Protective Effect in Cardiac Surgery Patients

NCT ID: NCT04028024

Last Updated: 2019-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-06-30

Brief Summary

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

Detailed Description

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Conditions

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Cardiac Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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inhibiting systemic inflammatory response

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

Group Type OTHER

Ulinastatin

Intervention Type DRUG

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

Interventions

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Ulinastatin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hui-lin Wang, Phd

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Central Contacts

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Ke-fang Guo, PhD

Role: CONTACT

Other Identifiers

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B2019-156

Identifier Type: -

Identifier Source: org_study_id

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