Investigating the effect of adequate energy and protein intake for children after cardiopulmonary bypass surgery

Early enteral nutrition of adequate energy and protein intakes to meet requirements in children after cardiopulmonary bypass: An international, multicenter, randomized, controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10130540

Enrollment

2500

Registered

2020-09-10

Start date

2021-01-01

Completion date

Unknown

Last updated

2020-09-28

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

Conditions

Congenital heart disease Neonatal Diseases Congenital malformations of the circulatory system

Interventions

Participants will be randomly allocated in a 1:1 ratio to either the control or intervention group using a block randomization method where participants will be stratified into 4 sets of blocks accord

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of congenital heart disease and planned cardiopulmonary bypass 2. Aged between 1 month and 1 year 3. Informed consent given by parent(s) or legal guardian 4. Gestational age at birth >36 weeks.

Exclusion criteria

Exclusion criteria: 1. Any major congenital abnormality such as congenital diaphragmatic hernia or tracheoesophageal fistula 2. Acquired extra-cardiac disorder that could independently affect the primary endpoint such as meconium aspiration with a need for high-frequency ventilation, persistent renal failure requiring dialysis, chylothorax and gastrointestinal necrosis, or postoperative use of steroids in ICU

Design outcomes

Primary

Measure	Time frame
1. New infections acquired during the Cardiac Intensive Care Unit (CICU) stay and the duration of antibiotic treatment assessed using patient notes at the time of CICU discharge 2. The duration of CICU dependency assessed using patient notes at the time of CICU discharge	—

Secondary

Measure	Time frame
1. Mortality: 1.1. During the first 7 days in the CICU assessed using patient notes at the time of CICU discharge. 1.2. During the total stay in the CICU assessed using patient notes at the time of CICU discharge. 1.3. During the total stay in the hospital assessed using patient notes at the time of hospital discharge. 1.4. At 30 days after admission to the CICU and randomization assessed using investigator records at 30 days after surgery. 1.5. The rates of survival up to 90 days, regardless of ICU and hospital discharge status assessed using investigator records at 90 days after surgery. 1.6. The proportion of patients who were alive 8 days after CICU discharge assessed using investigator records at 8 days after CICU discharge. 2. The number of readmissions to CICU within 48 h assessed using investigator records at 48 h after CICU discharge 3. The time to final (live) weaning from mechanical ventilatory support assessed using investigator records at the time of weaning 4. The time to (live) discharge from the hospital assessed using investigator records at the time of hospital discharge 5. The need for cardiovascular support assessed using the duration of pharmacologic or mechanical hemodynamic support and Vasoactive-Inotropic Score (VIS) assessed using patient notes at the time of CICU discharge 6. The rate of organ dysfunction: 6.1. Renal dysfunction: 6.1.1. Acute kidney injury defined as at least a doubling of the serum creatinine level recorded on admission, measured through blood samples taken at baseline and every CICU day. 6.1.2. Proportion of patients requiring renal replacement therapy, and the duration of such therapy in the ICU, assessed using patient notes after CICU discharge. 6.2. Liver dysfunction	—

Measure

Time frame

1. Mortality: 1.1. During the first 7 days in the CICU assessed using patient notes at the time of CICU discharge. 1.2. During the total stay in the CICU assessed using patient notes at the time of CICU discharge. 1.3. During the total stay in the hospital assessed using patient notes at the time of hospital discharge. 1.4. At 30 days after admission to the CICU and randomization assessed using investigator records at 30 days after surgery. 1.5. The rates of survival up to 90 days, regardless of ICU and hospital discharge status assessed using investigator records at 90 days after surgery. 1.6. The proportion of patients who were alive 8 days after CICU discharge assessed using investigator records at 8 days after CICU discharge. 2. The number of readmissions to CICU within 48 h assessed using investigator records at 48 h after CICU discharge 3. The time to final (live) weaning from mechanical ventilatory support assessed using investigator records at the time of weaning 4. The time to (live) discharge from the hospital assessed using investigator records at the time of hospital discharge 5. The need for cardiovascular support assessed using the duration of pharmacologic or mechanical hemodynamic support and Vasoactive-Inotropic Score (VIS) assessed using patient notes at the time of CICU discharge 6. The rate of organ dysfunction: 6.1. Renal dysfunction: 6.1.1. Acute kidney injury defined as at least a doubling of the serum creatinine level recorded on admission, measured through blood samples taken at baseline and every CICU day. 6.1.2. Proportion of patients requiring renal replacement therapy, and the duration of such therapy in the ICU, assessed using patient notes after CICU discharge. 6.2. Liver dysfunction

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Countries

Australia, China

Outcome results

None listed

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