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

Sponsor
Chulalongkorn University (Other)
Overall Status
Completed
CT.gov ID
NCT02423642
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
16
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Continuous renal replacement therapy with regional citrate anticoagulation
  • Procedure: Continuous renal replacement therapy with no anticoagulation or heparin
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: AKI requring CRRT and use regional citrate anticoagulation

CRRT use regional citrate anticoagulation

Procedure: Continuous renal replacement therapy with regional citrate anticoagulation
CRRT with anticoagulant : regional citrate anticoagulation Filter : AQUAMAX™ (Edwards Lifesciences)
Other Names:
  • Continuous veno-venous hemofiltration

    		•
    Experimental: AKI requring CRRT and not use regional citrate anticoagulation

    CRRT not use regional citrate anticoagulation

    Procedure: Continuous renal replacement therapy with no anticoagulation or heparin
    CRRT with any anticoagulant : no anticoagulation or heparin Filter : AQUAMAX™ (Edwards Lifesciences)
    Other Names:
  • Continuous veno-venous hemofiltration

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Functions of inflammatory cells [24 hours]

      CD11b expression on PMN and HLA-DR expression on monocyte

    2. Regulation of inflammatory reactions and and opsonization in microorganisms [24 hours]

      C3a and C5a

    3. Activity of acute phase protein during acute inflammation [24 hours]

      PAI-1

    Secondary Outcome Measures

    1. survival rate [28 days]

    2. length of ICU stay [28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sasipha Tachaboon Bangkok Pathumwan Thailand 10330

    Sponsors and Collaborators

    • Chulalongkorn University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nattachai Srisawat ,M.D., Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University
    ClinicalTrials.gov Identifier:
    NCT02423642
    Other Study ID Numbers:
    • IRB.136/56
    First Posted:
    Apr 22, 2015
    Last Update Posted:
    Mar 5, 2021
    Last Verified:
    Mar 1, 2021
    Keywords provided by Nattachai Srisawat ,M.D., Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University
    Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Heparin

    Study Results

    No Results Posted as of Mar 5, 2021