Back to resultsEarly Goal Directed Therapy for Acute Kidney Injury
Primary Purpose
Kidney Injury, Acute
Status
Withdrawn
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Injury, Acute
Eligibility 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
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients having acute kidney injury
Arm Description
Outcomes
Primary Outcome Measures
Observation of acute kidney injury
Secondary Outcome Measures
Organ failure during first 48 hours and during stay on intensive care unit
Duration of stay on intensive care unit and in hospital
Mortality during stay on intensive care unit
Full Information
NCT ID
NCT00306059
First Posted
March 21, 2006
Last Updated
December 15, 2022
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00306059
Brief Title
Early Goal Directed Therapy for Acute Kidney Injury
Official Title
Early Goal Directed Therapy for Acute Kidney Injury
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Investigators decision
Study Start Date
January 2013 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Injury, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients having acute kidney injury
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury
Intervention Description
Directed therapy during 6 hours after occurence of the early phase of acute kidney injury.
Primary Outcome Measure Information:
Title
Observation of acute kidney injury
Time Frame
after 48 hours
Secondary Outcome Measure Information:
Title
Organ failure during first 48 hours and during stay on intensive care unit
Time Frame
after 48 hours
Title
Duration of stay on intensive care unit and in hospital
Time Frame
t0
Title
Mortality during stay on intensive care unit
Time Frame
after 28 days, 60 days and during stay in hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Hoste, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent
Learn more about this trial
Early Goal Directed Therapy for Acute Kidney Injury
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