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

NCT ID: NCT00788242

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Aortic Stenosis Coronary Heart Disease Heart Failure

Keywords

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Cardiac surgery Cardioprotection Aortocoronary bypass graft Aortic stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Administration of glucose-insulin-potassium

Group Type EXPERIMENTAL

Glucose-insulin-potassium

Intervention Type 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

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Christoph Ellenberger

OTHER

Sponsor Role lead

Responsible Party

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Christoph Ellenberger

Médecin Adjoint

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Geneva University Hospital

Geneva, Canton of Geneva, Switzerland

Site Status

Cardiocentro

Lugano, Canton Ticino, Switzerland

Site Status

Countries

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Switzerland

References

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Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.

Reference Type DERIVED
PMID: 37526194 (View on PubMed)

Licker M, Diaper J, Sologashvili T, Ellenberger C. Glucose-insulin-potassium improves left ventricular performances after aortic valve replacement: a secondary analysis of a randomized controlled trial. BMC Anesthesiol. 2019 Sep 6;19(1):175. doi: 10.1186/s12871-019-0845-0.

Reference Type DERIVED
PMID: 31492103 (View on PubMed)

Other Identifiers

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NAC 08-032

Identifier Type: -

Identifier Source: org_study_id