NCT01819038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

December 1, 2015

Enrollment Period

2.9 years

First QC Date

March 18, 2013

Last Update Submit

January 26, 2016

Conditions

Acute Renal Failure

Outcome Measures

Primary Outcomes (1)

  • mortality rate

    28 day

Secondary Outcomes (1)

  • ventilator free-days

    28 days

Other Outcomes (1)

  • hemodialysis free-days

    28 days

Study Arms (3)

High NGAL and early RRT

EXPERIMENTAL

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

Procedure: continuous renal replacement therapy

High NGAL and late RRT

EXPERIMENTAL

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

Procedure: continuous renal replacement therapy

Low NGAL

ACTIVE COMPARATOR

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

Procedure: continuous renal replacement therapy

Interventions

continuous renal replacement therapyPROCEDURE
High NGAL and early RRTHigh NGAL and late RRTLow NGAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, 10330, Thailand

Location

Related Publications (1)

  • Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.

    PMID: 36416787DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Nattachai Srisawat, M.D.

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 27, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 28, 2016

Record last verified: 2015-12

Locations

TH(1)