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Population pharmacokinetics of creatine phosphate sodium for injection in children with infective myocarditis

Population pharmacokinetics of creatine phosphate sodium for injection in children with infective myocarditis

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-17014034
Enrollment
Unknown
Registered
2017-12-19
Start date
2017-12-29
Completion date
Unknown
Last updated
2018-01-29

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

Conditions

Infective myocarditis

Interventions

28day~ < 1 year old:0.5 g IV BID
1~ < 6 years old :1.0 g IV BID
6~ < 18 years old:2.0 g IV BID

Sponsors

Beijing Children's Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients (under 18 years old) with infective myocarditis; 2. Patients diagnosed as infective myocarditis (according with 2 of diagnostic criteria): (1) cardiac dysfunction, cardiac shock or cardio-cerebral syndrome; (2) cardiac dilatation (according to X-ray or echocardiography examination); (3) ECG changes: ST-T changes of 2 or more major leads (I, II, aVF, V5) dominated by R wave last more than 4 days accompanied by dynamic changes, sinoatrial block, Ventricular block, completely right or left bundle branch block, into the law, polymorphism, multi-source, paired or parallel premature beats, non-atrioventricular node and atrioventricular reentrant-induced atopic tachycardia, low Voltage (except for newborns) and abnormal Q waves; (4) elevated CK-MB or positive result for cardiac troponin (cTnI or cTnT); 3. Patients with acute stage of the myocarditis clinical staging; 4. All the subjects or their guardians must sign the consent form before entering the trial.

Exclusion criteria

Exclusion criteria: 1. Patients with fulminant myocarditis (diagnostic criteria refer to September 1999 Kunming National Pediatric myocarditis, cardiomyopathy conference developed diagnostic criteria of children with viral myocarditis (drafted version), which is that the disease is extremely rapid developed, in a few hours or 1-2 Days that occurred acute cardiac insufficiency or cardiogenic shock, excluding other causes of secondary changes, diagnosis of fulminant myocarditis); 2. Patients with myocardial damage caused by rheumatic myocarditis, toxic myocarditis, congenital heart disease, connective tissue disease or metabolic diseases, hyperthyroidism, primary cardiomyopathy, primary endocardial fibroelastosis, congenital atrioventricular block, cardiac autonomic dysfunction, ß receptor hyperactivity or drug-induced ECG changes; 3. Patients currently with other serious and unstable physical illnesses including cardiovascular, liver, kidney, gastrointestinal, respiratory, endocrine, neurological, immune system, blood system, epilepsy, and other diseases that may interfere with clinical trial results or that increase patients' risks; 4. Patients with myocardial injury caused by other reasons; 5. Patients with heart disease history or complications; 6. Patients who are allergic to creatine phosphate; 7. Patients with allergic constitution, or who was allergy to any food or require for special diet, or allergy to the routine medication and associated drug in this study; 8. Patients who participated in any other clinical trial within 3 months before baseline; 9. Patients with other serious infectious diseases during screening period; 10. Subjects who may not be able to complete the study for other reasons; 11. Patients who has uncured dehydration, acidosis, hypotension, renal disorder, or are using drugs with nephrotoxicity; 12. Patients with other conditions that are not suitable for enrollment according to the researcher's standard.

Design outcomes

Primary

MeasureTime frame
ECG;Myocardial enzymes;Echocardiography;

Secondary

MeasureTime frame
Clinical symptoms and signs;

Countries

China

Contacts

Public ContactYue Yuan, Xiaoling Wang

Beijing Children's Hospital, Capital Medical University

yuanyuebj22@sina.com+86 010-59616380

Outcome results

None listed

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