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The safety and efficacy of preoperative oral supplementation of coenzyme Q10 in improving postoperative cardiac function in children with tetralogy of fallot (pulmonary atresia): a preliminary study

The safety and efficacy of preoperative oral supplementation of coenzyme Q10 in improving postoperative cardiac function in children with tetralogy of fallot (pulmonary atresia): a preliminary study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025513
Enrollment
Unknown
Registered
2019-08-31
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-09-02

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

Conditions

tetralogy of fallot (pulmonary atresia)

Interventions

01:N/A
02:Oral coenzyme Q10, 2.5mg, t.i.d.
03:Oral coenzyme Q10, 5mg, t.i.d.
04:Oral coenzyme Q10, 10mg, t.i.d.
05:Oral coenzyme Q10, 20mg, t.i.d.

Sponsors

Fuwai Central China Cardiovascualr Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 2 Years

Inclusion criteria

Inclusion criteria: Patients with tetralogy of fallot or pulmonary atresia undergoing radical surgery in the children's heart center of fuwai central China cardiovascular hospital Weight<15kg Multiple resting oxygen saturation measurements < 85%

Exclusion criteria

Exclusion criteria: 1. History of previous cardiac surgery; 2. Chromosomal abnormalities; 3. Respiratory diseases; 4. Immunodeficiency disease; 5. Gastrointestinal diseases that affect coenzyme Q10 absorption 6. Preoperative positive inotropic drugs or circulation aids support; 7. Take Coenzyme Q10 2 weeks before admission; 8. Other antioxidants (vitamin C, E, A) and myocardial protectors were taken 2 weeks before admission 9. Participated in other clinical trials in the last 3 months; 10. Take warfarin 2 weeks before admission.

Design outcomes

Primary

MeasureTime frame
Cardiac troponin T;

Secondary

MeasureTime frame
Cardiac troponin T;CK-MB;IL-6;inotropic score;left ventricular ejection fraction;left ventricular end-systolic diameter,;left ventricular end-diastolic diameter;fractional shortening;ICU stay time;Mechanical ventilation time, from aortic cross-clamp release to extubation;Postoperative hospitalization time;postoperative complications;in-hospital mortality;Plasma coenzyme Q10;

Countries

China

Contacts

Public ContactFan Taibing

Pediatric Cardiac Surgery, Fuwai Central China Cardiovascualr Hospital

fantaibing@163.com+86 15038078538

Outcome results

None listed

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