NCT03791190

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 2, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

January 3, 2019

Status Verified

December 1, 2018

Enrollment Period

3 years

First QC Date

November 12, 2018

Last Update Submit

December 31, 2018

Conditions

Liver Failure

Keywords

CRRTliver failurefilter lifespanbleeding

Outcome Measures

Primary Outcomes (1)

  • Filter failure

    Filter failure

    72 hours

Secondary Outcomes (9)

  • Serum Total Ca2+/ion Ca2+ level

    2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.

  • Hypocalcemia

    72 hours

  • Acidosis

    72 hours

  • Alkalosis

    72 hours.

  • Bleeding

    72 hours

  • +4 more secondary outcomes

Study Arms (2)

No-anticoagulation

ACTIVE COMPARATOR

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.

Other: No-anticoagulation

Regional citrate anticoagulation

EXPERIMENTAL

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.

Other: Regional citrate anticoagulation

Interventions

Regional citrate anticoagulationOTHER

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.

Also known as: RCA
Regional citrate anticoagulation
No-anticoagulationOTHER

Patients accepted CRRT without anticoagulant.

No-anticoagulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Liver failure (acute liver failure and chronic liver failure)
  • High bleeding risk
  • Scheduled CRRT treatment
  • Informed consent

You may not qualify if:

  • Use of other anticoagulants
  • Uncorrectable hypoxemia (PaO2 \< 60 mmHg) or systemic hypoperfusion shock
  • Pregnancy or lactation
  • Fistula, CRRT treatment time \< 12 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital of Nephrology

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (1)

  • Bai M, Yu Y, Zhao L, Tian X, Zhou M, Jiao J, Liu Y, Li Y, Yue Y, Wei L, Jing R, Li Y, Ma F, Liang Y, Sun S. Regional Citrate Anticoagulation versus No Anticoagulation for CKRT in Patients with Liver Failure with Increased Bleeding Risk. Clin J Am Soc Nephrol. 2024 Feb 1;19(2):151-160. doi: 10.2215/CJN.0000000000000351. Epub 2023 Nov 6.

    PMID: 37990929DERIVED

MeSH Terms

Conditions

Liver FailureHemorrhage

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shiren Sun, Doctor

    Xijing Hospital, the Fourth Military Medical University

    STUDY CHAIR

  • Ming Bai, Doctor

    Xijing Hospital, the Fourth Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiren Sun, Doctor

CONTACT

+8602984775193sunshiren@medmail.com.cn

Ming Bai, Doctor

CONTACT

sunshiren@medmail.com.cnmingbai1983@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 12, 2018

First Posted

January 2, 2019

Study Start

September 6, 2018

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

January 3, 2019

Record last verified: 2018-12

Locations

CN(1)