Renal FunctionNCT00117390
Evaluation of the Optimal Technique for Determination of Renal Function of Critically Ill Patients
A study testing Measurement of inulin clearance in people with Renal Function and Critical Illness, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the optimal technique for determination of the renal function of critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Function, Critical Illness
- What is being tested?
- Measurement of inulin clearance
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2004to Oct 2006
- Phase
- Interventional
- 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
- Intensive care patient
- Given informed consent
- Arterial infusion
- A bladder catheter
Who cannot join
- Diurese < 400 mL/d
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Optimal Technique for Determination of the Renal Function of Critically Ill Patients
The purpose of this study is to evaluate the optimal technique for determination of the renal function of critically ill patients.
- Conditions
- Renal Function, Critical Illness
- Being tested
- Measurement of inulin clearance
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of inulin clearanceProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the determination of the renal function by other means than the golden standard, inulin clearance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2005 (estimated)
- Study startJun 2004
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FunctionStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Eric Hoste, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117390
- Sponsor's protocol ID
- 2004/101
- Status last verified
- Dec 2007
- First submitted
- 30 Jun 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Optimal Technique for Determination of the Renal Function of Critically Ill Patients
- ClinicalTrials.gov ID
- NCT00117390
- Acronym / sponsor ID
- 2004/101
- Conditions
- Renal Function, Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jun 2004
- Study completion
- Oct 2006 (actual)
- First posted
- 6 Jul 2005 (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.
The purpose of this study is to evaluate the optimal technique for determination of the renal function of critically ill patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years old
- Intensive care patient
- Given informed consent
- Arterial infusion
- A bladder catheter
Key exclusion criteria (1 listed)
- Diurese < 400 mL/d
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 |
|---|---|---|
| Measurement of inulin clearance | Procedure or surgery | – |
Primary outcome
Comparison of the determination of the renal function by other means than the golden standard, inulin clearance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
- Website of the 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 study testing Measurement of inulin clearance in people with Renal Function and Critical Illness, 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 28 Dec 2007. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of the determination of the renal function by other means than the golden standard, inulin clearance. 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 28 Dec 2007.