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A Randomized Controlled Trial of Thyroid Hormone Replacement Therapy in Children with Euthyroid Sick Syndrome Following Congenital Heart Disease Surgery with Cardiopulmonary Bypass

A Randomized Controlled Trial of Thyroid Hormone Replacement Therapy in Children with Euthyroid Sick Syndrome Following Congenital Heart Disease Surgery with Cardiopulmonary Bypass

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093391
Enrollment
Unknown
Registered
2024-12-03
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Euthyroid Sick Syndrome

Interventions

thyroid hormone replacement therapy group:Oral administration of 5 ug/kg/day of thyroid hormone tablets 24h postoperatively for 5 consecutive days
Placebo-Controlled Group:Oral administration of a placebo (milk tablets of the same appearance) 24h postoperatively for 5 consecutive days

Sponsors

Children's Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: (1) Children under one year of age, both genders are eligible; (2) Diagnosed with congenital heart disease requiring surgery under extracorporeal circulation, can be combined with pulmonary arterial hypertension or valvular regurgitation; (3) Preoperative thyroid hormone levels are normal, ultrasound shows no organic lesions, no thyroid tablets were taken preoperatively, and postoperatively developed Euthyroid Sick Syndrome (ESS) in children; (4) The guardians of the child understand the nature of this trial and agree to participate, voluntarily sign the informed consent form approved by the ethics committee, and agree to accept the postoperative treatment plan and follow-up requirements.

Exclusion criteria

Exclusion criteria: (1) The disease suffered by the patient will cause difficulties in evaluation (such as malignant tumors, chromosomal abnormalities, airway deformities, renal dysfunction, gastrointestinal deformities, severe metabolic diseases, etc.); (2) Preoperative myocardial dysfunction, acidosis, shock, etc.; (3) Death within 24 hours postoperatively or during the surgery; (4) Postoperative extracorporeal membrane oxygenation (ECMO) support; (5) History of previous cardiac surgery; (6) The researcher judges that the patient's compliance is poor and cannot complete the study as required (including but not limited to those with obvious mental disorders, epilepsy patients, and others who are unable to act or have cognitive abilities); (7) Social assistance personnel and non-Chinese citizens.

Design outcomes

Primary

MeasureTime frame
Postoperative left ventricular ejection fraction;the length of hospitalization;

Secondary

MeasureTime frame
Vasoactive-inotropic score;mechanical ventilation time;length of CCU stay;Whether Low Cardiac Output Syndrome (LCOS) occurs;whether Compartmental Fluid Accumulation occurs;In-hospital mortality ;

Countries

China

Contacts

Public ContactZou Liang; Mo Xuming

Department of Cardiothoracic Surgery, Children's Hospital of Nanjing Medical University

mohsuming15@njmu.edu.cn+86 189 5176 9006

Outcome results

None listed

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