RCA for CRRT in Liver Failure and High Risk Bleeding Patients

Liver Failure Clinical Trial

Official title:

The Efficacy and Safety of Regional Citrate Anticoagulation Versus No-anticoagulation for CRRT in Patients With Liver Failure and High Risk Bleeding: a Randomized, Control, Open-labeled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03791190
• Other study ID #: RCA for CRRT in liver failure
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2018
• Est. completion date: August 30, 2021

Study information

• Verified date: December 2018
• Source: Fourth Military Medical University
• Contact: Shiren Sun, Doctor
• Phone: +8602984775193
• Email: sunshiren[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Hepatic Insufficiency
• Liver Failure

Intervention

Other:
• Regional citrate anticoagulation
Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L.
• No-anticoagulation
Patients accepted CRRT without anticoagulant.

Locations

Country	Name	City	State
China	Xijing Hospital of Nephrology	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Filter failure	Filter failure	72 hours
Secondary	Serum Total Ca2+/ion Ca2+ level	Serum Total Ca2+/ ionized Ca2+ level	2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
Secondary	Hypocalcemia	Ionized Ca2+ < 1.0	72 hours
Secondary	Acidosis	Blood pH < 7.35	72 hours
Secondary	Alkalosis	Blood pH > 7.45	72 hours.
Secondary	Bleeding	Bleeding episode during the CRRT.	72 hours
Secondary	Serum citrate concentration	Citrate concentration	2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
Secondary	Serum total bilirubin level	Total bilirubin	Every 24 hours up to 72 hours.
Secondary	Serum AST level	AST	Every 24 hours up to 72 hours.
Secondary	Serum ALT level	ALT	Every 24 hours up to 72 hours.