Elective Cardiac SurgeryPhase 2NCT00879931
Influence of Corticoids on Renal Function in Cardiac Surgery
A Phase 2 study testing Methylprednisolone in people with Elective Cardiac Surgery, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Hypothesis: Corticoid treatment in cardiac surgery works renal protective. Study design: Randomized, double blind trial in which one group of patients will receive methylprednisolone and the other group (control) will receive placebo NaCl 0.9%. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Elective Cardiac Surgery
- What is being tested?
- Methylprednisolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 20-80 year
- patients scheduled for elective cardiac surgery.
- preoperative creatinine levels of < 2mg/dl
- no corticoid treatment
Who cannot join
- non-elective surgery
- patiënts with renal dysfunction: creatinine > 2mg/dl
- patiënts treated with corticoids
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis: Corticoid treatment in cardiac surgery works renal protective.
Study design: Randomized, double blind trial in which one group of patients will receive methylprednisolone and the other group (control) will receive placebo NaCl 0.9%.
- Conditions
- Elective Cardiac Surgery
- Being tested
- Methylprednisolone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone
PlaceboDrug
Placebo (NaCl 0.9%)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | methylprednisolone Receives: Drug: Methylprednisolone |
| 2 | Placebo comparator | Placebo (NaCl 0.9%) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal dysfunction and renal failure postoperatively in cardiac surgery
Measured: within 48 hours after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Cardiac SurgeryStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefaan Bouchez, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879931
- Sponsor's protocol ID
- 2006/031
- Status last verified
- Dec 2022
- First submitted
- 10 Apr 2009
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Corticoids on Renal Function in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00879931
- Acronym / sponsor ID
- 2006/031
- Conditions
- Elective Cardiac Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 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
- 13 Apr 2009 (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.
Hypothesis: Corticoid treatment in cardiac surgery works renal protective.
Study design: Randomized, double blind trial in which one group of patients will receive methylprednisolone and the other group (control) will receive placebo NaCl 0.9%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Methylprednisolonemethylprednisolone |
| 2 | Placebo comparator | Drug: PlaceboPlacebo (NaCl 0.9%) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 20-80 year
- patients scheduled for elective cardiac surgery.
- preoperative creatinine levels of < 2mg/dl
- no corticoid treatment
Key exclusion criteria (3 listed)
- non-elective surgery
- patiënts with renal dysfunction: creatinine > 2mg/dl
- patiënts treated with corticoids
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 |
|---|---|---|
| MethylprednisoloneMethylprednisolone | Drug | 1 |
| PlaceboPlacebo (NaCl 0.9%) | Drug | 2 |
Primary outcome
Renal dysfunction and renal failure postoperatively in cardiac surgery
Time frame: within 48 hours after cardiac surgery
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 7 Dec 2022.
- 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.
Stefaan Bouchez, MD 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 Methylprednisolone in people with Elective Cardiac Surgery, 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 4 inclusion and 3 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 7 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. Some participants in this study may receive a placebo. 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 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?
Renal dysfunction and renal failure postoperatively in cardiac surgery (time frame: within 48 hours after cardiac surgery). 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 Dec 2022.