Cardiac On-pump SurgeryNCT00924222
Organ Protection With Sevoflurane Postconditioning After Cardiac Surgery With Cardiopulmonary Bypass
A study testing Sevoflurane and Propofol in people with Cardiac On-pump Surgery, run by University of Zurich at 1 site in Switzerland.
Trial summary
Organ protection, volatile anesthetics, postconditioning. Sedation of patients on ICU after cardiac surgery with cardiopulmonary bypass with either propofol or sevoflurane. Evaluation of organ function and inflammatory mediators in the blood. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac On-pump Surgery
- What is being tested?
- Sevoflurane and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2007to Dec 2009
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CABG and/or heart valve surgery with CPB
- Ejection fraction (EF) = 30%
- Canadian Cardiovascular Society (CCS) classification = 3
- Ages 18 to 90 years old
Who cannot join
- Pulmonary disease: forced expiratory volume in one second (FEV1) < 80%; FEV1/forced vital capacity (FVC) < 70%
- Renal disease and/ or creatinine-clearance < 60 ml/min
- Previous cardiac surgery
- Emergency procedures
- Postoperative intra aortic balloon pump (IABP) requirement
- Myocardial infarction < 7d
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- Steroid treatment
- Insulin-dependent diabetes
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Organ protection, volatile anesthetics, postconditioning.
Sedation of patients on ICU after cardiac surgery with cardiopulmonary bypass with either propofol or sevoflurane. Evaluation of organ function and inflammatory mediators in the blood.
- Conditions
- Cardiac On-pump Surgery
- Being tested
- Sevoflurane, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Sedation with sevoflurane
PropofolDrug
Sedation on intensive care unit with propofol
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | Not described Receives: Drug: Sevoflurane; Drug: Propofol |
| Propofol | Experimental | Not described Receives: Drug: Sevoflurane; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial injury markers (myoglobin, creatine kinase, myocard specific creatine kinase, and troponin T)
Measured: Start and end of ICU stay
Secondary outcomes (1)
Oxygenation index, postoperative pulmonary complications, ICU stay (days), length of hospitalisation
Measured: Start with surgery until end of hospitalisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startOct 2007
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac On-pump SurgeryStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924222
- Sponsor's protocol ID
- IFA-5-2007
- Status last verified
- Oct 2011
- First submitted
- 17 Jun 2009
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Steurer MP, Steurer MA, Baulig W, Piegeler T, Schlapfer M, Spahn DR, Falk V, Dreessen P, Theusinger OM, Schmid ER, Schwartz D, Neff TA, Beck-Schimmer B. Late pharmacologic conditioning with volatile anesthetics after cardiac surgery. Crit Care. 2012 Oct 14;16(5):R191. doi: 10.1186/cc11676.
PubMed 23062276
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organ Protection With Sevoflurane Postconditioning After Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00924222
- Acronym / sponsor ID
- IFA-5-2007
- Conditions
- Cardiac On-pump Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Jun 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.
Organ protection, volatile anesthetics, postconditioning.
Sedation of patients on ICU after cardiac surgery with cardiopulmonary bypass with either propofol or sevoflurane. Evaluation of organ function and inflammatory mediators in the blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: Sevoflurane, Drug: Propofol |
| Propofol | Experimental | Drug: Sevoflurane, Drug: Propofol |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CABG and/or heart valve surgery with CPB
- Ejection fraction (EF) = 30%
- Canadian Cardiovascular Society (CCS) classification = 3
- Ages 18 to 90 years old
Key exclusion criteria (9 listed)
- Pulmonary disease: forced expiratory volume in one second (FEV1) < 80%; FEV1/forced vital capacity (FVC) < 70%
- Renal disease and/ or creatinine-clearance < 60 ml/min
- Previous cardiac surgery
- Emergency procedures
- Postoperative intra aortic balloon pump (IABP) requirement
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 |
|---|---|---|
| SevofluraneSedation with sevoflurane | Drug | Propofol, Sevoflurane |
| PropofolSedation on intensive care unit with propofol | Drug | Propofol, Sevoflurane |
Primary outcome
Myocardial injury markers (myoglobin, creatine kinase, myocard specific creatine kinase, and troponin T)
Time frame: Start and end of ICU stay
1 secondary outcome
Oxygenation index, postoperative pulmonary complications, ICU stay (days), length of hospitalisation
Time frame: Start with surgery until end of hospitalisation
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 12 Oct 2011.
- Derived from this study: PubMed 23062276Steurer MP, Steurer MA, Baulig W, Piegeler T, Schlapfer M, Spahn DR, Falk V, Dreessen P, Theusinger OM, Schmid ER, Schwartz D, Neff TA, Beck-Schimmer B. Late pharmacologic conditioning with volatile anesthetics after cardiac surgery. Crit Care. 2012 Oct 14;16(5):R191. doi: 10.1186/cc11676.
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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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane and Propofol in people with Cardiac On-pump Surgery, run by University of Zurich at 1 site in Switzerland.
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 9 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 12 Oct 2011. 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 Switzerland. 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?
Myocardial injury markers (myoglobin, creatine kinase, myocard specific creatine kinase, and troponin T) (time frame: Start and end of ICU stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00924222, which also lists 1 linked publication.
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 12 Oct 2011.