NCT03791190

RCA for CRRT in Liver Failure and High Risk Bleeding Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Failure

Interventions

Type	Name	Description
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.
OTHER	No-anticoagulation	Patients accepted CRRT without anticoagulant.

Timeline

• Start date: 2018-09-06
• Primary completion: 2021-08-30
• Completion: 2021-08-30
• First posted: 2019-01-02
• Last updated: 2019-01-03

Locations

1 site across 1 country: China