Epidemiology and Long Term Outcome of Critically Ill Pati... | NCT03727997

Studies
Epidemiology and Long Term Outcome of Critically Ill Patients Requiring Renal Replacement Therapy in Southeast Asia and India (InSEA-RRT Registry)

NCT03727997

Sponsor

Chulalongkorn University

Status

Completed

Last Update Posted

Aug 3, 2025Actual

Enrollment

2,315Actual

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

Not provided

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Dec 1, 2022Actual

Completion Date

Dec 1, 2024Actual

First Submitted Date

Oct 26, 2018

First Submission Date that Met QC Criteria

Oct 31, 2018

First Posted Date

Nov 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2025

Last Update Posted Date

Aug 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,315Actual

Label	Type	Description	Intervention Names
AKI patients stage 3

Measure	Description	Time Frame
2-year mortality		2-year

Measure	Description	Time Frame
Hospital mortality		28-day
RRT rate		28-day
Renal recovery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AKI stage 3
At least 18 years old

Exclusion Criteria:

ESRD patients (eGFR < 15 mL/min/1.73 m2)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Chulalongkorn University		Bangkok	Pathumwan	10330	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided