Acute Kidney InjuryNCT02423642
Immunomodulation Effect of Regional Citrate Anticoagulation in Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
A study testing Continuous renal replacement therapy with regional citrate anticoagulation and Continuous renal replacement therapy with no anticoagulation or heparin in people with Acute Kidney Injury, run by Chulalongkorn University at 1 site in Thailand.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Continuous renal replacement therapy with regional citrate anticoagulation and Continuous renal replacement therapy with no anticoagulation or heparin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemic inflammatory response syndrome; SIRS > or = 2 meets definition
- Patients with acute kidney injury in the intensive care ward.
- Requiring continuous renal replacement therapy.
Who cannot join
- Pregnancy
- Cirrhosis
- End stage renal disease
- HIV infection
- Serum creatinine in male > 2 mg/dl and female > 1.5 mg/dl
- Bleeding
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Acute Kidney Injury
- Being tested
- Continuous renal replacement therapy with regional citrate anticoagulation, Continuous renal replacement therapy with no anticoagulation or heparin
- Keywords
- Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous renal replacement therapy with regional citrate anticoagulationProcedure or surgery
Also called Continuous veno-venous hemofiltration
CRRT with anticoagulant : regional citrate anticoagulation
Filter : AQUAMAX™ (Edwards Lifesciences)
Continuous renal replacement therapy with no anticoagulation or heparinProcedure or surgery
Also called Continuous veno-venous hemofiltration
CRRT with any anticoagulant : no anticoagulation or heparin Filter : AQUAMAX™ (Edwards Lifesciences)
| Study group | Role | What they receive |
|---|---|---|
| AKI requring CRRT and use regional citrate anticoagulation | Experimental | CRRT use regional citrate anticoagulation Receives: Procedure: Continuous renal replacement therapy with regional citrate anticoagulation |
| AKI requring CRRT and not use regional citrate anticoagulation | Experimental | CRRT not use regional citrate anticoagulation Receives: Procedure: Continuous renal replacement therapy with no anticoagulation or heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functions of inflammatory cells
CD11b expression on PMN and HLA-DR expression on monocyte
Measured: 24 hours
Regulation of inflammatory reactions and and opsonization in microorganisms
C3a and C5a
Measured: 24 hours
Activity of acute phase protein during acute inflammation
PAI-1
Measured: 24 hours
Secondary outcomes (2)
survival rate
Measured: 28 days
length of ICU stay
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startJul 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nattachai Srisawat ,M.D., Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423642
- Sponsor's protocol ID
- IRB.136/56
- Status last verified
- Mar 2021
- First submitted
- 31 Mar 2015
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33314078
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulation Effect of Regional Citrate Anticoagulation in Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT02423642
- Acronym / sponsor ID
- IRB.136/56
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI requring CRRT and use regional citrate anticoagulation | Experimental | Procedure: Continuous renal replacement therapy with regional citrate anticoagulationCRRT use regional citrate anticoagulation |
| AKI requring CRRT and not use regional citrate anticoagulation | Experimental | Procedure: Continuous renal replacement therapy with no anticoagulation or heparinCRRT not use regional citrate anticoagulation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Systemic inflammatory response syndrome; SIRS > or = 2 meets definition
- Patients with acute kidney injury in the intensive care ward.
- Requiring continuous renal replacement therapy.
Key exclusion criteria (6 listed)
- Pregnancy
- Cirrhosis
- End stage renal disease
- HIV infection
- Serum creatinine in male > 2 mg/dl and female > 1.5 mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous renal replacement therapy with regional citrate anticoagulationAlso: Continuous veno-venous hemofiltrationCRRT with anticoagulant : regional citrate anticoagulation Filter : AQUAMAX™ (Edwards Lifesciences) | Procedure or surgery | AKI requring CRRT and use regional citrate anticoagulation |
| Continuous renal replacement therapy with no anticoagulation or heparinAlso: Continuous veno-venous hemofiltrationCRRT with any anticoagulant : no anticoagulation or heparin Filter : AQUAMAX™ (Edwards Lifesciences) | Procedure or surgery | AKI requring CRRT and not use regional citrate anticoagulation |
Primary outcome
Functions of inflammatory cells
Time frame: 24 hours
CD11b expression on PMN and HLA-DR expression on monocyte
Regulation of inflammatory reactions and and opsonization in microorganisms
Time frame: 24 hours
C3a and C5a
Activity of acute phase protein during acute inflammation
Time frame: 24 hours
PAI-1
2 secondary outcomes
survival rate
Time frame: 28 days
length of ICU stay
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Derived from this study: PubMed 33314078Tsujimoto 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.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous renal replacement therapy with regional citrate anticoagulation and Continuous renal replacement therapy with no anticoagulation or heparin in people with Acute Kidney Injury, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functions of inflammatory cells (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02423642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.