High Sensitive Troponin T ReleaseNCT02217319
Cardioprotection by Sevoflurane Preconditioning in Noncardiac Thoracic Surgery
A study testing Sevoflurane and TIVA in people with High Sensitive Troponin T Release, run by Dr. Horst Schmidt Klinik GmbH at 1 site in Germany.
Trial summary
It has been shown that the use of volatile anaesthetics, that are usually used to perform a general anesthesia, have cardioprotective properties. This has been shown in animal studies and in patients that underwent cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Sensitive Troponin T Release
- What is being tested?
- Sevoflurane and TIVA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Sep 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lung surgery
- ASA (American Society of Anesthesiologists) physical status 1-3
Who cannot join
- Disposition for malignant hyperthermia
- Medication with ß-blocking drugs
- Use of clonidin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Sevoflurane Preconditioning Have Cardioprotective Properties in Noncardiac Thoracic Surgery?
It has been shown that the use of volatile anaesthetics, that are usually used to perform a general anesthesia, have cardioprotective properties. This has been shown in animal studies and in patients that underwent cardiac surgery. The aim of our study is to examine if Sevoflurane, a volatile anaesthetic, has this properties in patients undergoing lung surgery.
- Conditions
- High Sensitive Troponin T Release
- Being tested
- Sevoflurane, TIVA
- Keywords
- Volatile Anesthetic, Cardioprotection, Lung surgery, non cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Anaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min). After induction of anesthesia the propofol infusion is stopped and patients receive 1 MAC Sevoflurane over 30 min. Then the propofol infusion is restarted and Sevoflurane is washed out.
TIVADrug
Also called Placebo, Controll
Anaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min).
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Active comparator | Patients receive Sevoflurane 1 MAC (minimal alveolar concentration) after induction of anesthesia with propofol, remifentanil and atracurium for 30 minutes as preconditioning. Receives: Drug: Sevoflurane |
| TIVA | Placebo comparator | Patients received the standard total intravenous anesthesia (TIVA) with propofol, remifentanil and atracurium. Receives: Drug: TIVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin T
assessing a change in high sensitive Troponin T (5th generation) Level before and at six time points after surgery (right after surgery, every 8 hours up to 40 hours after surgery)
Measured: change of Troponin T levels preoperative and postoperative up to 40 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Sensitive Troponin T ReleaseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217319
- Sponsor's protocol ID
- HSK005
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2014
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Sevoflurane Preconditioning Have Cardioprotective Properties in Noncardiac Thoracic Surgery?
- ClinicalTrials.gov ID
- NCT02217319
- Acronym / sponsor ID
- HSK005
- Conditions
- High Sensitive Troponin T Release
- Keywords
- Volatile Anesthetic, Cardioprotection, Lung surgery, non cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 15 Aug 2014 (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.
It has been shown that the use of volatile anaesthetics, that are usually used to perform a general anesthesia, have cardioprotective properties. This has been shown in animal studies and in patients that underwent cardiac surgery. The aim of our study is to examine if Sevoflurane, a volatile anaesthetic, has this properties in patients undergoing lung surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Active comparator | Drug: SevofluranePatients receive Sevoflurane 1 MAC (minimal alveolar concentration) after induction of anesthesia with propofol, remifentanil and atracurium for 30 minutes as preconditioning. |
| TIVA | Placebo comparator | Drug: TIVAPatients received the standard total intravenous anesthesia (TIVA) with propofol, remifentanil and atracurium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Lung surgery
- ASA (American Society of Anesthesiologists) physical status 1-3
Key exclusion criteria (3 listed)
- Disposition for malignant hyperthermia
- Medication with ß-blocking drugs
- Use of clonidin
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 |
|---|---|---|
| SevofluraneAnaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min). After induction of anesthesia the propofol infusion is stopped and patients receive 1 MAC Sevoflurane over 30 min. Then the propofol infusion is restarted and Sevoflurane is washed out. | Drug | Sevoflurane |
| TIVAAlso: Placebo, ControllAnaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min). | Drug | TIVA |
Primary outcome
Troponin T
Time frame: change of Troponin T levels preoperative and postoperative up to 40 hours after surgery
assessing a change in high sensitive Troponin T (5th generation) Level before and at six time points after surgery (right after surgery, every 8 hours up to 40 hours after 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 Aug 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 TIVA in people with High Sensitive Troponin T Release, run by Dr. Horst Schmidt Klinik GmbH at 1 site in Germany.
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 2 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 3 Aug 2016. 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 Germany. 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.
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?
Troponin T (time frame: change of Troponin T levels preoperative and postoperative up to 40 hours after 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 Aug 2016.