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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) (InSEA-RRT)

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ClinicalTrials.gov Identifier: NCT03727997
Recruitment Status : Not yet recruiting
First Posted : November 1, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Chulalongkorn University

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
Acute Kidney Injury

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Study Type : Observational
Estimated 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)
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : May 1, 2021

Group/Cohort
AKI patients stage 3



Primary Outcome Measures :
  1. 2-year mortality [ Time Frame: 2-year ]

Secondary Outcome Measures :
  1. Hospital mortality [ Time Frame: 28-day ]
  2. RRT rate [ Time Frame: 28-day ]
  3. Renal recovery [ Time Frame: 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 [ Time Frame: 2-year ]
    Number of Participants with 25% or greater decline in eGFR. Number of participants who receive new renal replacement therapy (RRT).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • AKI stage 3
  • At least 18 years old

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727997


Contacts
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Contact: Nattachai Srisawat, MD 66818361891 drnattachai@yahoo.com
Contact: Nuttha Lumlertgul, MD 66819521456 nlumlertgul@gmail.com

Sponsors and Collaborators
Chulalongkorn University

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Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03727997     History of Changes
Other Study ID Numbers: InSEA-RRT Registry
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chulalongkorn University:
Acute kidney injury
Renal replacement therapy
Intensive Care Unit
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases