Sodium Creatine Phosphate in Heart Valve Surgery

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Unknown

Conditions: Heart Valve Diseases

Treatments: Drug: sodium creatine phosphate; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03186053

FWT2017-ZX004

Details and patient eligibility

About

To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery

Full description

Objective: To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery Methods: 250 patients undergoing valve surgery were randomly divided into experimental group and control group. 5g creatine phosphate was dissolved in 50ml saline solution. After induction of anesthesia, the patients were first given a load dose of 1g, 20min (30ml / h) , And then pumped at a rate of 1 g / h (10 ml / h). The control group was treated with saline in the same manner. The cTnI level was measured at the corresponding time points. Hemodynamic indexes and postoperative complications were recorded.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass(CPB)

Exclusion criteria

• thoracoscopic valve surgery
• other organ dysfunction: such as cancer, organ failure, severe anemia, infection
• patients with mental disorders
• coagulopathy, active ulcer, ischemic or hemorrhagic stroke (within 6 months), trauma

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups, including a placebo group

sodium creatine phosphate

Experimental group

Description:

5g creatine phosphate was dissolved in 50ml saline solution. After induction of anesthesia, the patients were first given a load dose of 1g, 20min (30ml / h) , And then pumped at a rate of 1 g / h (10 ml / h).

Treatment:

Drug: sodium creatine phosphate

Control

Placebo Comparator group

Description:

The control group was treated with saline in the same manner.

Treatment:

Drug: saline