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Immunomodulation Effect of Regional Citrate Anticoagulation in Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Continuous renal replacement therapy with regional citrate anticoagulation
Continuous renal replacement therapy with no anticoagulation or heparin
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Systemic inflammatory response syndrome; SIRS > or = 2 meets definition
  • Patients with acute kidney injury in the intensive care ward.
  • Requiring continuous renal replacement therapy.

Exclusion Criteria:

  • Pregnancy
  • Cirrhosis
  • End stage renal disease
  • HIV infection
  • Serum creatinine in male > 2 mg/dl and female > 1.5 mg/dl
  • Bleeding

Sites / Locations

  • Sasipha Tachaboon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

AKI requring CRRT and use regional citrate anticoagulation

AKI requring CRRT and not use regional citrate anticoagulation

Arm Description

CRRT use regional citrate anticoagulation

CRRT not use regional citrate anticoagulation

Outcomes

Primary Outcome Measures

Functions of inflammatory cells
CD11b expression on PMN and HLA-DR expression on monocyte
Regulation of inflammatory reactions and and opsonization in microorganisms
C3a and C5a
Activity of acute phase protein during acute inflammation
PAI-1

Secondary Outcome Measures

survival rate
length of ICU stay

Full Information

First Posted
March 31, 2015
Last Updated
March 3, 2021
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT02423642
Brief Title
Immunomodulation Effect of Regional Citrate Anticoagulation in Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to study the effect of anticoagulation in immune response with Acute Kidney Injury (AKI) undergoing Continuous Renal Replacement Therapy (CRRT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AKI requring CRRT and use regional citrate anticoagulation
Arm Type
Experimental
Arm Description
CRRT use regional citrate anticoagulation
Arm Title
AKI requring CRRT and not use regional citrate anticoagulation
Arm Type
Experimental
Arm Description
CRRT not use regional citrate anticoagulation
Intervention Type
Procedure
Intervention Name(s)
Continuous renal replacement therapy with regional citrate anticoagulation
Other Intervention Name(s)
Continuous veno-venous hemofiltration
Intervention Description
CRRT with anticoagulant : regional citrate anticoagulation Filter : AQUAMAX™ (Edwards Lifesciences)
Intervention Type
Procedure
Intervention Name(s)
Continuous renal replacement therapy with no anticoagulation or heparin
Other Intervention Name(s)
Continuous veno-venous hemofiltration
Intervention Description
CRRT with any anticoagulant : no anticoagulation or heparin Filter : AQUAMAX™ (Edwards Lifesciences)
Primary Outcome Measure Information:
Title
Functions of inflammatory cells
Description
CD11b expression on PMN and HLA-DR expression on monocyte
Time Frame
24 hours
Title
Regulation of inflammatory reactions and and opsonization in microorganisms
Description
C3a and C5a
Time Frame
24 hours
Title
Activity of acute phase protein during acute inflammation
Description
PAI-1
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
survival rate
Time Frame
28 days
Title
length of ICU stay
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Systemic inflammatory response syndrome; SIRS > or = 2 meets definition Patients with acute kidney injury in the intensive care ward. Requiring continuous renal replacement therapy. Exclusion Criteria: Pregnancy Cirrhosis End stage renal disease HIV infection Serum creatinine in male > 2 mg/dl and female > 1.5 mg/dl Bleeding
Facility Information:
Facility Name
Sasipha Tachaboon
City
Bangkok
State/Province
Pathumwan
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
33314078
Citation
Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
Results Reference
derived

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Immunomodulation Effect of Regional Citrate Anticoagulation in Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

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