The Cardio-protective Effect of Cardiomyopeptidin on Myocardial Injury in ICU Patients With Non-organic Heart Disease: a Prospective, Single-blind, Randomized Controlled Pilot Study

Nanfang Hospital, Southern Medical University

Status and phase: Completed; Phase 4

Conditions: ICU; Myocardial Injury

Treatments: Drug: 50 ml of normal saline intravenous infusion; Drug: Cardiopeptidin

Study type: Interventional

Funder types: Other

Identifiers

NCT06117046

NFEC-2023-060

Details and patient eligibility

About

The study was a single-center, randomized controlled pilot study. To explore the cardioprotective effect of cardiopeptidin on non-heart disease patients with severe cardiac injury by comparing whether cardiopeptidin was used.

Enrollment: 234 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years old
2. The high-sensitive troponin T index was higher than the normal value during ICU hospitalization
3. Obtain the informed consent of the subject or legal agent

Exclusion criteria

1. Patients who are expected to die within 48 hours of ICU admission
2. previous diagnosis of acute coronary syndrome, chronic cardiomyopathy, pulmonary heart disease, acute myocarditis, pericardial tamponade and other diseases that have been confirmed to cause myocardial injury
3. cardiopulmonary resuscitation and/or electrical defibrillation before admission
4. patients with acute ischemic stroke
5. patients with stage 5 chronic kidney disease
6. during pregnancy or breastfeeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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234 participants in 2 patient groups, including a placebo group

Cardiopeptidin

Experimental group

Description:

Cardiopeptidin was administered intravenously once a day with 60mg of cardiopeptide for 3 days

Treatment:

Drug: Cardiopeptidin

50 ml of normal saline intravenous infusion

Placebo Comparator group

Description:

50 ml of normal saline intravenous infusion.

Treatment:

Drug: 50 ml of normal saline intravenous infusion