RCA for CRRT in Liver Failure and High Risk Bleeding Patients

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Liver Failure

Treatments: Other: Regional citrate anticoagulation; Other: No-anticoagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03791190

RCA for CRRT in liver failure

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

No-anticoagulation

Active Comparator group

Description:

Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution at the speed of 2 L/h.

Treatment:

Other: No-anticoagulation

Regional citrate anticoagulation

Experimental group

Description:

Patients accepted regional citrate anticoagulation. Blood flow 120-220 ml/h. 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. Adjusting the infusion rate of sodium citrate and blood flow according to pre- and post-filtration ionCa2+. Adjusting the infusion rate of calcium gluconate according to the serum ionCa2+ level.

Treatment:

Other: Regional citrate anticoagulation