To optimize a safe five-day intensive intravenous insulin treatment post stroke and to assess glucose profiles in patients with stroke and HG on admission, receiving standard continues enteral tube feeding.
ID
Source
Brief title
Condition
- Other condition
- Embolism and thrombosis
Synonym
Health condition
hyperglycemia
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Glucose profiles: area under the curve (AUC) > 6.1 mmol/l and AUC <4.4 mmol/l.
Secondary outcome
1) Time needed to perform all actions necessary for intensive insulin treatment.
2) Adverse reactions
a) Hypoglycemic episodes
b) Incidence of aspiration pneumonia
c) Infection or skin irritation at the site of tube insertion
Background summary
Post stroke hyperglycemia (HG) has been reported to negatively influence
cerebral infarction size, infarct progression and clinical outcome in several
series. In non-stroke, prolonged intensive insulin therapy greatly reduces
mortality in diabetic patients with acute myocardial infarction and in both
diabetic and non diabetic intensive care patients and patients undergoing
coronary artery bypass graft surgery. The use of intensive insulin therapy in
acute stroke is currently under investigation. Preliminary results indicated a
positive, but not significant effect on neurological function. In this trial
however patients are treated for only 24h. Both experimental and in vivo
studies have shown that in cerebral ischemia the infarct core is surrounded by
a rim of viable tissue at risk of infarction: the penumbra. The penumbra is
potentially salvageable but further necrosis is also possible. Recruitment of
this viable tissue into the infarct core has been related to HG. The penumbra
can persist until five days post stroke. Lack of a significant improvement with
glycemic control for 24h only could therefore be explained by insufficient
duration of insulin treatment post stroke. Prolonged glycemic control in
patients with stroke however is not easy to accomplish. As reported by others
and from experience in a recent study we performed, especially postprandial
glucoses surges are difficult to control. Continuous enteral feeding with a
stable flow of nutritional input rather than unlimited access to food supplies
therefore has the potential to greatly facilitate prolonged intensive insulin
treatment in this patient group.
Study objective
To optimize a safe five-day intensive intravenous insulin treatment post stroke
and to assess glucose profiles in patients with stroke and HG on admission,
receiving standard continues enteral tube feeding.
Study design
This is a multi centre pilot study. Blinding is not possible due to the nature
of the treatment. We will include 15-20 patients. All patients will receive
continuous enteral tube feeding and intravenous insulin aiming at plasma
glucose values between 4.4 mmol/l and 6.1 mmol/l for five consecutive days.
Glucose values will be monitored by serial venous glucose measurements using a
bedside Hemocue analyzer. We will use a modified protocol that proved to be
successful in maintaining blood glucose levels safely between 4.4 - 6.1 mmol/L
in previous trials
Intervention
1) Intraveneus insulin
2) Enteral tube feeding
Study burden and risks
Hypoglycemia
The main side effect of intensive insulin therapy is hypoglycemia. Mild
hypoglycemia for a short period does not cause any damage in healthy
individuals. Prolonged severe hypoglycemia caused by excessive insulin
administration in normal individuals can cause neurological damage leading to
convulsions, coma and death. Convulsions and coma can be seen in normal human
subjects with plasma glucose levels lower than 1.5 mmol/l.
The first physiological response of the body during hypoglycemia is the
inhibition of insulin release followed by an increase in glucagon release and
other counterregulatory hormones. Autonomic symptoms such as anxiety, pallor,
palpitations, restlessness, perspiration, tachycardia, tremor and warmth,
emerge at plasma glucose levels below 3.2 mmol/l. Neuroglycopenic symptoms such
as confusion, drowsiness, fatigue, inability to concentrate, irritability, lack
of muscular coordination, lightheadedness, paresthesia, personality change,
slurred speech and weakness follow if plasma glucose drops below 2,8 mmol/l.
These symptoms and the autonomic symptoms are reversible.
Fingerprick:Periodic fingerpricks to control for glucsose values could be
inconvenient. During first 24 hrs patients will be monitored for viatal signs
each our as in standard care. Fingerpricks will be intergrated in these moments
as much as possible.
Enteral tube feeding.
Patients can experience enteral tube feeding as incomfortable. Diarrhea and
local skin infections have been reported.
AMC H2-222
1100 DE Amsterdam
Nederland
AMC H2-222
1100 DE Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
1) Supratentorial stroke with a time of onset within 24h before presentation.
2) An acute neurological deficit measurable with the National Institute of Health Stroke Score (NIHSS, see appendix B) > 4 at presentation.
3) Venous plasma admission glucose > 7.0 mmol/l 5) Informed consent.
Exclusion criteria
1) Signs of cerebral hemorrhage on computed tomography scan.
2) Previous history of diabetes mellitus and treatment with insulin.
3) Decreased consciousness (Glasgow Coma Scale < 8).
4) Patients in whom death appears imminent.
5) Patients under the age of 18
6) Pregnant patients
7) Patients admitted from a different coverage area.
8) When another patient is already included at that time.
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-004464-40-NL |
| CCMO | NL19371.041.07 |