The Effect of Glucose-Insulin-Potassium Infusion in Patients Undergoing Cardiac Surgery

November 22, 2016 updated by: Christoph Ellenberger

The Effect of Glucose-Insulin-Potassium Infusion on Myocardial Injuries and Cardiac Function in Patients Undergoing Cardiac Surgery

The purpose of this study is to evaluate the cardioprotective effects of a short term infusion of glucose-insulin-potassium (GIK) during heart surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cardiac surgery with cardiopulmonary bypass and ischemic cardiac arrest is associated with a wide spectrum of perioperative myocardial ischemic-reperfusion injuries resulting in significant cardiac morbidity, namely contractile dysfunction, myocardial infarction, and low cardiac output syndrome requiring prolonged intensive care and hospital stay. The infusion of glucose-insulin-potassium (GIK) is one of the oldest cardioprotective interventions during cardiac surgery. Although experimental evidence is strong, clinical data remain conflicting. We will investigate the impact of short term GIK on the extent of myocardial injuries as well as on the left-ventricular systolic and diastolic function in 2 high-risk groups of cardiac surgical patients: Patients with cardiac dysfunction undergoing aortocoronary bypass surgery and patients with severe aortic stenosis.

Study Type

Interventional

Enrollment (Actual)

200

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
      • Geneva, Switzerland, 1211
        • Geneva University Hospital
    • Ticino
      • Lugano, Ticino, Switzerland, 6900
        • Cardiocentro

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

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Severe aortic stenosis
  • Coronary artery disease associated with poor left ventricular function
  • Parsonnet score >7

Exclusion Criteria:

  • Dementia or inability to understand the study protocol
  • Off-pump and emergent cardiac surgery
  • Poorly controlled diabetes mellitus
  • Severe renal insufficiency
  • Abnormal liver function Child-Plugh - C
  • Body Mass Index < 18 and > 35

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: Placebo
60 ml of isotonic saline. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping
EXPERIMENTAL: 1
Administration of glucose-insulin-potassium
Drug: Glucose-insulin-potassium
20 IU of insulin and 10 mM of KCl mixed with 50 ml of 40% Glucose. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postcardiotomy ventricular dysfunction
Time Frame: 48h postoperative
48h postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Systolic and diastolic cardiac function using transoesophageal echocardiography
Time Frame: intraoperative
intraoperative
Hypo-/hyperglycemia Hypo-/hyperkaliemia
Time Frame: intraoperative
intraoperative
Serious cardiovascular adverse events (myocardial infarction, cardiac arrhythmia, low cardiac output, stroke)
Time Frame: 48 postoperative
48 postoperative
Serum troponin and creatinine kinase
Time Frame: Intraoperative - 48 h postoperative
Intraoperative - 48 h postoperative

Collaborators and Investigators

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

Sponsor

Christoph Ellenberger

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

January 1, 2009

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

November 7, 2008

First Posted (ESTIMATE)

November 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 23, 2016

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAC 08-032

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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