Clinical trial NCT00353431: Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia
Official title: Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemias
Keywords: Hyperglycaemia
algorithm
emergency
s.c. insulin therapy
Emergency patient
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2006-07-18
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* all patients with hyperglycaemia (≥ 8.0 mmol/l) admitted to the medical emergency room.
* patients with presumed hospitalisation in ER or medical ward of more than 48 h duration.

Exclusion Criteria:

* patients in shock (defined as hypotension or shock index \> 1 with oliguria, changed mental status and metabolic acidosis)
* patients with a terminal illness on palliative care
* patients with type 1 diabetes
* patients with insulin pump therapy
* patients with need for hospitalisation in the intensive or coronary care unit.
* patients with presumed hospitalisation shorter than 48 hours
* known pregnancy (in women with childbearing potential pregnancy test for exclusion mandatory)
* no informed consent

Primary outcomes:
measure: Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours
timeFrame: 48 h
Secondary outcomes:
measure: Time to Reach the Target Range
timeFrame: 24 h
measure: Frequency of Hypoglycemia
timeFrame: during observation of 48 hours
measure: Frequency of Severe Hypoglycaemia
timeFrame: during observation of 48 hours
measure: Frequency of Hypokalaemia
timeFrame: during observation of 48 hours
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Division of Endocrinology, Diabetes & Clinical Nutrition, Dept of Internal Medicine,
state: Baselstadt
Study officials:
affiliation: Division of Endocrinology, Diabetes & Clinical Nutrition, Dept of Internal Medicine
name: Ulrich Keller, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: