Immunomodulation Effect of Regional Citrate Anticoagulation in Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
1 other identifier
interventional
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 31, 2015
CompletedFirst Posted
Study publicly available on registry
April 22, 2015
CompletedMarch 5, 2021
March 1, 2021
1.3 years
March 31, 2015
March 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Functions of inflammatory cells
CD11b expression on PMN and HLA-DR expression on monocyte
24 hours
Regulation of inflammatory reactions and and opsonization in microorganisms
C3a and C5a
24 hours
Activity of acute phase protein during acute inflammation
PAI-1
24 hours
Secondary Outcomes (2)
survival rate
28 days
length of ICU stay
28 days
Study Arms (2)
AKI requring CRRT and use regional citrate anticoagulation
EXPERIMENTALCRRT use regional citrate anticoagulation
AKI requring CRRT and not use regional citrate anticoagulation
EXPERIMENTALCRRT not use regional citrate anticoagulation
Interventions
CRRT with anticoagulant : regional citrate anticoagulation Filter : AQUAMAX™ (Edwards Lifesciences)
CRRT with any anticoagulant : no anticoagulation or heparin Filter : AQUAMAX™ (Edwards Lifesciences)
Eligibility Criteria
You may qualify if:
- Systemic inflammatory response syndrome; SIRS \> or = 2 meets definition
- Patients with acute kidney injury in the intensive care ward.
- Requiring continuous renal replacement therapy.
You may not qualify if:
- Pregnancy
- Cirrhosis
- End stage renal disease
- HIV infection
- Serum creatinine in male \> 2 mg/dl and female \> 1.5 mg/dl
- Bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sasipha Tachaboon
Bangkok, Pathumwan, 10330, Thailand
Related Publications (1)
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.
PMID: 33314078DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division of Nephrology, Department of Medicine, Faculty of Medicine
Study Record Dates
First Submitted
March 31, 2015
First Posted
April 22, 2015
Study Start
July 1, 2013
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
March 5, 2021
Record last verified: 2021-03