Hyperglycemias Clinical Trial
Official title:
Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia
The aim of this study is to test the safety and efficacy of a new algorithm for intensive s.c. insulin injection in medical emergency patients with hyperglycaemia (plasma glucose concentration ≥ 8 mmol/l)
BACKGROUND: Prospective randomized trials have shown that near-normoglycemic blood glucose
control using insulin infusions achieves a significant reduction in mortality of severely
ill patients in intensive care units, of patients with acute myocardial infarction and with
stroke. This implies that most severely ill patients with hyperglycemia should be treated
with insulin to reach near-normoglycemia. However, this is not common practice today in
emergency room admissions outside the intensive care unit, and strategies to achieve
near-normoglycemia safely outside the ICU setting with s.c. injections (insulin infusions
are too risky outside the ICU) have not been established.
AIM: To evaluate an insulin therapy algorithm using s.c. injections which permits effective
and safe glycemic management of emergency room patients with hyperglycemia.
DESIGN: Randomized, controlled trial with an open intervention. Patients presenting with
hyperglycemia on admission to the emergency room are randomized 1:1 either to conventional
treatment (conventional insulin group) or to intensive treatment (intensive insulin group).
METHODS: 140 patients admitted to the medical emergency rooms of the University Hospital
Basel and the Regional Hospital of Solothurn will be included and randomized as described
above. All patients with plasma glucose levels exceeding 8.0 mmol/l will be included.
Exclusion criteria include severely immunocompromised patients, patients in shock, patients
with terminal illnesses on palliative care, type 1 diabetes with or without ketoacidosis and
patients which require intensive care unit (ICU) or cardial care unit (CCU) therapy.
PRIMARY ENDPOINT: Time in the glycaemic target range (5.5-7.0 mmol/l) during the period of
observation of 48 hours (expected to be longer in the intensive insulin group)
SECONDARY ENDPOINTS: Time to reach the target range. Frequency of hypoglycaemia (plasma
glucose < 3.8 mmol/l). Frequency of severe hypoglycaemia (plasma glucose < 2.5 mmol/l.
Frequency of hypokalaemia.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment