Estudios Cardiologicos Latinoamerica Glucose-Insulin-Potassium Pilot Trial - ECLA GIK

Description:

This was a multicenter, prospective, randomized, pilot, clinical trial designed to assess the feasibility of glucose and insulin with potassium (GIK) infusion in the acute phase of myocardial infarction (MI) and to assess its effect on clinical outcome.

Hypothesis:

Treatment with GIK in the acute phase of acute MI is feasible, well tolerated, and associated with improved clinical outcome.

Study Design

Study Design:

Patients Enrolled: 407
Mean Follow Up: Up to one year
Mean Patient Age: 58 SE 1.05
Female: 25

Patient Populations:

Suspected acute MI with onset of symptoms within the previous 24 hours. In 94.1% of the patients, MI was enzymatically confirmed.

Exclusions:

The absolute contraindications to GIK infusion were severe renal impairment or hyperkalemia. No other contraindications were specified by the protocol, but instead were left at the discretion of the treating physician.

Primary Endpoints:

In-hospital death, severe chronic heart failure, ventricular fibrillation, electrical mechanical dissociation, length of stay, and glucose and potassium levels

Secondary Endpoints:

Cardiogenic shock, reinfarction, coronary artery bypass graft/nonprimary PTCA, and major hemorrhage

Drug/Procedures Used:

Two GIK regimens were used: 1) high-dose GIK (25% glucose, 50 IU insulin per liter, and 80 mmol KCl per liter at an infusion rate of 1.5 ml/kg/h over 24 hours), and 2) low-dose GIK (10% glucose, 20 IU of insulin per liter, and 40 mmol of KCl per liter at an infusion rate of 1.0 ml/kg/h over 24 hours). The control group did not receive a placebo infusion.

Concomitant Medications:

Physicians were free to use whatever additional therapy was considered necessary, including reperfusion therapy (thrombolysis or primary percutaneous transluminal coronary angioplasty [PTCA]).

Principal Findings:

A total of 407 patients with acute MI were enrolled and were randomized as follows: 135 to high-dose GIK (33.2%), 133 to low-dose GIK (32.7%), and 139 to the control group (34.2%). A total of 252 patients (61.9%) were treated with a reperfusion strategy (95% received lytic therapy and 5% received primary angioplasty). Most baseline variables were well matched among the groups. Results are reported as a comparison of the combination of both GIK regimens versus control.

There was no statistically significant difference in the length of hospital stay, fluid overload, line-induced sepsis, and glucose levels between the groups. Potassium levels were higher at 24 (4.25 mmol/l vs. 4.04 mmol/l, p=0.0001) and 48 hours (4.24 mmol/l vs. 4.08 mmol/l, p=0.0027).

The overall mortality did not differ significantly between the GIK and the control groups (6.7% vs. 11.5%, p=NS); however, a trend toward a nonsignificant reduction of in-hospital events was observed in the GIK group. A significant reduction in mortality (relative risk [RR] 0.34, confidence interval [CI] 0.15-0.77, p=0.01) was observed among patients treated with reperfusion strategies in the GIK group.

A significant reduction in the composite endpoint of death, severe heart failure, and nonfatal ventricular fibrillation was observed in reperfused patients in the GIK group (RR 0.56, CI 0.31-1.01, p=0.05) and overall (both reperfused and nonreperfused patients; RR 0.59, CI 0.37-0.94, p=0.03).

Interpretation:

Among patients with acute MI, GIK infusion is feasible, safe, and easily implemented. Important endpoints such as mortality, severe heart failure, ventricular fibrillation, and electromechanical dissociation were reduced. An important limitation is the small size of the study, and these results would require confirmation in a much larger trial.

References:

Diaz R, Paolasso EA, Piegas LS, et al. Metabolic modulation of acute myocardial infarction. The ECLA (Estudios Cardiologicos Latinoamerica) Collaborative Group. Circulation 1998;98:2227-34.

Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, SCD/Ventricular Arrhythmias, Acute Heart Failure

Keywords: Insulin, Myocardial Infarction, Potassium, Sepsis, Ventricular Fibrillation, Heart Failure, Angioplasty, Glucose, Length of Stay


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