Early Goal Directed Therapy for Acute Kidney Injury

This study is not yet open for participant recruitment.
Verified January 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00306059
First received: March 21, 2006
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury


Condition Intervention Phase
Kidney Injury, Acute
Procedure: Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Goal Directed Therapy for Acute Kidney Injury

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Observation of acute kidney injury [ Time Frame: after 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Organ failure during first 48 hours and during stay on intensive care unit [ Time Frame: after 48 hours ] [ Designated as safety issue: No ]
  • Duration of stay on intensive care unit and in hospital [ Time Frame: t0 ] [ Designated as safety issue: No ]
  • Mortality during stay on intensive care unit [ Time Frame: after 28 days, 60 days and during stay in hospital ] [ Designated as safety issue: No ]

Estimated Enrollment: 340
Study Start Date: January 2013
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patients having acute kidney injury Procedure: Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury
Directed therapy during 6 hours after occurence of the early phase of acute kidney injury.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • over 18 years old
  • occurence of the early phase of acute kidney injury
  • stay on intensive care unit

Exclusion Criteria:

  • chronic haemodialysis
  • not given informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306059

Contacts
Contact: Eric Hoste, MD, PhD +32 9 332.41.97 eric.hoste@UGent.be

Locations
Belgium
University Hospital Ghent Not yet recruiting
Ghent, Belgium, 9000
Contact: Eric Hoste, MD, PhD    + 32 9 332.41.97    eric.hoste@UGent.be   
Principal Investigator: Eric Hoste, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Eric Hoste, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00306059     History of Changes
Other Study ID Numbers: 2006/096
Study First Received: March 21, 2006
Last Updated: January 29, 2013
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014