Myocardial Reperfusion InjuryPhase 4NCT01601795
Sevoflurane and Isoflurane - During Cardiopulmonary Bypass With the MECC System (Minimized Extracorporeal Circuit)
A Phase 4 study testing Sevoflurane and Isoflurane in people with Myocardial Reperfusion Injury, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The use of volatile anesthetics in cardiac anesthesia is very common, because of their cardioprotective effects and their ability to ensure a sufficient depth of anesthesia. In line with the development of fast track concepts in cardiac anesthesia, volatile anesthetics are widely used to avoid a delayed recovery from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Reperfusion Injury
- What is being tested?
- Sevoflurane and Isoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2012to Jan 2014
- Phase
- Phase 4
- 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
- elective coronary bypass surgery
- preserved left ventricular function (LVEF (left ventricular ejection fraction) >55%)
- Age > 18 years
- planned MECC-System (minimized extracorporeal circulation)
- informed consent
Who cannot join
- chronic renal insufficiency (serum creatinine > 132umol/l)
- Body Mass Index > 35kg/m2
- additional operative procedures (eg. valve replacement/reconstruction)
- recent cardiac infarction (< 7 days) or elevated cardiac enzymes the day before surgery
- previous cardiac operation
- Pregnancy / Lactation
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- known malignant hyperthermia (MH) or known relatives with MH
- known allergy against propofol, history of propofol infusion syndrome
- Drug abuse (cocaine, amphetamine, heroine, cannabis)
- non-judicious persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sevoflurane and Isoflurane - Cardioprotective Effects, Hemodynamic Stability and Pharmacokinetics During Cardiopulmonary Bypass With the MECC System
The use of volatile anesthetics in cardiac anesthesia is very common, because of their cardioprotective effects and their ability to ensure a sufficient depth of anesthesia. In line with the development of fast track concepts in cardiac anesthesia, volatile anesthetics are widely used to avoid a delayed recovery from cardiac surgery and anesthesia. Volatile anesthetics are delivered from calibrated vaporizers in the anesthesia machine or the cardiopulmonary bypass machine (during extracorporeal circulation).
Isoflurane and Sevoflurane are the most commonly used volatile anesthetics in patients undergoing cardiopulmonary bypass (CPB). The vaporizer of the anesthetics is on the cardiopulmonary bypass machine and the volatile agent is blended with air and oxygen. Until now, the pharmacokinetics of halothane, enflurane, isoflurane and desflurane during CPB have been described.
Read more
Sevoflurane might be of advantage because of additional myocardial protective effects during cardiac anesthesia and cardiopulmonary bypass. However, the pharmacokinetics of sevoflurane during CPB have not been investigated so far, although its being used at many hospitals.
The investigators will conduct a randomized prospective study with either sevoflurane or isoflurane during cardiopulmonary bypass surgery. The study will help to answer the questions about the possible cardioprotective effects of the widely used volatile anesthetics and the hemodynamic stability during cardiopulmonary bypass. Knowing the pharmacokinetics of these drugs allows the anesthesiologist to titrate the volatile anesthetics more precise.
The investigators hypothesizes that the maximal postoperative increase in troponin T will be smaller in the sevoflurane group than in the isoflurane group. The investigators hypothesizes that the total amount of noradrenaline needed during the entire period of cardiopulmonary bypass will be smaller in the sevoflurane group than in the isoflurane group. The investigators hypothesizes that kinetics of washin and washout at the CPB will be faster in the sevoflurane group than in the isoflurane group. The investigators hypothesizes that the time to extubation, respectively the length of stay in intensive care unit and hospital is shorter in the sevoflurane group than in the isoflurane group.
Read the detailed description
Endpoints Primary Endpoint: Troponin
The study will compare the maximum postoperative troponin levels in the isoflurane and sevoflurane groups as a direct quantitative marker of damaged myocardial cells. Maximum troponin levels should be reached within the first 24 hours after surgery.
Secondary Endpoints:
- Hemodynamic stability during on-pump
The investigators will compare the hemodynamic stability during CPB between the isoflurane and sevoflurane group. Therefore the total dosage of noradrenaline used during the surgery will be measured.
- Washin and Washout Kinetic
Kinetics of washin and washout of sevoflurane and isoflurane during CPB will be investigated and described.
- Extubation time and length of stay in the intensive care and in hospital
Time to extubation and the length of stay in intensive care unit and in hospital will be documented.
- Mortality after 30 days
The mortality after 30 days will also be monitored. If the patient is no more in the hospital a phone call will be made.
