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Randomized controlled trial for efficacy and safety evaluation of postoperative caloric on-demand vs caloric fixed dose in complex congenital heart disease children

Randomized controlled trial for efficacy and safety evaluation of postoperative caloric on-demand vs caloric fixed dose in complex congenital heart disease children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17012408
Enrollment
Unknown
Registered
2017-08-18
Start date
2017-09-01
Completion date
Unknown
Last updated
2017-08-21

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

Conditions

Complex congenital heart disease

Interventions

Caloric on-demand group:Measurement of REE by indirect calorimetry to on-demand of calorie
Caloric fixed dose group:intake standardized calorie (1.4g/100mL, 67kcal/100mL)

Sponsors

Guangzhou Women and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Complex congenital heart disease with concurrent cardiopulmonary bypass; 2. Aged 1 to 12 months; 3. Intensive care unit (ICU) for at least 5 days after operation.

Exclusion criteria

Exclusion criteria: 1. Alimentary tract malformation, inherited metabolic diseases, chromosomal disorder; 2. Abnormal liver and kidney function before ICU admission (>2 times of normal value); 3. Active upper GI bleeding or vomiting, diarrhea, virtuosity before ICU admission; 4. Coarctation of the aorta (COA) or Interruption of aortic arch (IAA).

Design outcomes

Primary

MeasureTime frame
nitrogen balance;Clinical Indicator;—

Secondary

MeasureTime frame
Biochemical Indicator;Tolerance Indicator;Milk yield Indicator;—

Countries

China

Contacts

Public ContactYanqing Cui

Guangzhou Women and Children's Medical Center

litcelerychui@163.com+86 18902268662

Outcome results

None listed

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