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

March 3, 2021 updated by: Nattachai Srisawat ,M.D., Chulalongkorn University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathumwan
      • Bangkok, Pathumwan, Thailand, 10330
        • Sasipha tachaboon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functions of inflammatory cells
Time Frame: 24 hours
CD11b expression on PMN and HLA-DR expression on monocyte
24 hours
Regulation of inflammatory reactions and and opsonization in microorganisms
Time Frame: 24 hours
C3a and C5a
24 hours
Activity of acute phase protein during acute inflammation
Time Frame: 24 hours
PAI-1
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
survival rate
Time Frame: 28 days
28 days
length of ICU stay
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

March 31, 2015

First Submitted That Met QC Criteria

April 19, 2015

First Posted (ESTIMATE)

April 22, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB.136/56

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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