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Sevoflurane and Isoflurane - During Cardiopulmonary Bypass With the MECC System (Minimized Extracorporeal Circuit)

Primary Purpose

Myocardial Reperfusion Injury

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Sevoflurane
Isoflurane
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Reperfusion Injury focused on measuring Cardioprotection

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • University Hospital of Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sevoflurane

Isoflurane

Arm Description

During cardiopulmonary bypass, sevoflurane will be administered through a vaporizer integrated into heart-lung-machine.

During cardiopulmonary bypass, isoflurane will be administered through a vaporizer integrated into heart-lung-machine.

Outcomes

Primary Outcome Measures

postoperative maximum Troponin levels

Secondary Outcome Measures

Hemodynamic stability during on-pump

Full Information

First Posted
May 2, 2012
Last Updated
January 28, 2014
Sponsor
University Hospital, Basel, Switzerland
Collaborators
University of Leipzig, RWTH Aachen University, Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT01601795
Brief Title
Sevoflurane and Isoflurane - During Cardiopulmonary Bypass With the MECC System (Minimized Extracorporeal Circuit)
Official Title
Sevoflurane and Isoflurane - Cardioprotective Effects, Hemodynamic Stability and Pharmacokinetics During Cardiopulmonary Bypass With the MECC System
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
University of Leipzig, RWTH Aachen University, Penn State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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: A) 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. B) Washin and Washout Kinetic Kinetics of washin and washout of sevoflurane and isoflurane during CPB will be investigated and described. C) 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. D) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Reperfusion Injury
Keywords
Cardioprotection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm Description
During cardiopulmonary bypass, sevoflurane will be administered through a vaporizer integrated into heart-lung-machine.
Arm Title
Isoflurane
Arm Type
Active Comparator
Arm Description
During cardiopulmonary bypass, isoflurane will be administered through a vaporizer integrated into heart-lung-machine.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Sevorane
Intervention Description
volatile Anaesthetic, duration during cardiopulmonary bypass
Intervention Type
Drug
Intervention Name(s)
Isoflurane
Other Intervention Name(s)
Isofluran
Intervention Description
volatile anesthetic, duration during cardiopulmonary bypass time
Primary Outcome Measure Information:
Title
postoperative maximum Troponin levels
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Hemodynamic stability during on-pump
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Fassl, MD
Organizational Affiliation
University Hospital Basel Departement of Anesthesiology and Intensive care medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

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Sevoflurane and Isoflurane - During Cardiopulmonary Bypass With the MECC System (Minimized Extracorporeal Circuit)

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