NCT04028024

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

1.3 years

First QC Date

July 14, 2019

Last Update Submit

July 19, 2019

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

inhibiting systemic inflammatory response

OTHER

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

Drug: Ulinastatin

Interventions

UlinastatinDRUG

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

inhibiting systemic inflammatory response

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

urinastatin

Study Officials

  • Hui-lin Wang, Phd

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke-fang Guo, PhD

CONTACT

64041990Guo.kefang@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2019

First Posted

July 22, 2019

Study Start

August 1, 2019

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

July 22, 2019

Record last verified: 2019-07