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

Primary Purpose

Acute Renal Failure

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
continuous renal replacement therapy
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Renal Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King Chulalongkorn Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

High NGAL and early RRT

High NGAL and late RRT

Low NGAL

Arm Description

NGAL level > 400 ng/ml and start continuous renal replacement therapy early

NGAL > 400 ng/ml and start continuous renal replacement therapy late

NGAL < 400 ng/ml and starting continuous renal replacement therapy follow with absolute indication

Outcomes

Primary Outcome Measures

mortality rate

Secondary Outcome Measures

ventilator free-days

Full Information

First Posted
March 18, 2013
Last Updated
January 26, 2016
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT01819038
Brief Title
Early Renal Replacement Therapy and the Outcome of Acute Kidney Injury
Acronym
EarlyRRT
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High NGAL and early RRT
Arm Type
Experimental
Arm Description
NGAL level > 400 ng/ml and start continuous renal replacement therapy early
Arm Title
High NGAL and late RRT
Arm Type
Experimental
Arm Description
NGAL > 400 ng/ml and start continuous renal replacement therapy late
Arm Title
Low NGAL
Arm Type
Active Comparator
Arm Description
NGAL < 400 ng/ml and starting continuous renal replacement therapy follow with absolute indication
Intervention Type
Procedure
Intervention Name(s)
continuous renal replacement therapy
Primary Outcome Measure Information:
Title
mortality rate
Time Frame
28 day
Secondary Outcome Measure Information:
Title
ventilator free-days
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
hemodialysis free-days
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nattachai Srisawat, M.D.
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

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Early Renal Replacement Therapy and the Outcome of Acute Kidney Injury

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