Protective Effect in Cardiac Surgery Patients

• Sponsor: Shanghai Zhongshan Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04028024
• Collaborator: (none)
• Enrollment: 90
• Arm: 1
• Anticipated Duration (Months): 22

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery	Drug: Ulinastatin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Study on the Protective Effect of Inhibiting Systemic Inflammatory Response in Patients Undergoing Cardiac Surgery.
• Anticipated Study Start Date: Aug 1, 2019
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: inhibiting systemic inflammatory response Ulinastatin 5000U/kg in 20ml NS i.v. before occlusion of aorta	Drug: Ulinastatin; Ulinastatin 5000U/Kg in 20 ml NS i.v. before occlusion of aorta

Outcome Measures

Primary Outcome Measures

1. postoperative delirium [7 days postoperatively or discharge, whichever came first]

   the incidence of postoperative delirium

2. postoperative renal insufficiency [7 days postoperatively or discharge, whichever came first]

   the incidence of renal insufficiency

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai Zhongshan Hospital

Investigators

• Principal Investigator: Hui-lin Wang, Phd, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT04028024
• Other Study ID Numbers: B2019-156
• First Posted: Jul 22, 2019
• Last Update Posted: Jul 22, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinastatin

Study Results

No Results Posted as of Jul 22, 2019