The impact of glucose-insulin-potassium infusion in acute myocardial infarction on infarct size and left ventricular ejection fraction [ISRCTN56720616]

BACKGROUND: Favorable clinical outcomes have been observed with glucose-insulin-potassium infusion (GIK) in acute myocardial infarction (MI). The mechanisms of this beneficial effect have not been delineated clearly. GIK has metabolic, anti-inflammatory and profibrinolytic effects and it may preserve the ischemic myocardium. We sought to assess the effect of GIK infusion on infarct size and left ventricular function, as part of a randomized controlled trial. METHODS: Patients (n = 940) treated for acute MI by primary percutaneous coronary intervention (PCI) were randomized to GIK infusion or no infusion. Endpoints were the creatinine kinase MB-fraction (CK-MB) and left ventricular ejection fraction (LVEF). CK-MB levels were determined 0, 2, 4, 6, 24, 48, 72 and 96 hours after admission and the LVEF was measured before discharge. RESULTS: There were no differences between the two groups in the time course or magnitude of CK-MB release: the peak CK-MB level was 249 ± 228 U/L in the GIK group and 240 ± 200 U/L in the control group (NS). The mean LVEF was 43.7 ± 11.0 % in the GIK group and 42.4 ± 11.7% in the control group (P = 0.12). A LVEF ≤ 30% was observed in 18% in the controls and in 12% of the GIK group (P = 0.01). CONCLUSION: Treatment with GIK has no effect on myocardial function as determined by LVEF and by the pattern or magnitude of enzyme release. However, left ventricular function was preserved in GIK treated patients

Protocol for the evaluation of a social franchising model to improve maternal health in Uttar Pradesh, India.

BACKGROUND: Social franchising is the fastest growing market-based approach to organising and improving the quality of care in the private sector of low- and middle-income countries, but there is limited evidence on its impact and cost-effectiveness. The "Sky" social franchise model was introduced in the Indian state of Uttar Pradesh in late 2013. METHODS/DESIGN: Difference-in-difference methods will be used to estimate the impact of the social franchise programme on the quality and coverage of health services along the continuum of care for reproductive, maternal and newborn health. Comparison clusters will be selected to be as similar as possible to intervention clusters using nearest neighbour matching methods. Two rounds of data will be collected from a household survey of 3600 women with a birth in the last 2 years and a survey of 450 health providers in the same localities. To capture the full range of effects, 59 study outcomes have been specified and then grouped into conceptually similar domains. Methods to account for multiple inferences will be used based on the pre-specified grouping of outcomes. A process evaluation will seek to understand the scale of the social franchise network, the extent to which various components of the programme are implemented and how impacts are achieved. An economic evaluation will measure the costs of setting up, maintaining and running the social franchise as well as the cost-effectiveness and financial sustainability of the programme. DISCUSSION: There is a dearth of evidence demonstrating whether market-based approaches such as social franchising can improve care in the private sector. This evaluation will provide rigorous evidence on whether an innovative model of social franchising can contribute to better population health in a low-income setting