Does the use of Microplegia significantly improve outcomes in congenital heart surgery?

A comparison of short-term outcomes between two different cardiac arresting agents in congenital heart surgery: Microplegia Vs St Thomas II crystalloid cardioplegia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12983759

Enrollment

Registered

2016-06-21

Start date

2016-06-22

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital heart disease Circulatory System 1. Tetralogy of Fallot 2. Ventricular septal defect 3. Atrioventricular septal defects

Interventions

Patients will be randomised to receive either type of cardioplegia solutions, either Microplegia or St Thomas II crystalloid cardioplegia using envelope randomisation. For all participants, during su

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for elective corrective congenital heart surgery with either: 1.1. Tetralogy of Fallot 1.2. Ventricular septal defect 1.3. Atrioventricular septal defects 2. Weight 5-20kg

Exclusion criteria

Exclusion criteria: 1. Interstitial lung disease 2. Poor preoperative ventricular function EF < 50% 3. Inherent bleeding disorders (e.g. Di George Syndrome, Haemophiliacs, Von Willebrands ds) 4. More than 1 Cardiopulmonary bypass run, 5. Failure to separate from Cardiopulmonary bypass - Extracorporeal Membrane Oxygenation (ECMO), preoperative liver disease 6. Redo surgery

Design outcomes

Primary

Measure	Time frame
Lactate, haemoglobin and trophin I levels. The lactate and haemoglobin levels will be measured from arterial blood gases and the troponin I levels will be measured with iStat (Point of care) cartridges at baseline (preoperatively), intraoperatively (following the procedure), 6, 12 and 24 hours postoperatively.	—

Secondary

Measure	Time frame
1. Postoperative patient fluid balance is measured by recording the balance of fluid (ml) administered to patient and cardiopulmonary bypass machine intraoperatively (from the time the patient enters the operating theatre till the time the patient leaves theatre) against intraoperative fluid losses (urine output + cell-saved blood suctioned intraoperatively) 2. Need for inotropic support postoperatively is measured through use of a classification table immediately postoperatively and at 10am the following morning (one day postoperatively) 3. Need for ventilation postoperatively is measured by recording the number of days that the patient is kept intubated requiring ventilation 4. Systolic and diastolic ventricular function is assessed using echocardiography 2 days postoperatively	—

Measure

Time frame

1. Postoperative patient fluid balance is measured by recording the balance of fluid (ml) administered to patient and cardiopulmonary bypass machine intraoperatively (from the time the patient enters the operating theatre till the time the patient leaves theatre) against intraoperative fluid losses (urine output + cell-saved blood suctioned intraoperatively) 2. Need for inotropic support postoperatively is measured through use of a classification table immediately postoperatively and at 10am the following morning (one day postoperatively) 3. Need for ventilation postoperatively is measured by recording the number of days that the patient is kept intubated requiring ventilation 4. Systolic and diastolic ventricular function is assessed using echocardiography 2 days postoperatively

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Countries

South Africa

Contacts

Public ContactSharmel Bhika

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026