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

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Brief Title

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

Official Title

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

Brief Summary

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

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

Primary Outcome

Postcardiotomy ventricular dysfunction

Secondary Outcome

 Systolic and diastolic cardiac function using transoesophageal echocardiography

Condition

Aortic Stenosis

Intervention

Glucose-insulin-potassium

Study Arms / Comparison Groups

 1
Description:  Administration of glucose-insulin-potassium

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

200

Start Date

January 2009

Completion Date

December 2013

Primary Completion Date

December 2013

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations

NCT ID

NCT00788242

Organization ID

NAC 08-032

Responsible Party

Sponsor-Investigator

Study Sponsor

Christoph Ellenberger

Study Sponsor

, ,

Verification Date

November 2016