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Early Goal Directed Therapy for Acute Kidney Injury

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ClinicalTrials.gov Identifier: NCT00306059
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : March 22, 2006
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Goal Directed Therapy for Acute Kidney Injury
Study Start Date : January 2013
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Observation of acute kidney injury [ Time Frame: after 48 hours ]

Secondary Outcome Measures :
  1. Organ failure during first 48 hours and during stay on intensive care unit [ Time Frame: after 48 hours ]
  2. Duration of stay on intensive care unit and in hospital [ Time Frame: t0 ]
  3. Mortality during stay on intensive care unit [ Time Frame: after 28 days, 60 days and during stay in hospital ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306059


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

Locations
Belgium
University Hospital Ghent 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:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00306059     History of Changes
Other Study ID Numbers: 2006/096
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

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