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Protective Effect in Cardiac Surgery Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04028024
Enrollment
90
Registered
2019-07-22
Start date
2019-08-01
Completion date
2021-06-30
Last updated
2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Brief summary

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

Interventions

DRUGUlinastatin

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

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
postoperative delirium7 days postoperatively or discharge, whichever came firstthe incidence of postoperative delirium
postoperative renal insufficiency7 days postoperatively or discharge, whichever came firstthe incidence of renal insufficiency

Contacts

Primary ContactKe-fang Guo, PhD
Guo.kefang@zs-hospital.sh.cn64041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026