Acute Kidney InjuryInSEA-RRTNCT03727997
Epidemiology and Long Term Outcome of Critically Ill Patients Requiring Renal Replacement Therapy in Southeast Asia and India (InSEA-RRT Registry)
An observational study of Acute Kidney Injury, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Acute kidney injury is associated with increased short-term and long-term morbidity and mortality. Long-term data is lacking in low to middle-income countries. Our study aims to follow the acute kidney injury patients stage 3 in intensive care units for 2 years to observe mortality and associated factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 2,315 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2019to 1 Dec 2024
- Phase
- Observational
- 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
Study population: Patients who are admitted in intensive care units who are diagnosed with acute kidney injury by KDIGO criteria (cr or urine output criteria) stage 3
Who may be able to join
- AKI stage 3
- At least 18 years old
Who cannot join
- ESRD patients (eGFR < 15 mL/min/1.73 m2)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Chulalongkorn University
Bangkok, Pathumwan, 10330
About this study
Acute kidney injury is associated with increased short-term and long-term morbidity and mortality. Long-term data is lacking in low to middle-income countries. Our study aims to follow the acute kidney injury patients stage 3 in intensive care units for 2 years to observe mortality and associated factors.
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, Renal replacement therapy, Intensive Care Unit
- 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.
| Study group | Role | What they receive |
|---|---|---|
| AKI patients stage 3 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year mortality
Measured: 2-year
Secondary outcomes (4)
Hospital mortality
Measured: 28-day
RRT rate
Measured: 28-day
Renal recovery
Number of Participants with who survive. Number of Participants with dialysis independence and creatinine <1.5 mg/dL
Measured: 28-day
2-year major adverse kidney events
Number of Participants with 25% or greater decline in eGFR. Number of participants who receive new renal replacement therapy (RRT).
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start1 Apr 2019
- Primary completion1 Dec 2022
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,315 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
- NCT03727997
- Sponsor's protocol ID
- InSEA-RRT Registry
- Acronym
- InSEA-RRT
- Status last verified
- Jul 2025
- First submitted
- 26 Oct 2018
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Long Term Outcome of Critically Ill Patients Requiring Renal Replacement Therapy in Southeast Asia and India (InSEA-RRT Registry)
- ClinicalTrials.gov ID
- NCT03727997
- Acronym / sponsor ID
- InSEA-RRT / InSEA-RRT Registry
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, Renal replacement therapy, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,315 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 1 Nov 2018 (actual)
- 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.
Acute kidney injury is associated with increased short-term and long-term morbidity and mortality. Long-term data is lacking in low to middle-income countries. Our study aims to follow the acute kidney injury patients stage 3 in intensive care units for 2 years to observe mortality and associated factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AKI patients stage 3 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are admitted in intensive care units who are diagnosed with acute kidney injury by KDIGO criteria (cr or urine output criteria) stage 3
Key inclusion criteria (2 listed)
- AKI stage 3
- At least 18 years old
Key exclusion criteria (1 listed)
- ESRD patients (eGFR < 15 mL/min/1.73 m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
2-year mortality
Time frame: 2-year
4 secondary outcomes
Hospital mortality
Time frame: 28-day
RRT rate
Time frame: 28-day
Renal recovery
Time frame: 28-day
2-year major adverse kidney events
Time frame: 2-year
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 3 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
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Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
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Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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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?
An observational study of 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 2 inclusion and 1 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 3 Aug 2025. 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?
2-year mortality (time frame: 2-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2025.