Protective Effect in Cardiac Surgery Patients | NCT04028024

Studies
Protective Effect in Cardiac Surgery Patients

NCT04028024

Sponsor

Shanghai Zhongshan Hospital

Status

Unknown status

Last Update Posted

Jul 22, 2019Actual

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Cardiac Surgery

Interventions

Ulinastatin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2019Estimated

Primary Completion Date

Dec 2020Estimated

Completion Date

Jun 2021Estimated

First Submitted Date

Jul 14, 2019

First Submission Date that Met QC Criteria

Jul 19, 2019

First Posted Date

Jul 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2019

Last Update Posted Date

Jul 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
inhibiting systemic inflammatory response	Other	Ulinastatin 5000U/kg in 20ml NS i.v. before occlusion of aorta	Drug: Ulinastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ulinastatin	Drug	Ulinastatin 5000U/Kg in 20 ml NS i.v. before occlusion of aorta	inhibiting systemic inflammatory response

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ke-fang Guo, PhD	Contact	64041990		Guo.kefang@zs-hospital.sh.cn

Overall Officials

Name	Affiliation	Role
Hui-lin Wang, Phd	Fudan University	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C028665	urinastatin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided