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RCA for CRRT in Liver Failure and High Risk Bleeding Patients

Primary Purpose

Liver Failure

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Regional citrate anticoagulation
No-anticoagulation
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Failure focused on measuring CRRT, liver failure, filter lifespan, bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xijing Hospital of NephrologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No-anticoagulation

Regional citrate anticoagulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Filter failure
Filter failure

Secondary Outcome Measures

Serum Total Ca2+/ion Ca2+ level
Serum Total Ca2+/ ionized Ca2+ level
Hypocalcemia
Ionized Ca2+ < 1.0
Acidosis
Blood pH < 7.35
Alkalosis
Blood pH > 7.45
Bleeding
Bleeding episode during the CRRT.
Serum citrate concentration
Citrate concentration
Serum total bilirubin level
Total bilirubin
Serum AST level
AST
Serum ALT level
ALT

Full Information

First Posted
November 12, 2018
Last Updated
December 31, 2018
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT03791190
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 6, 2018 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure
Keywords
CRRT, liver failure, filter lifespan, bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No-anticoagulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Regional citrate anticoagulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Regional citrate anticoagulation
Other Intervention Name(s)
RCA
Intervention Description
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
Intervention Name(s)
No-anticoagulation
Intervention Description
Patients accepted CRRT without anticoagulant.
Primary Outcome Measure Information:
Title
Filter failure
Description
Filter failure
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Serum Total Ca2+/ion Ca2+ level
Description
Serum Total Ca2+/ ionized Ca2+ level
Time Frame
2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
Title
Hypocalcemia
Description
Ionized Ca2+ < 1.0
Time Frame
72 hours
Title
Acidosis
Description
Blood pH < 7.35
Time Frame
72 hours
Title
Alkalosis
Description
Blood pH > 7.45
Time Frame
72 hours.
Title
Bleeding
Description
Bleeding episode during the CRRT.
Time Frame
72 hours
Title
Serum citrate concentration
Description
Citrate concentration
Time Frame
2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
Title
Serum total bilirubin level
Description
Total bilirubin
Time Frame
Every 24 hours up to 72 hours.
Title
Serum AST level
Description
AST
Time Frame
Every 24 hours up to 72 hours.
Title
Serum ALT level
Description
ALT
Time Frame
Every 24 hours up to 72 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiren Sun, Doctor
Phone
+8602984775193
Email
sunshiren@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Bai, Doctor
Phone
sunshiren@medmail.com.cn
Email
mingbai1983@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiren Sun, Doctor
Organizational Affiliation
Xijing Hospital, the Fourth Military Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ming Bai, Doctor
Organizational Affiliation
Xijing Hospital, the Fourth Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital of Nephrology
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiren Sun, M.D.
Phone
+8602984775193
Email
sunshiren@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Ming Bai, M.D.
Phone
+8602984775193
Email
mingbai1983@126.com
First Name & Middle Initial & Last Name & Degree
Shiren Sun, M.D.

12. IPD Sharing Statement

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RCA for CRRT in Liver Failure and High Risk Bleeding Patients

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