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Stroke: GKI infusion no better than standard therapy

GKI infusion in acute stroke does not lower plasma glucose better than standard therapy.

Increased risk of biochemical, but not symptomatic hypoglycaemia.

No difference in survival.

 

Level 1- evidence (RCT, but small samples, one more event either way could have big impact, small samples always limit our certainty of effects)

 

Citation/s: Scott JF, et al. Glucose Potassium Insulin Infusions in the Treatment of Acute Stroke Patients With Mild to Moderate Hyperglycaemia: The Glucose Insulin in Stroke Trial (GIST) Stroke 1999 30 (4); 793-9

 

Lead author's name and fax: Prof CS Gray, University Dept of Medicine for the Elderly, Sunderland Royal Hospital, Kayll Rd, Sunderland SR4 7TP c.s.gray@ncl.ac.uk

 

Three-part Clinical Question: Among stroke patients with hyperglycaemia, does intensive insulin therapy influence mortality?


Search Terms: Clinical Trials, Hyperglycaemia, Insulin and Stroke.

 

The Study:
Single-blinded concealed randomised controlled trial with intention-to-treat.


The Study Patients: All patients >18years of age with a clinical diagnosis of acute (within 24 hrs) stroke and a blood glucose level of 7 -17 mmol/L admitted to a DGH. Excluded if >24 hrs, CHF, Renal Failure, Anaemia, pneumonia, GCS < 4.


Control group (N = 25; 25 analysed): Standard stroke care plus 500ml 154mmol/L (Normal) saline at 100ml/hr through a peripheral vein in the non-paretic arm for a minimum of 24 hours. All antihypertensive medication was discontinued on admission.


Experimental group (N = 25; 25 analysed): Standard stroke care plus 500ml 10% Dextrose with 16U insulin & 20mmol KCl at 100ml/h through a peripheral vein in the non-paretic arm for 24hrs. Monitoring & blood tests were identical for each infusate. After the initial 24hrs, patients were maintained on the GKI, on saline or on no fluids as clinical needs dictated. Clinical assessments were undertaken by 1 of 2 observers at randomisation, at 24 hrs, 48 hrs, 7days & 4 weeks.

 

The Evidence:

Outcome

Time to Outcome

CER

EER

RRR

ARR

NNT

Mortality

4 weeks

0.320

0.280

12%

0.040

25

95% Confidence Intervals:

-67% to 92%

-0.214 to 0.294

¥ = no effect

Asymptomatic hypoglycaemia

24 hours

0

0.160

INF

-0.160

-6

95% Confidence Intervals:

 

-0.304 to -0.016

-61 to -3

Symptomatic hypoglycaemia

24 hours

0

0.040

INF

-0.040

-25

95% Confidence Intervals:

 

-0.117 to 0.037

¥ = no effect

 

Comments:

1. No clear benefit from GKI in stroke and hyperglycaemia.   No difference in blood sugar compared to control group.

 

2. No impact on clinically important end-points.   Certainty is always limited in small trials.

 

3. Bedside BM testing corresponds closely to formal plasma samples.

 

4. Negative NNT indicates increased risk of this outcome in GKI group.

Appraised by: Kevin Rooney, Dept of Anaesthesia & Intensive Care Medicine, Royal Alexandra Hospital, Paisley; 30 December 2002    Email: kd.rooney@virgin.net
Kill or Update By: December 2004

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