Back to results

A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon (CArDiAX)

Primary Purpose

Xenon, Sevoflurane, Anesthetics, Inhalation

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Xenon

Sevoflurane

About this trial

This is an interventional treatment trial for Xenon focused on measuring xenon, sevoflurane, cardiac anesthesia, CABG, Bypass surgery

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with coronary artery disease scheduled for elective CABG
Patients willing and able to complete the requirements of this study
Ejection Fraction > 50%
EuroSCORE ≤ 8
men and women >= 50 yrs
women without childbearing potential
ASA Score II-IV

Exclusion Criteria:

Lack of informed consent
EuroSCORE < 8
MMSE < 24
Age < 50 years
COPD GOLD > II, increased need of oxygen
Renal dysfunction
Liver function disorders
Acute coronary syndrome during the last 24 hours; hemodynamic instability
Requirement of inotropic support
Off-pump-surgery
Disabling neuropsychiatric disorders
History of stroke with residuals
Hypersensitivity to the study anaesthetics
Increased intracranial pressure
Pregnancy and lactation period
Women of childbearing potential
Presumed uncooperativeness or legal incapacity
Participation in a concomitant trial

Sites / Locations

Department of Anesthesiology, University Hospital Aachen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Xenon

Sevoflurane

Arm Description

Xenon will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.

Sevoflurane will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.

Outcomes

Primary Outcome Measures

Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation

The feasibility of xenon application compared to sevoflurane application will be assessed by: The depth of anaesthesia level The peri-anaesthetic respiratory profile The peri-anaesthetic haemodynamic profile The following safety parameters will be assessed: Doses and concentration of study treatments Trans-esophageal echocardiography Measures of renal function Intra-operative blood loss and amount of transfused blood/products Need for hemodynamic and inotropic support The patient's regional cerebral tissue oxygenation rSO2 The incidence of AE and SAE

Secondary Outcome Measures

Secondary efficacy and safety criteria

The following secondary efficacy parameters will be assessed: the patients organ function status The severity of postoperative critical illness The incidence of Post-operative Delirium (POD) The duration of postoperative intensive care unit and in-hospital stay Secondary safety parameters: hemodynamic and respiratory profile, including vital signs incidence of major adverse cardiac and cerebral events (MACCE) laboratory parameters -post-operative pain further AE and SAE

all cause mortality and contentment questioning

Patients will be contacted by telephone one year after surgery for a one year mortality and contentment examination.

Full Information

NCT ID

NCT01285271

First Posted

January 24, 2011

Last Updated

October 5, 2011

Sponsor

RWTH Aachen University

Collaborators

German Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01285271

Brief Title

A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon

Acronym

CArDiAX

Official Title

The Safety and Feasibility of Delivering Xenon to Patients Before and After Coronary Artery Bypass Graft Implantation: a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RWTH Aachen University

Collaborators

German Research Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study is to determine whether xenon - as compared to sevoflurane - can be applied safely in patients for general anesthesia before and after CABG implantation.

Detailed Description

The study will be conducted by two investigator types: The study enrollment and the post-anesthesia follow-up will be performed by Investigator I who is blinded to the study treatment. Investigator II will only perform general anaesthesia for CABG surgery and will therefore necessarily be unblinded to the treatment conditions. Patients will be randomly assigned to one of the following study groups. Group 1 (Xenon) will receive xenon for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. Group 2 (Sevoflurane) will receive sevoflurane for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. During extracorporal circulation, general anesthesia will be maintained intravenously in both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Xenon, Sevoflurane, Anesthetics, Inhalation, Coronary Disease, Coronary Artery Bypass

Keywords

xenon, sevoflurane, cardiac anesthesia, CABG, Bypass surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Xenon

Arm Type

Experimental

Arm Description

Xenon will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.

Arm Title

Sevoflurane

Arm Type

Active Comparator

Arm Description

Sevoflurane will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.

Intervention Type

Drug

Intervention Name(s)

Xenon

Intervention Description

gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation

Intervention Type

Drug

Intervention Name(s)

Sevoflurane

Intervention Description

inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application before the start and after the end of extracorporal circulation

Primary Outcome Measure Information:

Title

Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation

Description

Time Frame

an average of 4 to 6 hours

Secondary Outcome Measure Information:

Title

Secondary efficacy and safety criteria

Description

Time Frame

6 days

Title

all cause mortality and contentment questioning

Description

Patients will be contacted by telephone one year after surgery for a one year mortality and contentment examination.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with coronary artery disease scheduled for elective CABG Patients willing and able to complete the requirements of this study Ejection Fraction > 50% EuroSCORE ≤ 8 men and women >= 50 yrs women without childbearing potential ASA Score II-IV Exclusion Criteria: Lack of informed consent EuroSCORE < 8 MMSE < 24 Age < 50 years COPD GOLD > II, increased need of oxygen Renal dysfunction Liver function disorders Acute coronary syndrome during the last 24 hours; hemodynamic instability Requirement of inotropic support Off-pump-surgery Disabling neuropsychiatric disorders History of stroke with residuals Hypersensitivity to the study anaesthetics Increased intracranial pressure Pregnancy and lactation period Women of childbearing potential Presumed uncooperativeness or legal incapacity Participation in a concomitant trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Coburn, PD Dr. med.

Organizational Affiliation

Department of Anesthesiology, University Hospital Aachen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Anesthesiology, University Hospital Aachen

City

Aachen

State/Province

NRW

ZIP/Postal Code

52074

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

26467531

Citation

Breuer T, Emontzpohl C, Coburn M, Benstoem C, Rossaint R, Marx G, Schalte G, Bernhagen J, Bruells CS, Goetzenich A, Stoppe C. Xenon triggers pro-inflammatory effects and suppresses the anti-inflammatory response compared to sevoflurane in patients undergoing cardiac surgery. Crit Care. 2015 Oct 15;19:365. doi: 10.1186/s13054-015-1082-7.

Results Reference

derived

PubMed Identifier

23578862

Citation

Stoppe C, Fahlenkamp AV, Rex S, Veeck NC, Gozdowsky SC, Schalte G, Autschbach R, Rossaint R, Coburn M. Feasibility and safety of xenon compared with sevoflurane anaesthesia in coronary surgical patients: a randomized controlled pilot study. Br J Anaesth. 2013 Sep;111(3):406-16. doi: 10.1093/bja/aet072. Epub 2013 Apr 11.

Results Reference

derived

Learn more about this trial

A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon

We'll reach out to this number within 24 hrs