Heart Surgical ProceduresNCT02378168
6-month Follow up After Sevoflurane Postconditioning
An observational study of Heart Surgical Procedures, run by University of Zurich at 2 sites in Switzerland.
Trial summary
Retrospective analysis of a 6-month follow up within a randomised controlled study in cardiac surgery with pharmacological postconditioning (sedation on intensive care unit with sevoflurane) Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Surgical Procedures
- How many people
- 108 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Apr 2014to Nov 2014
- Phase
- Observational
- 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
Study population: All patients who had successfully completed the late postconditioning trial (NCT00924222) were included in this retrospective follow-up analysis.
All patients who had successfully completed the late post-conditioning trial were included in this retrospective follow-up analysis. Written and informed consent of all patients included in the first study had to be available.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital of Zurich
Zurich
University Hospital Zurich
Zurich
About this study
Official title: Late Postconditioning After Cardiac Surgery - Bridge From Surrogate Markers to Clinical Outcome
Retrospective analysis of a 6-month follow up within a randomised controlled study in cardiac surgery with pharmacological postconditioning (sedation on intensive care unit with sevoflurane)
Read the detailed description
Introduction: In a recent randomized controlled (RCT; NCT00924222) trial the investigators demonstrated in 102 patients that late post-conditioning with sevoflurane performed in the intensive care unit (ICU) reduced myocardial injury. These patients presented with lower troponin T values on the first post-operative day compared with patients undergoing propofol sedation. In order to assess possible clinical relevant long-term implications in patients enrolled in this study, the current retrospective analysis is performed focusing on cardiac and non-cardiac events during the first six months after surgery.
Methods: All patients who had successfully completed the late post-conditioning trial were included in this follow-up. Primary and secondary endpoints were the proportion of patients experiencing cardiac and non-cardiac events, respectively. Additionally, therapeutic interventions such as initiation or change of drug therapy, interventional treatment or surgery were assessed.
- Conditions
- Heart Surgical Procedures
- Being tested
- no intervention; retrospective study
- Keywords
- postconditioning, six month follow up, cardiac event, non-cardiac event
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention; retrospective studyOther
| Study group | Role | What they receive |
|---|---|---|
| cohort of RCT (StV 5-2007; NCT00924222) | Patient group with either sevoflurane or propofol sedation of the RCT (StV 5-2007; NCT00924222) Receives: Other: no intervention; retrospective study |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients with cardiac events
dysrhythmias, congestive heart failure and cardiac ischemic event
Measured: 6 months after cardiac surgery
Secondary outcomes (1)
proportion of patients experiencing non-cardiac events
acute or chronic pulmonary embolism, bleeding events, infections, cerebral events, acute and chronic kidney failure, defined as glomerular filtration rate below 60 ml/min
Measured: 6 months 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 posted4 Mar 2015 (estimated)
- Study startApr 2014
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Surgical ProceduresStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatrice Beck Schimmer, Prof, Principal investigator, University Hospital Zurich, Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378168
- Sponsor's protocol ID
- KEK ZH 2014-0040
- Status last verified
- Nov 2016
- First submitted
- 27 Feb 2015
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Postconditioning After Cardiac Surgery - Bridge From Surrogate Markers to Clinical Outcome
- ClinicalTrials.gov ID
- NCT02378168
- Acronym / sponsor ID
- KEK ZH 2014-0040
- Conditions
- Heart Surgical Procedures
- Keywords
- postconditioning, six month follow up, cardiac event, non-cardiac event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 4 Mar 2015 (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.
Retrospective analysis of a 6-month follow up within a randomised controlled study in cardiac surgery with pharmacological postconditioning (sedation on intensive care unit with sevoflurane)
Detailed description
Introduction: In a recent randomized controlled (RCT; NCT00924222) trial the investigators demonstrated in 102 patients that late post-conditioning with sevoflurane performed in the intensive care unit (ICU) reduced myocardial injury. These patients presented with lower troponin T values on the first post-operative day compared with patients undergoing propofol sedation. In order to assess possible clinical relevant long-term implications in patients enrolled in this study, the current retrospective analysis is performed focusing on cardiac and non-cardiac events during the first six months after surgery.
Methods: All patients who had successfully completed the late post-conditioning trial were included in this follow-up. Primary and secondary endpoints were the proportion of patients experiencing cardiac and non-cardiac events, respectively. Additionally, therapeutic interventions such as initiation or change of drug therapy, interventional treatment or surgery were assessed.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort of RCT (StV 5-2007; NCT00924222) | – | Other: no intervention; retrospective studyPatient group with either sevoflurane or propofol sedation of the RCT (StV 5-2007; NCT00924222) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who had successfully completed the late postconditioning trial (NCT00924222) were included in this retrospective follow-up analysis.
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 |
|---|---|---|
| no intervention; retrospective study | Other | cohort of RCT (StV 5-2007; NCT00924222) |
Primary outcome
the proportion of patients with cardiac events
Time frame: 6 months after cardiac surgery
dysrhythmias, congestive heart failure and cardiac ischemic event
1 secondary outcome
proportion of patients experiencing non-cardiac events
Time frame: 6 months 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 3 Nov 2016.
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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.
Beatrice Beck Schimmer, Prof principal investigator
University Hospital Zurich, Anesthesiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Surgical Procedures, run by University of Zurich at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
the proportion of patients with cardiac events (time frame: 6 months 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 3 Nov 2016.