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Completed

NCT Number: NCT00788242

The Effect of Glucose-Insulin-Potassium Infusion 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiocentro, Lugano, Canton Ticino, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose-insulin-potassium

Drug

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

Placebo

Drug

60 ml of isotonic saline. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping

Primary outcomes

  1. Postcardiotomy ventricular dysfunction

    Time frame: 48h postoperative

Secondary outcomes

  1. Systolic and diastolic cardiac function using transoesophageal echocardiography

    Time frame: intraoperative

  2. Hypo-/hyperglycemia Hypo-/hyperkaliemia

    Time frame: intraoperative

  3. Serious cardiovascular adverse events (myocardial infarction, cardiac arrhythmia, low cardiac output, stroke)

    Time frame: 48 postoperative

  4. Serum troponin and creatinine kinase

    Time frame: Intraoperative - 48 h postoperative

Sponsors and collaborators

Lead sponsor

Christoph Ellenberger

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Nov 10, 2008
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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