Effect of ulinastatin on prevention of acute kidney injury after cardiac surgery: a randomised, double-blinded, placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900026747

Enrollment

Unknown

Registered

2019-10-20

Start date

2019-11-30

Completion date

Unknown

Last updated

2019-10-21

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

Conditions

acute kidney injury

Interventions

Experimental group:Intravenous injection of ulinastatin

Control group:Placebo (0.9% normal saline)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Aged >=18 years; 2) Undergoing on-pump cardiac surgery, including: coronary artery bypass grafting (CABG), valve surgery (valve replacement or repair), CABG combined valve surgery, aortic root surgery; 3) Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Operation under deep hypothermic circulatory arrest (DHCA); 2) Chronic kidney disease (CKD) stage 5/5D: eGFR<15ml/min/1.73m2, or on hemodialysis/peritoneal dialysis; 3) Kidney transplant patients; 4) Pregnancy; 5) AKI detected within 4 weeks before surgery; 6) Receipt of intravenous contrast agent within 72 hours before surgery; 7) Receipt of gabexate or globulin within 1 week before surgery; 8) Allergy to ulinastatin or known intolerance.

Design outcomes

Primary

Measure	Time frame
Serum creatinine;Urine output;	—

Secondary

Measure	Time frame
CRRT;LOS-ICU;Hospitalization costs;30-day mortality;serum cystin C;Urine NGAL;	—

Countries

China

Contacts

Public ContactBo Xie

Renji Hospital, Shanghai Jiaotong University School of Medicine

xieborj@hotmail.com+86 13916228344

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026