- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00306059
Early Goal Directed Therapy for Acute Kidney Injury
December 15, 2022 updated by: University Hospital, Ghent
Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury
Study Overview
Status
Withdrawn
Conditions
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ghent, Belgium, 9000
- University Hospital Ghent
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patients having acute kidney injury
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Directed therapy during 6 hours after occurence of the early phase of acute kidney injury.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Observation of acute kidney injury
Time Frame: after 48 hours
|
after 48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Organ failure during first 48 hours and during stay on intensive care unit
Time Frame: after 48 hours
|
after 48 hours
|
Duration of stay on intensive care unit and in hospital
Time Frame: t0
|
t0
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Mortality during stay on intensive care unit
Time Frame: after 28 days, 60 days and during stay in hospital
|
after 28 days, 60 days and during stay in hospital
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric Hoste, MD, PhD, University Hospital, Ghent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2013
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
March 21, 2006
First Submitted That Met QC Criteria
March 21, 2006
First Posted (Estimate)
March 22, 2006
Study Record Updates
Last Update Posted (Actual)
December 20, 2022
Last Update Submitted That Met QC Criteria
December 15, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006/096
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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