Early Renal Replacement Therapy and the Outcome of Acute Kidney Injury (EarlyRRT)

January 26, 2016 updated by: Nattachai Srisawat ,M.D., Chulalongkorn University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent
  • patients with acute kidney injury in the intensive care ward.

Exclusion Criteria:

  • The patient refuses to sign the consent
  • The patient is pregnant, parturient, or breastfeeding
  • End stage renal disease
  • Chronic renal failure
  • previous kidney transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High NGAL and early RRT
NGAL level > 400 ng/ml and start continuous renal replacement therapy early
Procedure: continuous renal replacement therapy
Experimental: High NGAL and late RRT
NGAL > 400 ng/ml and start continuous renal replacement therapy late
Procedure: continuous renal replacement therapy
Active Comparator: Low NGAL
NGAL < 400 ng/ml and starting continuous renal replacement therapy follow with absolute indication
Procedure: continuous renal replacement therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mortality rate
Time Frame: 28 day
28 day

Secondary Outcome Measures

Outcome Measure
Time Frame
ventilator free-days
Time Frame: 28 days
28 days

Other Outcome Measures

Outcome Measure
Time Frame
hemodialysis free-days
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Nattachai Srisawat, M.D., Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 18, 2013

First Submitted That Met QC Criteria

March 22, 2013

First Posted (Estimate)

March 27, 2013

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • chula

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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