Protective Effect in Cardiac Surgery Patients

Cardiac Surgery Clinical Trial

Official title:

Study on the Protective Effect of Inhibiting Systemic Inflammatory Response in Patients Undergoing Cardiac Surgery.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04028024
• Other study ID #: B2019-156
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: June 2021

Study information

• Verified date: July 2019
• Source: Shanghai Zhongshan Hospital
• Contact: Ke-fang Guo, PhD
• Phone: 64041990
• Email: Guo.kefang[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Drug:
• Ulinastatin
Ulinastatin 5000U/Kg in 20 ml NS i.v. before occlusion of aorta

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative delirium	the incidence of postoperative delirium	7 days postoperatively or discharge, whichever came first
Primary	postoperative renal insufficiency	the incidence of renal insufficiency	7 days postoperatively or discharge, whichever came first