Coronary Artery DiseasePhase 2NCT01757106
Xenon in Off-pump Coronary Artery Bypass Graft Surgery
A Phase 2 study testing Xenon and sevoflurane in people with Coronary Artery Disease and Anesthesia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Purpose of this study is to test whether xenon application during off-pump-coronary artery bypass (OPCAB)-surgery is safe and feasible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Anesthesia
- What is being tested?
- Xenon and sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2012to Jan 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with coronary artery disease scheduled for elective OPCAB- surgery
- Patients willing and able to complete the requirements of this study
- Ejection Fraction > 30%
Who cannot join
- Lack of informed consent
- Age < 18 years
- Pregnancy
- chronic obstructive pulmonary disease (COPD) GOLD > II
- Renal dysfunction defined as serum-creatinine > 1.5 mg/dl
- Acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support
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- Single vessel grafting
- Disabling neuropsychiatric disorders (severe dementia, Alzheimer's disease, schizophrenia, depression), history of stroke with residuals, significant stenosis of carotid arteries, increased intracranial pressure
- Hypersensitivity to the study medication
- Presumed uncooperativeness or legal incapacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Feasibility of Administering Xenon to Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: a Pilot Study
Purpose of this study is to test whether xenon application during off-pump-coronary artery bypass (OPCAB)-surgery is safe and feasible.
Read the detailed description
The investigators hypothesize that xenon application during OPCAB-surgery performs non-inferiorly to the administration of the established anaesthetic sevoflurane with regard to haemodynamic stability, respiratory function, and depth of anesthesia. The evaluation of the outcome will include several secondary parameters such as the incidence of post-operative cardiovascular and neurovascular events, the incidence of organ dysfunction and further adverse events.
This study will further function as a pilot study for the evaluation of the incidence of postoperative delirium (POD) following OPCAB-surgery and xenon treatment. POD is a common complication of cardiac surgery/anaesthesia and may significantly affect the patients' mortality and outcome. Xenon possesses neuroprotective and anti-inflammatory qualities that may directly interfere with the pathogenesis of POD, as well as reducing other factors of perioperative organ injury including cardiac complications. Xenon´s favourable pharmacokinetic properties further result in rapid clearance from the brain, reducing any residual anaesthetic effects that may predispose to POD.
- Conditions
- Coronary Artery Disease, Anesthesia
- Being tested
- Xenon, sevoflurane
- Keywords
- xenon anesthesia, sevoflurane anesthesia, off-pump coronary artery bypass graft surgery
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenonDrug
general anaesthesia with xenon 50-60% in oxygen (FiO2=0.4-0.5)
sevofluraneDrug
general anesthesia with sevoflurane 1.4% in 50% oxygen/medical air
| Study group | Role | What they receive |
|---|---|---|
| Drug: Xenon | Experimental | gaseous anesthetic, dosage: 50-60% (v/v) in oxygen, continuous application during surgery Receives: Drug: Xenon |
| Drug: Sevoflurane | Active comparator | inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application during surgery Receives: Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility/Safety of xenon anesthesia
assessed by: depth of anesthesia, perioperative hemodynamic profile, peripheral and arterial oxygen saturation
Measured: Intraoperatively
Secondary outcomes (2)
Major adverse cardiac and cerebral events (MACCE)
death from any cause; perioperative myocardial infarction and stroke
Measured: up to six months after surgery
Incidence and duration of postoperative delirium
assessed with the Confusion Assessment Method (CAM-ICU)
Measured: up to five days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJul 2013
- Study completionJan 2014
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 Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof Dr Steffen Rex, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Steffen Rex, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757106
- Sponsor's protocol ID
- SR052012
- Other IDs
- 2012-002316-12
- Status last verified
- Mar 2014
- First submitted
- 3 Dec 2012
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Al Tmimi L, Van Hemelrijck J, Van de Velde M, Sergeant P, Meyns B, Missant C, Jochmans I, Poesen K, Coburn M, Rex S. Xenon anaesthesia for patients undergoing off-pump coronary artery bypass graft surgery: a prospective randomized controlled pilot trial. Br J Anaesth. 2015 Oct;115(4):550-9. doi: 10.1093/bja/aev303.
