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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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2 September 2019 |
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Main ID: |
ChiCTR1900025513 |
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Date of registration:
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2019-08-31 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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2019-09-01 |
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Target sample size:
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01:8;02:8;03:8;04:8;05:8; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=41381 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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0
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Countries of recruitment
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China
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Contacts
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Name:
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Zhang Hao
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Address:
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1678 Dongfang Road, Shanghai
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Telephone:
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+86 13301191791 |
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Email:
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drzhanghao@126.com |
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Affiliation:
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Shanghai Children's Medical Center |
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Name:
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Fan Taibing
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Address:
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1 Fuwai Avenue, Zhengdong New District, Zhengzhou, Henan, China
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Telephone:
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+86 15038078538 |
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Email:
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fantaibing@163.com |
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Affiliation:
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Pediatric Cardiac Surgery, Fuwai Central China Cardiovascualr Hospital |
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Key inclusion & exclusion criteria
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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: 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.
Age minimum:
0
Age maximum:
2
Gender:
Both
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Health Condition(s) or Problem(s) studied
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tetralogy of fallot (pulmonary atresia)
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Intervention(s)
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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.;
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Primary Outcome(s)
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Cardiac troponin T;
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Secondary Outcome(s)
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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;
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Source(s) of Monetary Support
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National Science Fund for Distinguished Young Scholars
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Ethics review
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Status: Approved
Approval date: 18/07/2019
Contact:
fantaibing@163.com
Fan Taibing
+86 15038078538
fantaibing@163.com
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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