, 10 minutes after the end of surgery, and 4 and 24 hours after surgery 4. Renal function, measured by plasma creatinine and urea nitrogen levels taken every 24 hours for the first 5 days after surgery 6. Gene expression profiles associated with rexoygenation injury to the heart muscle | — |
Countries
United Kingdom
Outcome results
None listed