CREATE, 2005

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A Glucose-Insulin-Potassium infusion has no additional benefit on the mortality of patients with Acute ST-Segment Elevation MI

There is no additional benefit with GIK infusion on mortality, cardiac arrest, cardiogenic shock or re-infarction at 30 days in patients with acute ST-segment elevation myocardial infarction

Level of Evidence: 1⁺ (RCT with a low risk of Bias)

Citation/s: Effect of Glucose-Insulin-potassium Infusion on Mortality in Patients with Acute ST-Segment Elevation Myocardial Infarction: JAMA vol 293 No. 4 Jan 26, 2005, 437-446

Lead author's name and fax: Shamir R. Mehta, MD, MSc, FRCPC, McMaster University and Hamilton Health Services, 237 Barton St E, Hamilton, Ontario, Canada L8L 2X2 smethta@mcmaster.ca

Three-part Clinical Question: Does insulin-glucose-potassium infusion improve mortality in patients with acute ST-segment elevation myocardial infarction?

Search Terms: randomised controlled trial, myocardial infarction and GIK infusion

The Study: Non-blinded randomised controlled trial with intention-to-treat.
The Study Patients: Patients with ST-segment Elevation MI who presented within 12 hours of symptom onset.

Control group (N = 10110; 10107 analysed): Standard ccu care alone.

Experimental group (N = 10091; 10088 analysed): Standard care plus GIK infusion for 24 hours, using an infusion of 25% glucose, 50U/L regular insulin and 80 mEq/L of potassium at a rate of 1.5mL/kg for 24hrs with adjustments made as per a standard monogram similar to that used in the ELCA pilot trial with carefully monitored fluid balance.

The Evidence:

Outcome	Time to Outcome	CER	EER	RRR	ARR	NNT
mortality	30 days	0.097	0.099	-2%	-0.002	NS
mortality	95% Confidence Intervals:			NS	NS	NS
cardiac arrest	30 days	0.015	0.014	7%	0.001	NS
cardiac arrest	95% Confidence Intervals:			NS	NS	NS
cardiogenic shock	30 days	0.063	0.066	-5%	-0.003	NS
cardiogenic shock	95% Confidence Intervals:			NS	NS	NS

EBM summary questions:

1. Do the methods allow the adequate testing of the hypothesis- Yes, this is a very large, well designed study, though blinding was limited by the nature of the intervention.

2. Do the statistical tests correctly test the results to allow differentiation of statistically significant results- Yes

3. Are the conclusions valid in light of the results- Yes, the study showed no clear additional benefit to GIK infusions in patients with STEMI.

4. Did results get omitted- No

5. Did they suggest areas of further research- Yes, (a) a possible modification to the regimen to lower and more tightly control glucose (The study did, however, show that there was a poorer outcome in those who presented with or showed a higher baseline glucose).(b) further investigation of a possible decrease in recurrent ischaemia (There was a slight reduction in recurrent ischaemia with the GIK group, though this emerged after the first 24 hours (absolute risk reduction of 0.8% in GIK group) and whether this was due to investigating reporter bias or due to an intrinsic anti-ischaemic effect of the infusion remains unaddressed by the trial).

6. Did they make recommendations based on the results and were they appropriate- Yes, there is no additional benefit to GIK infusion in the first 24hrs in STEMI

7. Is this study relevant to my clinical practice- Yes

8. What level of evidence does this study recommend- 1+

9. What grade of recommendation can I make on this result alone- B

10. What grade of recommendation can I make when this study is considered along with other available evidence- A (Though this work appears to contradict some of the findings of Van Der Berghe et al. and the DIGAMI study, the studies are not directly comparable looking at only STEMI patients and terminating the intervention after only 24 hours.)

11. Should I change my practice based on these results- No, the study was negative

12. Should I audit my current practice because of these results- Yes, though there was no benefit to GIK infusion the study did show poorer outcomes in those with raised blood glucose and an audit could be based around tighter blood glucose control.

Appraised by: Dr. Paul McConnell c/o Dept. of Anaesthesia Royal Alexandra Hospital, Corsebar Road, Paisley; 12 April 2005

Email: paulmcconnell@doctors.org.uk

Kill or Update By: June 2010.

Edited by KR & CC.

Citation: EBM Critical Appraisals. Scottish Intensive Care Society EBM Group. McConnell P. 2005. : Effect of Glucose-Insulin-potassium Infusion on Mortality in Patients with Acute ST-Segment Elevation Myocardial Infarction: JAMA. 2005 vol 293: 437-446

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