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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03791190
Other study ID # RCA for CRRT in liver failure
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 6, 2018
Est. completion date August 30, 2021

Study information

Verified date December 2018
Source Fourth Military Medical University
Contact Shiren Sun, Doctor
Phone +8602984775193
Email sunshiren@medmail.com.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date August 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
No-anticoagulation
Patients accepted CRRT without anticoagulant.

Locations

Country Name City State
China Xijing Hospital of Nephrology Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Filter failure Filter failure 72 hours
Secondary Serum Total Ca2+/ion Ca2+ level Serum Total Ca2+/ ionized Ca2+ level 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
Secondary Hypocalcemia Ionized Ca2+ < 1.0 72 hours
Secondary Acidosis Blood pH < 7.35 72 hours
Secondary Alkalosis Blood pH > 7.45 72 hours.
Secondary Bleeding Bleeding episode during the CRRT. 72 hours
Secondary Serum citrate concentration Citrate concentration 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
Secondary Serum total bilirubin level Total bilirubin Every 24 hours up to 72 hours.
Secondary Serum AST level AST Every 24 hours up to 72 hours.
Secondary Serum ALT level ALT Every 24 hours up to 72 hours.
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