RCA for CRRT in Liver Failure and High Risk Bleeding Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-06

Study Completion Date

2021-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Anticoagulation for Non-occlusive Portal Vein Thrombosis in Patients With Liver Cirrhosis

NCT02526303

Liver Cirrhosis Portal Vein Thrombosis Anticoagulation

WITHDRAWN NA

Anticoagulation for Advanced Cirrhotic Patients After TIPS

NCT03005444

Liver Cirrhosis

UNKNOWN NA

Albumin Infusion in Inpatients With Decompensated Cirrhosis

NCT05719051

Decompensated Cirrhosis Acute-On-Chronic Liver Failure

UNKNOWN

Early Postoperative CRRT After Liver Transplantation in ACLF Patients With Overt HE

NCT04317222

Acute-On-Chronic Liver Failure Hepatic Encephalopathy

UNKNOWN NA

To Evaluate the Safety and Efficacy of Preemptive Administration of Continuous Renal Replacement Therapy in Patients With Acute Liver Failure With Cerebral Edema

NCT04991259

Acute Liver Failure

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No-anticoagulation

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.

Group Type ACTIVE_COMPARATOR

No-anticoagulation

Intervention Type OTHER

Patients accepted CRRT without anticoagulant.

Regional citrate anticoagulation

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.

Group Type EXPERIMENTAL

Regional citrate anticoagulation

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

No-anticoagulation

Patients accepted CRRT without anticoagulant.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RCA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No