- Conditions
- Myocardial Reperfusion Injury
- Being tested
- Sevoflurane, Isoflurane
- Keywords
- Cardioprotection
- Medical subject headings
- Myocardial Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevorane
volatile Anaesthetic, duration during cardiopulmonary bypass
IsofluraneDrug
Also called Isofluran
volatile anesthetic, duration during cardiopulmonary bypass time
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Active comparator | During cardiopulmonary bypass, sevoflurane will be administered through a vaporizer integrated into heart-lung-machine. Receives: Drug: Sevoflurane |
| Isoflurane | Active comparator | During cardiopulmonary bypass, isoflurane will be administered through a vaporizer integrated into heart-lung-machine. Receives: Drug: Isoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative maximum Troponin levels
Measured: 24 hours
Secondary outcomes (1)
Hemodynamic stability during on-pump
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Reperfusion InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leipzig, RWTH Aachen University, Penn State University
- Responsible party
- Sponsor
- Investigators
- Jens Fassl, MD, Principal investigator, University Hospital Basel Departement of Anesthesiology and Intensive care medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601795
- Sponsor's protocol ID
- BS-57/12
- Other IDs
- Fassl_57/12
- Status last verified
- Jan 2014
- First submitted
- 2 May 2012
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane and Isoflurane - Cardioprotective Effects, Hemodynamic Stability and Pharmacokinetics During Cardiopulmonary Bypass With the MECC System
- ClinicalTrials.gov ID
- NCT01601795
- Acronym / sponsor ID
- BS-57/12
- Conditions
- Myocardial Reperfusion Injury
- Keywords
- Cardioprotection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Leipzig, RWTH Aachen University, Penn State University
- Study start
- Jul 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 18 May 2012 (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 use of volatile anesthetics in cardiac anesthesia is very common, because of their cardioprotective effects and their ability to ensure a sufficient depth of anesthesia. In line with the development of fast track concepts in cardiac anesthesia, volatile anesthetics are widely used to avoid a delayed recovery from cardiac surgery and anesthesia. Volatile anesthetics are delivered from calibrated vaporizers in the anesthesia machine or the cardiopulmonary bypass machine (during extracorporeal circulation).
Isoflurane and Sevoflurane are the most commonly used volatile anesthetics in patients undergoing cardiopulmonary bypass (CPB). The vaporizer of the anesthetics is on the cardiopulmonary bypass machine and the volatile agent is blended with air and oxygen. Until now, the pharmacokinetics of halothane, enflurane, isoflurane and desflurane during CPB have been described.
Sevoflurane might be of advantage because of additional myocardial protective effects during cardiac anesthesia and cardiopulmonary bypass. However, the pharmacokinetics of sevoflurane during CPB have not been investigated so far, although its being used at many hospitals.
The investigators will conduct a randomized prospective study with either sevoflurane or isoflurane during cardiopulmonary bypass surgery. The study will help to answer the questions about the possible cardioprotective effects of the widely used volatile anesthetics and the hemodynamic stability during cardiopulmonary bypass. Knowing the pharmacokinetics of these drugs allows the anesthesiologist to titrate the volatile anesthetics more precise.
The investigators hypothesizes that the maximal postoperative increase in troponin T will be smaller in the sevoflurane group than in the isoflurane group. The investigators hypothesizes that the total amount of noradrenaline needed during the entire period of cardiopulmonary bypass will be smaller in the sevoflurane group than in the isoflurane group. The investigators hypothesizes that kinetics of washin and washout at the CPB will be faster in the sevoflurane group than in the isoflurane group. The investigators hypothesizes that the time to extubation, respectively the length of stay in intensive care unit and hospital is shorter in the sevoflurane group than in the isoflurane group.
Detailed description
Endpoints Primary Endpoint: Troponin
The study will compare the maximum postoperative troponin levels in the isoflurane and sevoflurane groups as a direct quantitative marker of damaged myocardial cells. Maximum troponin levels should be reached within the first 24 hours after surgery.
Secondary Endpoints:
- Hemodynamic stability during on-pump
The investigators will compare the hemodynamic stability during CPB between the isoflurane and sevoflurane group. Therefore the total dosage of noradrenaline used during the surgery will be measured.
- Washin and Washout Kinetic
Kinetics of washin and washout of sevoflurane and isoflurane during CPB will be investigated and described.
- Extubation time and length of stay in the intensive care and in hospital
Time to extubation and the length of stay in intensive care unit and in hospital will be documented.
- Mortality after 30 days
The mortality after 30 days will also be monitored. If the patient is no more in the hospital a phone call will be made.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Active comparator | Drug: SevofluraneDuring cardiopulmonary bypass, sevoflurane will be administered through a vaporizer integrated into heart-lung-machine. |
| Isoflurane | Active comparator | Drug: IsofluraneDuring cardiopulmonary bypass, isoflurane will be administered through a vaporizer integrated into heart-lung-machine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- elective coronary bypass surgery
- preserved left ventricular function (LVEF (left ventricular ejection fraction) >55%)
- Age > 18 years
- planned MECC-System (minimized extracorporeal circulation)
- informed consent
Key exclusion criteria (10 listed)
- chronic renal insufficiency (serum creatinine > 132umol/l)
- Body Mass Index > 35kg/m2
- additional operative procedures (eg. valve replacement/reconstruction)
- recent cardiac infarction (< 7 days) or elevated cardiac enzymes the day before surgery
- previous cardiac operation
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 |
|---|---|---|
| SevofluraneAlso: Sevoranevolatile Anaesthetic, duration during cardiopulmonary bypass | Drug | Sevoflurane |
| IsofluraneAlso: Isofluranvolatile anesthetic, duration during cardiopulmonary bypass time | Drug | Isoflurane |
Primary outcome
postoperative maximum Troponin levels
Time frame: 24 hours
1 secondary outcome
Hemodynamic stability during on-pump
Time frame: 2 hours
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 29 Jan 2014.
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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.
Jens Fassl, MD principal investigator
University Hospital Basel Departement of Anesthesiology and Intensive care medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane and Isoflurane in people with Myocardial Reperfusion Injury, run by University Hospital, Basel, Switzerland 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 5 inclusion and 10 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 29 Jan 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
postoperative maximum Troponin levels (time frame: 24 hours). 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 29 Jan 2014.