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  1. Article ; Online: One-year outcomes of out-of-hospital administration of intravenous glucose, insulin, and potassium (GIK) in patients with suspected acute coronary syndromes (from the IMMEDIATE [Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care] Trial).

    Selker, Harry P / Udelson, James E / Massaro, Joseph M / Ruthazer, Robin / D'Agostino, Ralph B / Griffith, John L / Sheehan, Patricia R / Desvigne-Nickens, Patrice / Rosenberg, Yves / Tian, Xin / Vickery, Ellen M / Atkins, James M / Aufderheide, Tom P / Sayah, Assaad J / Pirrallo, Ronald G / Levy, Michael K / Richards, Michael E / Braude, Darren A / Doyle, Delanor D /
    Frascone, Ralph J / Kosiak, Donald J / Leaming, James M / Van Gelder, Carin M / Walter, Gert-Paul / Wayne, Marvin A / Woolard, Robert H / Beshansky, Joni R

    The American journal of cardiology

    2014  Volume 113, Issue 10, Page(s) 1599–1605

    Abstract: The Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care Trial of very early intravenous glucose-insulin-potassium (GIK) for acute coronary syndromes (ACS) in out-of-hospital emergency medical service (EMS) ...

    Abstract The Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care Trial of very early intravenous glucose-insulin-potassium (GIK) for acute coronary syndromes (ACS) in out-of-hospital emergency medical service (EMS) settings showed 80% reduction in infarct size at 30 days, suggesting potential longer-term benefits. Here we report 1-year outcomes. Prespecified 1-year end points of this randomized, placebo-controlled, double-blind, effectiveness trial included all-cause mortality and composites including cardiac arrest, mortality, or hospitalization for heart failure (HF). Of 871 participants randomized to GIK versus placebo, death occurred within 1 year in 11.6% versus 13.5%, respectively (unadjusted hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.57 to 1.23, p = 0.36). The composite of cardiac arrest or 1-year mortality was 12.8% versus 17.0% (HR 0.71, 95% CI 0.50 to 1.02, p = 0.06). The composite of hospitalization for HF or mortality within 1 year was 17.2% versus 17.2% (HR 0.98, 95% CI 0.70 to 1.37, p = 0.92). The composite of mortality, cardiac arrest, or HF hospitalization within 1 year was 18.1% versus 20.4% (HR 0.85, 95% CI 0.62 to 1.16, p = 0.30). In patients presenting with suspected ST elevation myocardial infarction, HRs for 1-year mortality and the 3 composites were, respectively, 0.65 (95% CI 0.33 to 1.27, p = 0.21), 0.52 (95% CI 0.30 to 0.92, p = 0.03), 0.63 (95% CI 0.35 to 1.16, p = 0.14), and 0.51 (95% CI 0.30 to 0.87, p = 0.01). In patients with suspected acute coronary syndromes, serious end points generally were lower with GIK than placebo, but the differences were not statistically significant. However, in those with ST elevation myocardial infarction, the composites of cardiac arrest or 1-year mortality, and of cardiac arrest, mortality, or HF hospitalization within 1 year, were significantly reduced.
    MeSH term(s) Acute Coronary Syndrome/diagnosis ; Acute Coronary Syndrome/drug therapy ; Acute Coronary Syndrome/mortality ; Adult ; After-Hours Care/methods ; Cardioplegic Solutions ; Cause of Death/trends ; Double-Blind Method ; Electrocardiography ; Female ; Follow-Up Studies ; Glucose/administration & dosage ; Heart Arrest/mortality ; Heart Arrest/prevention & control ; Humans ; Infusions, Intravenous ; Insulin/administration & dosage ; Male ; Middle Aged ; Myocardium/metabolism ; Outpatients ; Potassium/administration & dosage ; Retrospective Studies ; Survival Rate/trends ; Time Factors ; Treatment Outcome ; United States/epidemiology
    Chemical Substances Cardioplegic Solutions ; Insulin ; glucose-insulin-potassium cardioplegic solution ; Glucose (IY9XDZ35W2) ; Potassium (RWP5GA015D)
    Language English
    Publishing date 2014-03-01
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
    ZDB-ID 80014-4
    ISSN 1879-1913 ; 0002-9149
    ISSN (online) 1879-1913
    ISSN 0002-9149
    DOI 10.1016/j.amjcard.2014.02.010
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Out-of-hospital administration of intravenous glucose-insulin-potassium in patients with suspected acute coronary syndromes: the IMMEDIATE randomized controlled trial.

