Optimization of Cardioprotection in Diabetic Patients Undergoing Cardiac Surgery (OPT)

March 8, 2018 updated by: Christoph K Hofer, Triemli Hospital

Optimierung Der Kardioprotektion Durch Inhalative Anästhetika Eine Untersuchung Bei Patienten Mit Diabetes Mellitus während Off-pump Herzchirurgie

This study evaluates the myocardial protection against perioperative ischemia comparing two standard anesthetic regimes in diabetic patients undergoing elective cardiac surgery. Half of the patients will receive volatile anesthesia while the other half will receive total intravenous anesthesia. Primary and secondary outcome parameters will be assessed after induction of anesthesia, at the end of the procedure and postoperative day 1 to 3.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Volatile anaesthetics such as Sevoflurane have shown to have a protective effect regarding myocardial ischemia in the perioperative setting - the so-called "preconditioning". However the observed response of preconditioning in clinical trials is not consistent.

An increased perioperative insulin resistance especially in diabetic patients resulting in an increased postoperative morbidity and mortality may be responsible for these findings.

In an animal model, the use of propofol that is being routinely applied for general anesthesia was associated with a change of the insulin receptor substrate via phosphorylation and thus a change of insulin resistance.

Avoiding a total intravenous anesthesia and applying a volatile anesthesia may result in an increased cardioprotective effect by a reduction of the perioperative insulin resistance.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8063
        • Triemli City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Diabetes
  • Elective cardiac surgery

Exclusion Criteria:

  • Emergency procedures
  • Preop myocardial infarction
  • Preop cardiac failure
  • Preop renal replacement therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sevoflurane
Volatile anesthesia for elective cardiac surgery
Drug: Sevoflurane
Volatile anesthesia is a clinical standard procedure
Active Comparator: Propofol
Total intravenous anesthesia for elective cardiac surgery
Drug: Propofol
Total intravenous anesthesia is a clinical standard procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker NT-proBNP
Time Frame: 1. after induction of anesthesia 2. after chest closure 3.-5. postoperative day 1, day 2, day 3
Difference between volatile anesthesia and total intravenous anesthesia
1. after induction of anesthesia 2. after chest closure 3.-5. postoperative day 1, day 2, day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receptor Substrate phosphorylization (IRS-1)/PP2A
Time Frame: 1. beginning of cardiac surgery, 2. end of cardiac surgery
Difference between volatile anesthesia and total intravenous anesthesia
1. beginning of cardiac surgery, 2. end of cardiac surgery
Expression of TNF/IL1beta and microRNA (miR144, miR125b, miR208a)
Time Frame: 1. beginning of cardiac surgery, 2. end of cardiac surgery
Difference between volatile anesthesia and total intravenous anesthesia
1. beginning of cardiac surgery, 2. end of cardiac surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Triemli Hospital

Collaborators

University of Alberta

Investigators

  • Study Chair: Andreas Zollinger, MD, Institute of Anesthesiology and Intensive Care Medicine Triemli City Hospital Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

March 7, 2018

Study Completion (Actual)

March 7, 2018

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

April 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STZ-IFA-0115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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