Protective Effect in Cardiac Surgery Patients

Not Applicable

• Conditions: Cardiac Surgery
• Interventions: Drug: Ulinastatin

• Registration Number: NCT04028024
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-14
• Study First Submitted QC: 2019-07-19
• Last Update Submitted: 2019-07-19
• Study First Posted: 2019-07-22
• Last Update Posted: 2019-07-22
• Study Start: 2019-08-01
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
inhibiting systemic inflammatory response	Ulinastatin	Ulinastatin 5000U/kg in 20ml NS i.v. before occlusion of aorta

Primary Outcome Measures

Name	Time	Method
postoperative delirium	7 days postoperatively or discharge, whichever came first	the incidence of postoperative delirium
postoperative renal insufficiency	7 days postoperatively or discharge, whichever came first	the incidence of renal insufficiency