    Selker, Harry P / Beshansky, Joni R / Sheehan, Patricia R / Massaro, Joseph M / Griffith, John L / D'Agostino, Ralph B / Ruthazer, Robin / Atkins, James M / Sayah, Assaad J / Levy, Michael K / Richards, Michael E / Aufderheide, Tom P / Braude, Darren A / Pirrallo, Ronald G / Doyle, Delanor D / Frascone, Ralph J / Kosiak, Donald J / Leaming, James M / Van Gelder, Carin M /
    Walter, Gert-Paul / Wayne, Marvin A / Woolard, Robert H / Opie, Lionel H / Rackley, Charles E / Apstein, Carl S / Udelson, James E

    JAMA

    2012  Volume 307, Issue 18, Page(s) 1925–1933

    Abstract: Context: Laboratory studies suggest that in the setting of cardiac ischemia, immediate intravenous glucose-insulin-potassium (GIK) reduces ischemia-related arrhythmias and myocardial injury. Clinical trials have not consistently shown these benefits, ... ...

    Abstract Context: Laboratory studies suggest that in the setting of cardiac ischemia, immediate intravenous glucose-insulin-potassium (GIK) reduces ischemia-related arrhythmias and myocardial injury. Clinical trials have not consistently shown these benefits, possibly due to delayed administration.
    Objective: To test out-of hospital emergency medical service (EMS) administration of GIK in the first hours of suspected acute coronary syndromes (ACS).
    Design, setting, and participants: Randomized, placebo-controlled, double-blind effectiveness trial in 13 US cities (36 EMS agencies), from December 2006 through July 31, 2011, in which paramedics, aided by electrocardiograph (ECG)-based decision support, randomized 911 (871 enrolled) patients (mean age, 63.6 years; 71.0% men) with high probability of ACS.
    Intervention: Intravenous GIK solution (n = 411) or identical-appearing 5% glucose placebo (n = 460) administered by paramedics in the out-of-hospital setting and continued for 12 hours.
    Main outcome measures: The prespecified primary end point was progression of ACS to myocardial infarction (MI) within 24 hours, as assessed by biomarkers and ECG evidence. Prespecified secondary end points included survival at 30 days and a composite of prehospital or in-hospital cardiac arrest or in-hospital mortality, analyzed by intent-to-treat and by presentation with ST-segment elevation.
    Results: There was no significant difference in the rate of progression to MI among patients who received GIK (n = 200; 48.7%) vs those who received placebo (n = 242; 52.6%) (odds ratio [OR], 0.88; 95% CI, 0.66-1.13; P = .28). Thirty-day mortality was 4.4% with GIK vs 6.1% with placebo (hazard ratio [HR], 0.72; 95% CI, 0.40-1.29; P = .27). The composite of cardiac arrest or in-hospital mortality occurred in 4.4% with GIK vs 8.7% with placebo (OR, 0.48; 95% CI, 0.27-0.85; P = .01). Among patients with ST-segment elevation (163 with GIK and 194 with placebo), progression to MI was 85.3% with GIK vs 88.7% with placebo (OR, 0.74; 95% CI, 0.40-1.38; P = .34); 30-day mortality was 4.9% with GIK vs 7.7% with placebo (HR, 0.63; 95% CI, 0.27-1.49; P = .29). The composite outcome of cardiac arrest or in-hospital mortality was 6.1% with GIK vs 14.4% with placebo (OR, 0.39; 95% CI, 0.18-0.82; P = .01). Serious adverse events occurred in 6.8% (n = 28) with GIK vs 8.9% (n = 41) with placebo (P = .26).
    Conclusions: Among patients with suspected ACS, out-of-hospital administration of intravenous GIK, compared with glucose placebo, did not reduce progression to MI. Compared with placebo, GIK administration was not associated with improvement in 30-day survival but was associated with lower rates of the composite outcome of cardiac arrest or in-hospital mortality.
    Trial registration: clinicaltrials.gov Identifier: NCT00091507.
    MeSH term(s) Acute Coronary Syndrome/drug therapy ; Acute Coronary Syndrome/mortality ; Aged ; Allied Health Personnel ; Angina, Unstable/complications ; Angina, Unstable/drug therapy ; Cardioplegic Solutions/therapeutic use ; Decision Support Techniques ; Double-Blind Method ; Electrocardiography ; Emergency Medical Services ; Female ; Glucose/therapeutic use ; Heart Arrest/prevention & control ; Hospital Mortality ; Humans ; Insulin/therapeutic use ; Male ; Middle Aged ; Myocardial Infarction/etiology ; Myocardial Infarction/prevention & control ; Odds Ratio ; Potassium/therapeutic use ; Survival Analysis ; Treatment Outcome
    Chemical Substances Cardioplegic Solutions ; Insulin ; glucose-insulin-potassium cardioplegic solution ; Glucose (IY9XDZ35W2) ; Potassium (RWP5GA015D)
    Language English
    Publishing date 2012-03-27
    Publishing country United States
    Document type Clinical Trial ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2012.426
    Database MEDical Literature Analysis and Retrieval System OnLINE

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