RCA for CRRT in Liver Failure and High Risk Bleeding Patients

Not Applicable

• Conditions: Liver Failure

• Registration Number: NCT03791190
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

The purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in patients with liver failure and high risk bleeding.

Detailed Description

Liver failure (LF) is a common co-morbidity in critical care patients who need continuous renal replacement therapy (CRRT). Patients with LF are usually associated with impaired coagulation, impaired metabolic ability of anticoagulants, and increased bleeding risk. KDIGO guideline recommended no-anticoagulation for CRRT in patients with liver failure and increased bleeding risk. However, the averaged CRRT circuit lifespan under no-coagulation was reported to be 7-8 hours in patients with liver failure. Commonly, a CRRT regimen needs more than 24 hours treatment, which means 3-4 filters replacement for one regimen in liver failure patients underwent no-anticoagulation CRRT. Several observational studies suggested that regional citrate anticoagulation (RCA) during CRRT was effective and safe in patients with liver failure. Therefore, the current opinions on the anticoagulation strategy for CRRT in patients with liver failure and high bleeding risk are controversial. Therefore, the purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in patients with liver failure and high risk bleeding.

Study Timeline

• Study Start: 2018-09-06
• Study First Submitted: 2018-11-12
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-28
• Last Update Submitted: 2018-12-31
• Study First Posted: 2019-01-02
• Last Update Posted: 2019-01-03
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Liver failure (acute liver failure and chronic liver failure)
• High bleeding risk
• Scheduled CRRT treatment
• Informed consent

Exclusion Criteria

• Use of other anticoagulants
• Uncorrectable hypoxemia (PaO2 < 60 mmHg) or systemic hypoperfusion shock
• Pregnancy or lactation
• Fistula, CRRT treatment time < 12 hours

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Filter failure	72 hours	Filter failure

Secondary Outcome Measures

Name	Time	Method
Acidosis	72 hours	Blood pH \< 7.35
Hypocalcemia	72 hours	Ionized Ca2+ \< 1.0
Alkalosis	72 hours.	Blood pH \> 7.45
Serum Total Ca2+/ion Ca2+ level	2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.	Serum Total Ca2+/ ionized Ca2+ level
Serum citrate concentration	2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.	Citrate concentration
Bleeding	72 hours	Bleeding episode during the CRRT.
Serum AST level	Every 24 hours up to 72 hours.	AST
Serum ALT level	Every 24 hours up to 72 hours.	ALT
Serum total bilirubin level	Every 24 hours up to 72 hours.	Total bilirubin

Trial Locations

Locations (1)

Xijing Hospital of Nephrology; 🇨🇳 Xi'an, Shaanxi, China