Xenon in Off-pump Coronary Artery Bypass Graft Surgery

Coronary Artery Disease Clinical Trial

Official title:

The Safety and Feasibility of Administering Xenon to Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757106
• Other study ID #: SR052012
• Secondary ID: 2012-002316-12
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2012
• Last updated: March 24, 2014
• Start date: December 2012
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

Purpose of this study is to test whether xenon application during off-pump-coronary artery bypass (OPCAB)-surgery is safe and feasible.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with coronary artery disease scheduled for elective OPCAB- surgery

• Patients willing and able to complete the requirements of this study

• Ejection Fraction > 30%

Exclusion Criteria:

• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Xenon
general anaesthesia with xenon 50-60% in oxygen (FiO2=0.4-0.5)
• sevoflurane
general anesthesia with sevoflurane 1.4% in 50% oxygen/medical air

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other secondary efficacy/safety measures	Perioperative blood loss	up to five days after surgery	Yes
Other	Other secondary efficacy/safety measures	Requirement for blood (product) transfusion	up to five days after surgery	Yes
Other	Other secondary efficacy/safety measures	Duration of postoperative intensive care unit and hospital stay	until discharge from the hospital	No
Other	Other secondary efficacy/safety measures	Severity of postoperative critical illness as indicated by the sequential organ failure assessment (SOFA) score	up to five days after surgery	Yes
Other	Other secondary efficacy/safety measures	Perioperative renal function assessed by serum-creatinine levels and calculated creatinine clearance	up to five days after surgery	Yes
Other	other secondary efficacy/safety measures	Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II)	up to five days after surgery	No
Primary	Feasibility/Safety of xenon anesthesia	assessed by: depth of anesthesia, perioperative hemodynamic profile, peripheral and arterial oxygen saturation	Intraoperatively	Yes
Secondary	Major adverse cardiac and cerebral events (MACCE)	death from any cause; perioperative myocardial infarction and stroke	up to six months after surgery	Yes
Secondary	Incidence and duration of postoperative delirium	assessed with the Confusion Assessment Method (CAM-ICU)	up to five days after surgery	Yes