A clinical study of complications in patients with coronary heart disease

A study about the effect of ulinastatin in contrast-associated acute kidney injury in coronary heart disease patients with chronic kidney disease

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300074837

Enrollment

Unknown

Registered

2023-08-17

Start date

2023-09-01

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

coronary heart disease, contrast-associated acute kidney injury

Interventions

Ulinastatin Group:Standard hydration regimen was given before and after angiography according to the guidelines. At the same time, ulinastatin 20wu was given intravenously 1 day before angiography, an

Conventional treatment group:Before angiography, 1000ml of 0.9% sodium chloride injection was administered intravenously (completed within 12 hours)

After contrast examination, 1000ml of 0.9% sodium chloride injection was administered (completed within 12 hours)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age =18 years old, gender is not limited; (2) eGFR 15-60 ml/min/1.73m2 (CKD-EPI formula); (3) Patients with coronary heart disease who plan to undergo coronary angiography or PCI; (4) Voluntary signing of informed consent

Exclusion criteria

Exclusion criteria: (1) Patients undergoing kidney replacement therapy such as CRRT and hemodialysis for various reasons; (2) Patients with end-stage kidney disease and kidney transplantation; (3) shock, volume insufficiency and hypotension caused by various reasons; (4) Patients who had undergone angiography or treatment within 7 days before the study; (5) Patients who plan to undergo heart valve surgery at the same time; (6) metastatic tumors or expected survival < 1 year; (7) Patients with active autoimmune diseases; (8) Patients who have used non-steroidal anti-inflammatory drugs, cisplatin and other drugs that have been identified as possible to cause kidney tissue damage 48 hours before angiography; (9) Allergic to contrast media; (10) lactating or pregnant patients; (11) Coma or mental disorder can not decide and cooperate with the researcher.

Design outcomes

Primary

Measure	Time frame
serum creatinine;serum urea nitrogen;cystatin C;homocysteine;urinary albumin creatinine ratio;urinary n-acetylglucosidase;	—

Secondary

Measure	Time frame
major adverse cardiovascular events, MACE;	—

Countries

China

Contacts

Public ContactFu Zhenhong

Chinese PLA General Hospital

Fuzhenh@126.com+86 135 2005 9489

Outcome results

None listed

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