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Myocardial protection with phosphocreatine in high-risk patients undergoing cardiac valvular surgery: a single-center randomised double-blind placebo-controlledexploratory pilot clinical trial

Myocardial protection with phosphocreatine in high-risk patients undergoing cardiac valvular surgery: a single-center randomised double-blind placebo-controlledexploratory pilot clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016141
Enrollment
Unknown
Registered
2018-05-14
Start date
2018-06-01
Completion date
Unknown
Last updated
2018-05-21

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

Conditions

heart disease

Interventions

phosphocreatine group:providing phosphocreatine
placebo group:providing placebo

Sponsors

CPB department, Fu Wai Hospital, Peking Union Medical College&Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Scheduled double/triple valve surgery; 2. Aged 18 years or older; 3. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Emergency surgery; 2. Concomitant coronary artery bypass grafting surgery or procedure on any part of the aorta; 3. Known allergy to phosphocreatine; 4. 60 Plan to radiofrequency ablation or cryogenic ablation; 5. Chronic kidney disease according to KDIGO criteria (at least one of the following present for > 3 months: glomerular filtration rate =60 ml/min/1.73 m2, history of kidney transplantation); 6. Pregnancy; 7. Current enrollment into another randomised controlled study (in the last 30 days); 8. Previous enrollment and randomisation into the PRISE trial; 9. Administration of phosphocreatine in previous 30 day.

Design outcomes

Primary

MeasureTime frame
TnI;NT-pro BNP;CK\CK-MB;

Secondary

MeasureTime frame
Left ventricular ejection fraction;Cardiac index;inotropic agents;4. The need for (yes/no), the number of and the dosage of, defibrillation after aortic declamping;sCr;BIG-ET;MYO;

Countries

China

Contacts

Public ContactGao Guodong
gaoguodongfw@163.com+86 13520106867

Outcome results

None listed

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