A RANDOMISED CONTROLLED TRIAL TO COMPARE NORMOXIC VERSUS STANDARD CARDIOPULMONARY BYPASS IN CYANOTIC CHILDREN UNDERGOING CARDIAC SURGERY - Oxic-2

Phase 1

Active, not recruiting

Conditions: The study investigates reoxygenation injury in cyanotic paediatric patients undergoing on-pump cardiac surgery. The types of heart condition being investigated result in chronic low blood oxygen saturation, causing cyanosis.
MedDRA version: 12.1Level: HLTClassification code 10010395Term: Congenital cardiac malpositions and transpositions
MedDRA version: 12.1Level: HLTClassification code 10010397Term: Congenital cardiac structural defects NEC
MedDRA version: 12.1Level: LLTClassification code 10010396Term: Congenital cardiac septal defect NOS
MedDRA version: 12.1Level: LLTClassification code 10062326Term: Congenital cardiac septal defect

Registration Number: EUCTR2010-019713-21-GB

Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

1.Cyanotic children (SaO2 = 92%) undergoing operations to repair a heart defect
2.Children aged = 1 month of age
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Preoperative diagnosis of Down’s syndrome or other developmental disorders (for the assessment of developmental outcomes)
2.Emergency operations
3.Neonatal patients (<1 month old).
4.Patients undergoing SWITCH procedures

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the trial is to assess the clinical health effects of controlling reoxygenation during cariopulmonary bypass in cyanotic paediatric patients undergoing cardiac surgery. <br><br>The primary measure of this is 'clinical outcome', defined in particular by duration of inotropic support, intubation time, time in ICU and length of postoperative stay.;Secondary Objective: The secondary objectives are to investigate the effects of controlling reoxygenation on the following factors:<br><br>1 - In-hospital mortality and morbidity<br>2 - Developmental neurocognitive measures<br>3 - Brain injury <br>4 - Renal function<br>5 - Gene expression profiles in myocardial DNA<br>6 - Myocardial cell contractility<br>7 - School entry test results (with parental permission);Primary end point(s): Clinical outcome, in particular duration of inotropic support, intubation time, ICU and postoperative stay is the primary outcome.

Secondary Outcome Measures