Clinical trial NCT03791190: RCA for CRRT in Liver Failure and High Risk Bleeding Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Failure
Keywords: CRRT
liver failure
filter lifespan
bleeding
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2019-01-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Filter failure
timeFrame: 72 hours
Secondary outcomes:
measure: Serum Total Ca2+/ion Ca2+ level
timeFrame: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
measure: Hypocalcemia
timeFrame: 72 hours
measure: Acidosis
timeFrame: 72 hours
measure: Alkalosis
timeFrame: 72 hours.
measure: Bleeding
timeFrame: 72 hours
measure: Serum citrate concentration
timeFrame: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
measure: Serum total bilirubin level
timeFrame: Every 24 hours up to 72 hours.
measure: Serum AST level
timeFrame: Every 24 hours up to 72 hours.
measure: Serum ALT level
timeFrame: Every 24 hours up to 72 hours.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Nephrology
state: Shaanxi
Study officials:
affiliation: Xijing Hospital, the Fourth Military Medical University
name: Shiren Sun, Doctor
role: STUDY_CHAIR
affiliation: Xijing Hospital, the Fourth Military Medical University
name: Ming Bai, Doctor
role: PRINCIPAL_INVESTIGATOR
References: