search
Back to results

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

Primary Purpose

Aortic Stenosis, Coronary Heart Disease, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Glucose-insulin-potassium
Placebo
Sponsored by
Christoph Ellenberger
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring Cardiac surgery, Cardioprotection, Aortocoronary bypass graft, Aortic stenosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiocentro
  • Geneva University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Administration of glucose-insulin-potassium

Outcomes

Primary Outcome Measures

Postcardiotomy ventricular dysfunction

Secondary Outcome Measures

Systolic and diastolic cardiac function using transoesophageal echocardiography
Hypo-/hyperglycemia Hypo-/hyperkaliemia
Serious cardiovascular adverse events (myocardial infarction, cardiac arrhythmia, low cardiac output, stroke)
Serum troponin and creatinine kinase

Full Information

First Posted
November 7, 2008
Last Updated
November 22, 2016
Sponsor
Christoph Ellenberger
search

1. Study Identification

Unique Protocol Identification Number
NCT00788242
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christoph Ellenberger

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Coronary Heart Disease, Heart Failure
Keywords
Cardiac surgery, Cardioprotection, Aortocoronary bypass graft, Aortic stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Administration of glucose-insulin-potassium
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Glucose-insulin-potassium
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
60 ml of isotonic saline. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping
Primary Outcome Measure Information:
Title
Postcardiotomy ventricular dysfunction
Time Frame
48h postoperative
Secondary Outcome Measure Information:
Title
Systolic and diastolic cardiac function using transoesophageal echocardiography
Time Frame
intraoperative
Title
Hypo-/hyperglycemia Hypo-/hyperkaliemia
Time Frame
intraoperative
Title
Serious cardiovascular adverse events (myocardial infarction, cardiac arrhythmia, low cardiac output, stroke)
Time Frame
48 postoperative
Title
Serum troponin and creatinine kinase
Time Frame
Intraoperative - 48 h postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cardiocentro
City
Lugano
State/Province
Ticino
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Geneva University Hospital
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31492103
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs