Ulinastatin Improves and Prevents Cardiac Dysfunction Induced by Cardiopulmonary Bypass

NCT05534802 | Completed DMC

• 1 other identifier: TJ-IRB20220831
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

This project explores the role and mechanism of ulinastatin in preventing cardiac dysfunction caused by cardiopulmonary bypass by reducing cardiac endothelial permeability through clinical research. Our previous basic research has found that inhibiting the TK/B1R/ARNT/MMP3/iNOS signaling axis in the acute phase of cardiac R/I can reduce the permeability of cardiac endothelial cells, reduce cardiac edema and improve cardiac function (this part has been completed) . This study intends to investigate the effects of ulinastatin on 24-hour cardiac function and prognosis in patients undergoing cardiac surgery undergoing cardiopulmonary bypass (cardiac function, inflammatory indicators, coagulation function, capillary leakage indicators, 28-day survival time, CCU time). At the same time, we observed the dynamic changes of TK/B1R/MMP3 during cardiopulmonary bypass in patients undergoing cardiac surgery and explored its relationship with prognosis, as well as the effect of ulinastatin intervention on TK/B1R/MMP3 before and after cardiopulmonary bypass.

Conditions

Pharmacological Action

Keywords

Cardiac Dysfunction; Cardiac endothelial permeability

Outcome Measures

Primary Outcomes (5)

• Cardiac function

  Echocardiographic detection

  24 hours

• Inflammatory marker

  Detection of CRP

  24 hours

• Inflammatory markers

  Detection of IL6

  24 hours

• TK/B1R/MMP3 signaling

  Detection levels of tissue kallikrein, B1R and MMP3

  24 hours

• POD-postoperative delirium

  Assessment Method for the ICU (CAM-ICU

  7 days

Secondary Outcomes (1)

• Survival time

  28 days

Study Arms (2)

Conventional treatment group

SHAM COMPARATOR

Cardiac surgery patients undergoing cardiopulmonary bypass are not treated with ulinastatin

Other: saline

Ulinastatin

EXPERIMENTAL

Cardiac surgery patients undergoing cardiopulmonary bypass are treated with ulinastatin

Drug: Ulinastatin

Interventions

Ulinastatin DRUG

On the basis of conventional treatment, according to the instructions or previous research doses (general anesthesia and tracheal intubation, after cardiopulmonary bypass transfer starts): 10,000 U/kg Ulinastatin (National Medicine Approval No. H19990134, Guangdong Tianpu Biochemical Pharmaceutical Co., Ltd. Co., Ltd., Guangzhou, China) was dissolved in 50 ml of normal saline for 1 hour and pumped through the central vein.

Ulinastatin

saline OTHER

On the basis of conventional treatment, 50 ml of normal saline for 1 hour and pumped through the central vein.

Conventional treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent;
• Age ≥18 years old and ≤70 years old;
• Patients receiving cardiopulmonary bypass
• Patients undergoing heart valve replacement surgery, major vascular surgery, and other cardiac surgery

You may not qualify if:

• Severe cardiac insufficiency before surgery (EF\<50%, cardiogenic shock);
• Patients with adverse events during surgery (such as cardiac arrest, etc.);
• Solid organ or bone marrow transplant recipients;
• pregnant women;
• Have a history of allergy to ulinastatin or any of its ingredients;
• Suffering from autoimmune diseases, tumors, or received high-dose hormones, immunosuppressive drugs, etc. within 2 months;
• The researcher judges that it is not suitable to participate in this research.

Sponsors & Collaborators

• Qin Zhang: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Related Publications (3)

• Liu Y, Wang YL, Zou SH, Sun PF, Zhao Q. Effect of high-dose ulinastatin on the cardiopulmonary bypass-induced inflammatory response in patients undergoing open-heart surgery. Chin Med J (Engl). 2020 Jun 20;133(12):1476-1478. doi: 10.1097/CM9.0000000000000832. No abstract available.

  PMID: 32496303 RESULT

• Atal SS, Atal S. Ulinastatin - a newer potential therapeutic option for multiple organ dysfunction syndrome. J Basic Clin Physiol Pharmacol. 2016 Mar;27(2):91-9. doi: 10.1515/jbcpp-2015-0003.

  PMID: 26565549 RESULT

• Xu HY, Rong XS, Wang DP, Jiang SY, Zang ZD, Xia W, Zhang F, Yan J. Effect of urinary trypsin inhibitor on inflammatory cytokines and organ function in patients with cardiopulmonary bypass. Eur Rev Med Pharmacol Sci. 2017 May;21(9):2220-2225.

  PMID: 28537661 RESULT

MeSH Terms

Interventions

urinastatin; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: phd

Model Details: 1. Voluntarily sign the informed consent; 2. Age ≥18 years old and ≤70 years old; 3. Patients receiving cardiopulmonary bypass 4. Patients undergoing heart valve replacement surgery, major vascular surgery, and other cardiac surgery

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 10, 2022
• Study Start: September 16, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)