Early Goal Directed Therapy for Acute Kidney Injury

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014