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Sponsored by: |
University Hospital, Basel, Switzerland |
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Information provided by: | University Hospital, Basel, Switzerland |
ClinicalTrials.gov Identifier: | NCT00353431 |
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)
Condition | Intervention |
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Hyperglycemias |
Drug: Novorapid ®, Novo Nordisk, Denmark |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia |
Estimated Enrollment: | 140 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Conventionel
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Drug: Novorapid ®, Novo Nordisk, Denmark
Comparison of a sliding scale with an intensive s.c. scale
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2: Active Comparator
Intensive
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Drug: Novorapid ®, Novo Nordisk, Denmark
Comparison of a sliding scale with an intensive s.c. scale
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ulrich Keller, MD, Prof | 004161265252 | ukeller@uhbs.ch |
Contact: Robert Thomann, MD |
Switzerland, Baselstadt | |
Division of Endocrinology, Diabetes & Clinical Nutrition, Dept of Internal Medicine, | Recruiting |
Basel, Baselstadt, Switzerland, 4031 | |
Principal Investigator: Ulrich Keller, MD, Prof | |
Principal Investigator: Robert Thomann, MD |
Principal Investigator: | Ulrich Keller, MD, Prof | Division of Endocrinology, Diabetes & Clinical Nutrition, Dept of Internal Medicine |
Responsible Party: | Division of Endocrinology, Diabetology and Clinical Nutrition ( Prof. Dr. med. Ulrich Keller, MD ) |
Study ID Numbers: | EKBB13/06, ISRCTN55224894 |
Study First Received: | July 17, 2006 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00353431 |
Health Authority: | Switzerland: Swissmedic |
Hyperglycaemia algorithm emergency s.c. insulin therapy Emergency patient |
Metabolic Diseases Hyperglycemia Insulin, Asp(B28)- Emergencies |
Metabolic disorder Glucose Metabolism Disorders Insulin |
Disease Attributes Hypoglycemic Agents Pathologic Processes Physiological Effects of Drugs Pharmacologic Actions |