Peritoneal DialysisPhase 2NCT00426114
Acute Haemodynamic Impact of an IV Glucose-injection
A Phase 2 study testing Administration of an IV glucose-injection in people with Peritoneal Dialysis, run by University Hospital, Ghent.
Trial summary
Patients with peritoneal dialysis will be administered an IV glucose-injection to evaluate the haemodynamic impact of this injection. The patients will be matched with healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peritoneal Dialysis
- What is being tested?
- Administration of an IV glucose-injection
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 years old
- Stable clinical condition
- Either peritoneal dialysis (at least one month) either matched healthy subject
Who cannot join
- Heart Failure
- Diabetes requiring insulin treatment
About this study
Patients with peritoneal dialysis will be administered an IV glucose-injection to evaluate the haemodynamic impact of this injection. The patients will be matched with healthy volunteers.
- Conditions
- Peritoneal Dialysis
- Being tested
- Administration of an IV glucose-injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of an IV glucose-injectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemodynamic parameters
Glycemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2007 (estimated)
Why it stopped: never started due to logistic issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- 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
- Wim Van Biesen, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426114
- Sponsor's protocol ID
- 2007/016
- Status last verified
- Jul 2021
- First submitted
- 23 Jan 2007
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Haemodynamic Impact of an IV Glucose-injection
- ClinicalTrials.gov ID
- NCT00426114
- Acronym / sponsor ID
- 2007/016
- Conditions
- Peritoneal Dialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: never started due to logistic issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- First posted
- 24 Jan 2007 (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.
Patients with peritoneal dialysis will be administered an IV glucose-injection to evaluate the haemodynamic impact of this injection. The patients will be matched with healthy volunteers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years old
- Stable clinical condition
- Either peritoneal dialysis (at least one month) either matched healthy subject
Key exclusion criteria (2 listed)
- Heart Failure
- Diabetes requiring insulin treatment
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 |
|---|---|---|
| Administration of an IV glucose-injection | Drug | – |
Primary outcome
Haemodynamic parameters
Glycemia
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 7 Jul 2021.
- Website of the University Hospital GhentLink provided by the sponsor.
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Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
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Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
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Iodine Starch Test Use in Pleuroperitoneal Leak
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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.
Wim Van Biesen, MD, PhD principal investigator
University Hospital, Ghent
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Administration of an IV glucose-injection in people with Peritoneal Dialysis, run by University Hospital, Ghent.
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 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Haemodynamic parameters. The study lists 2 primary outcomes in all. 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 7 Jul 2021.