Protective Effect in Cardiac Surgery Patients

July 19, 2019 updated by: Shanghai Zhongshan Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative delirium
Time Frame: 7 days postoperatively or discharge, whichever came first
the incidence of postoperative delirium
7 days postoperatively or discharge, whichever came first
postoperative renal insufficiency
Time Frame: 7 days postoperatively or discharge, whichever came first
the incidence of renal insufficiency
7 days postoperatively or discharge, whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2019

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

July 14, 2019

First Submitted That Met QC Criteria

July 19, 2019

First Posted (ACTUAL)

July 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2019

Last Update Submitted That Met QC Criteria

July 19, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2019-156

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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