PubMed 26385664
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Feasibility of Administering Xenon to Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT01757106
- Acronym / sponsor ID
- SR052012
- Conditions
- Coronary Artery Disease, Anesthesia
- Keywords
- xenon anesthesia, sevoflurane anesthesia, off-pump coronary artery bypass graft surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 28 Dec 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.
Purpose of this study is to test whether xenon application during off-pump-coronary artery bypass (OPCAB)-surgery is safe and feasible.
Detailed description
The investigators hypothesize that xenon application during OPCAB-surgery performs non-inferiorly to the administration of the established anaesthetic sevoflurane with regard to haemodynamic stability, respiratory function, and depth of anesthesia. The evaluation of the outcome will include several secondary parameters such as the incidence of post-operative cardiovascular and neurovascular events, the incidence of organ dysfunction and further adverse events.
This study will further function as a pilot study for the evaluation of the incidence of postoperative delirium (POD) following OPCAB-surgery and xenon treatment. POD is a common complication of cardiac surgery/anaesthesia and may significantly affect the patients' mortality and outcome. Xenon possesses neuroprotective and anti-inflammatory qualities that may directly interfere with the pathogenesis of POD, as well as reducing other factors of perioperative organ injury including cardiac complications. Xenon´s favourable pharmacokinetic properties further result in rapid clearance from the brain, reducing any residual anaesthetic effects that may predispose to POD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Xenon | Experimental | Drug: Xenongaseous anesthetic, dosage: 50-60% (v/v) in oxygen, continuous application during surgery |
| Drug: Sevoflurane | Active comparator | Drug: sevofluraneinhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with coronary artery disease scheduled for elective OPCAB- surgery
- Patients willing and able to complete the requirements of this study
- Ejection Fraction > 30%
Key exclusion criteria (10 listed)
- Lack of informed consent
- Age < 18 years
- Pregnancy
- chronic obstructive pulmonary disease (COPD) GOLD > II
- Renal dysfunction defined as serum-creatinine > 1.5 mg/dl
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 |
|---|---|---|
| Xenongeneral anaesthesia with xenon 50-60% in oxygen (FiO2=0.4-0.5) | Drug | Drug: Xenon |
| sevofluranegeneral anesthesia with sevoflurane 1.4% in 50% oxygen/medical air | Drug | Drug: Sevoflurane |
Primary outcome
Feasibility/Safety of xenon anesthesia
Time frame: Intraoperatively
assessed by: depth of anesthesia, perioperative hemodynamic profile, peripheral and arterial oxygen saturation
2 secondary outcomes
Major adverse cardiac and cerebral events (MACCE)
Time frame: up to six months after surgery
Incidence and duration of postoperative delirium
Time frame: up to five days 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 26 Mar 2014.
- Derived from this study: PubMed 26385664Al Tmimi L, Van Hemelrijck J, Van de Velde M, Sergeant P, Meyns B, Missant C, Jochmans I, Poesen K, Coburn M, Rex S. Xenon anaesthesia for patients undergoing off-pump coronary artery bypass graft surgery: a prospective randomized controlled pilot trial. Br J Anaesth. 2015 Oct;115(4):550-9. doi: 10.1093/bja/aev303.
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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.
Steffen Rex, PhD principal investigator
UZ Leuven
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 Xenon and sevoflurane in people with Coronary Artery Disease and Anesthesia, run by Universitaire Ziekenhuizen KU Leuven 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 3 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 26 Mar 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 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. 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?
Feasibility/Safety of xenon anesthesia (time frame: Intraoperatively). 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 NCT01757106, 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 26 Mar 2014.