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

NCT ID: NCT02423642

Last Updated: 2021-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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AKI requring CRRT and use regional citrate anticoagulation

CRRT use regional citrate anticoagulation

Group Type EXPERIMENTAL

Continuous renal replacement therapy with regional citrate anticoagulation

Intervention Type PROCEDURE

CRRT with anticoagulant : regional citrate anticoagulation

Filter : AQUAMAX™ (Edwards Lifesciences)

AKI requring CRRT and not use regional citrate anticoagulation

CRRT not use regional citrate anticoagulation

Group Type EXPERIMENTAL

Continuous renal replacement therapy with no anticoagulation or heparin

Intervention Type PROCEDURE

CRRT with any anticoagulant : no anticoagulation or heparin Filter : AQUAMAX™ (Edwards Lifesciences)

Interventions

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Continuous renal replacement therapy with regional citrate anticoagulation

CRRT with anticoagulant : regional citrate anticoagulation

Filter : AQUAMAX™ (Edwards Lifesciences)

Intervention Type PROCEDURE

Continuous renal replacement therapy with no anticoagulation or heparin

CRRT with any anticoagulant : no anticoagulation or heparin Filter : AQUAMAX™ (Edwards Lifesciences)

Intervention Type PROCEDURE

Other Intervention Names

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Continuous veno-venous hemofiltration Continuous veno-venous hemofiltration

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Nattachai Srisawat ,M.D.

Division of Nephrology, Department of Medicine, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sasipha Tachaboon

Bangkok, Pathumwan, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type DERIVED
PMID: 33314078 (View on PubMed)

Other Identifiers

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IRB.136/56

Identifier Type: -

Identifier Source: org_study_id

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