Liver Failure
Conditions
Keywords
CRRT, liver failure, filter lifespan, bleeding
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.
Interventions
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.
OTHERNo-anticoagulation
Patients accepted CRRT without anticoagulant.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Filter failure | 72 hours | Filter failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypocalcemia | 72 hours | Ionized Ca2+ \< 1.0 |
| Acidosis | 72 hours | Blood pH \< 7.35 |
| Alkalosis | 72 hours. | Blood pH \> 7.45 |
| Bleeding | 72 hours | Bleeding episode during the CRRT. |
| Serum Total Ca2+/ion Ca2+ level | 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours. | Serum Total Ca2+/ ionized Ca2+ level |
| Serum total bilirubin level | Every 24 hours up to 72 hours. | Total bilirubin |
| Serum AST level | Every 24 hours up to 72 hours. | AST |
| Serum ALT level | Every 24 hours up to 72 hours. | ALT |
| Serum citrate concentration | 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours. | Citrate concentration |
Countries
China
Contacts
Primary ContactShiren Sun, Doctor
Backup ContactMing Bai, Doctor
Outcome results
None listed