Protective Effect in Cardiac Surgery Patients

Fudan University

Status: Unknown

Conditions: Cardiac Surgery

Treatments: Drug: Ulinastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT04028024

B2019-156

Details and patient eligibility

About

The purpose of the study was to verify the protective effect of inhibiting systemic inflammatory response in patients undergoing cardiac surgery.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subject needs to have valve surgery
• subject needs to have coronary artery bypass grafting surgery
• subject needs to have artificial blood vessel replacement surgery
• ASA(American Society of Anesthesiologists) score II~III
• NYHA(New York Heart Association) II~III

Exclusion criteria

• LVEF(left ventricular ejection fraction) <40% measured by echocardiogram
• history of myocardial infarction within 1 month
• history of serious pulmonary infection or endocarditis within 3 months
• history of important surgery within 6 months

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

inhibiting systemic inflammatory response

Other group

Description:

Ulinastatin 5000U/kg in 20ml NS i.v. before occlusion of aorta

Treatment:

Drug: Ulinastatin