Kidney Injury, AcutePhase 2NCT00306059
Early Goal Directed Therapy for Acute Kidney Injury
A Phase 2 study testing Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury in people with Kidney Injury, Acute, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Injury, Acute
- What is being tested?
- Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2013to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years old
- occurence of the early phase of acute kidney injury
- stay on intensive care unit
Who cannot join
- chronic haemodialysis
- not given informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury
- Conditions
- Kidney Injury, Acute
- Being tested
- Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injuryProcedure or surgery
Directed therapy during 6 hours after occurence of the early phase of acute kidney injury.
| Study group | Role | What they receive |
|---|---|---|
| patients having acute kidney injury | Experimental | Not described Receives: Procedure: Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of acute kidney injury
Measured: after 48 hours
Secondary outcomes (3)
Organ failure during first 48 hours and during stay on intensive care unit
Measured: after 48 hours
Duration of stay on intensive care unit and in hospital
Measured: t0
Mortality during stay on intensive care unit
Measured: after 28 days, 60 days and during stay in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Investigators decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Injury, AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Hoste, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306059
- Sponsor's protocol ID
- 2006/096
- Status last verified
- Dec 2022
- First submitted
- 21 Mar 2006
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Goal Directed Therapy for Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT00306059
- Acronym / sponsor ID
- 2006/096
- Conditions
- Kidney Injury, Acute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigators decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients having acute kidney injury | Experimental | Procedure: Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over 18 years old
- occurence of the early phase of acute kidney injury
- stay on intensive care unit
Key exclusion criteria (2 listed)
- chronic haemodialysis
- not given informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injuryDirected therapy during 6 hours after occurence of the early phase of acute kidney injury. | Procedure or surgery | patients having acute kidney injury |
Primary outcome
Observation of acute kidney injury
Time frame: after 48 hours
3 secondary outcomes
Organ failure during first 48 hours and during stay on intensive care unit
Time frame: after 48 hours
Duration of stay on intensive care unit and in hospital
Time frame: t0
Mortality during stay on intensive care unit
Time frame: after 28 days, 60 days and during stay in hospital
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Website University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hoste, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury in people with Kidney Injury, Acute, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observation of acute kidney injury (time frame: after 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.