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

Sponsor
Chulalongkorn University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03727997
Collaborator
(none)
5,000
Enrollment
1
Location
49
Anticipated Duration (Months)
102.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Epidemiology and Long Term Outcome of Critically Ill Patients Requiring Renal Replacement Therapy in Southeast Asia and India (InSEA-RRT Registry)
    Actual Study Start Date :
    Apr 1, 2019
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    May 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    AKI patients stage 3

    Outcome Measures

    Primary Outcome Measures

    1. 2-year mortality [2-year]

    Secondary Outcome Measures

    1. Hospital mortality [28-day]

    2. RRT rate [28-day]

    3. Renal recovery [28-day]

      Number of Participants with who survive. Number of Participants with dialysis independence and creatinine <1.5 mg/dL

    4. 2-year major adverse kidney events [2-year]

      Number of Participants with 25% or greater decline in eGFR. Number of participants who receive new renal replacement therapy (RRT).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • AKI stage 3

    • At least 18 years old

    Exclusion Criteria:
    • ESRD patients (eGFR < 15 mL/min/1.73 m2)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine, Chulalongkorn University Bangkok Pathumwan Thailand 10330

    Sponsors and Collaborators

    • Chulalongkorn University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nattachai Srisawat ,M.D., Faculty of Medicine, Chulalongkorn University
    ClinicalTrials.gov Identifier:
    NCT03727997
    Other Study ID Numbers:
    • InSEA-RRT Registry
    First Posted:
    Nov 1, 2018
    Last Update Posted:
    Apr 1, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nattachai Srisawat ,M.D., Faculty of Medicine, Chulalongkorn University
    Acute kidney injury
    Renal replacement therapy
    Intensive Care Unit
    Additional relevant MeSH terms:
    Acute Kidney Injury

    Study Results

    No Results Posted as of Apr 1, 2022