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:
University Hospital, Ghent
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
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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 Renal Insufficiency Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013