Acute Renal FailureEarlyRRTNCT01819038
Early Renal Replacement Therapy and the Outcome of Acute Kidney Injury
A study testing continuous renal replacement therapy in people with Acute Renal Failure, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This research project is a prospective study to compare mortality between early renal replacement therapy (RRT) and late renal replacement therapy by using plasma neutrophil gelatinase associated lipocalin (pNGAL) as a tool in decision- making. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure
- What is being tested?
- continuous renal replacement therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2013to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given his/her informed and signed consent
- patients with acute kidney injury in the intensive care ward.
Who cannot join
- The patient refuses to sign the consent
- The patient is pregnant, parturient, or breastfeeding
- End stage renal disease
- Chronic renal failure
- previous kidney transplant
Trial locations and contacts
1 site in 1 country.
About this study
This research project is a prospective study to compare mortality between early renal replacement therapy (RRT) and late renal replacement therapy by using plasma neutrophil gelatinase associated lipocalin (pNGAL) as a tool in decision- making.
- Conditions
- Acute Renal Failure
- Being tested
- 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 therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| High NGAL and early RRT | Experimental | NGAL level > 400 ng/ml and start continuous renal replacement therapy early Receives: Procedure: continuous renal replacement therapy |
| High NGAL and late RRT | Experimental | NGAL > 400 ng/ml and start continuous renal replacement therapy late Receives: Procedure: continuous renal replacement therapy |
| Low NGAL | Active comparator | NGAL < 400 ng/ml and starting continuous renal replacement therapy follow with absolute indication Receives: Procedure: continuous renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
Measured: 28 day
Secondary outcomes (1)
ventilator free-days
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 posted27 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionDec 2015
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 Renal FailureStudies 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, Investigator
- Enrolment
- 60 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
- Investigators
- Nattachai Srisawat, M.D., Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819038
- Sponsor's protocol ID
- chula
- Acronym
- EarlyRRT
- Status last verified
- Dec 2015
- First submitted
- 18 Mar 2013
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.
PubMed 36416787
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Renal Replacement Therapy and the Outcome of Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT01819038
- Acronym / sponsor ID
- EarlyRRT / chula
- Conditions
- Acute Renal Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Mar 2013 (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.
This research project is a prospective study to compare mortality between early renal replacement therapy (RRT) and late renal replacement therapy by using plasma neutrophil gelatinase associated lipocalin (pNGAL) as a tool in decision- making.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High NGAL and early RRT | Experimental | Procedure: continuous renal replacement therapyNGAL level > 400 ng/ml and start continuous renal replacement therapy early |
| High NGAL and late RRT | Experimental | Procedure: continuous renal replacement therapyNGAL > 400 ng/ml and start continuous renal replacement therapy late |
| Low NGAL | Active comparator | Procedure: continuous renal replacement therapyNGAL < 400 ng/ml and starting continuous renal replacement therapy follow with absolute indication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient must have given his/her informed and signed consent
- patients with acute kidney injury in the intensive care ward.
Key exclusion criteria (5 listed)
- The patient refuses to sign the consent
- The patient is pregnant, parturient, or breastfeeding
- End stage renal disease
- Chronic renal failure
- previous kidney transplant
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 | Procedure or surgery | High NGAL and early RRT, High NGAL and late RRT, Low NGAL |
Primary outcome
mortality rate
Time frame: 28 day
1 secondary outcome
ventilator free-days
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 28 Jan 2016.
- Derived from this study: PubMed 36416787Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.
Related trials for Acute Renal Failure
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 recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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)
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.
Nattachai Srisawat, M.D. principal investigator
Chulalongkorn University
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 in people with Acute Renal Failure, 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 2 inclusion and 5 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 28 Jan 2016. 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?
mortality rate (time frame: 28 day). 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 NCT01819038, 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 28 Jan 2016.