Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353431
Status:
COMPLETED
Last Update Posted:
2012-05-18
First Post:
2006-07-17
Brief Title:
Evaluation of an Algorithm for Intensive sc Insulin Therapy in Emergency Room Patients With Hyperglycaemia
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Evaluation of an Algorithm for Intensive sc Insulin Therapy in Emergency Room Patients With Hyperglycaemia
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to test the safety and efficacy of a new algorithm for intensive sc insulin injection in medical emergency patients with hyperglycaemia plasma glucose concentration 8 mmoll
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 sc injections insulin infusions are too risky outside the ICU have not been established
AIM To evaluate an insulin therapy algorithm using sc 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 11 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 80 mmoll 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 55-70 mmoll 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 38 mmoll Frequency of severe hypoglycaemia plasma glucose 25 mmoll Frequency of hypokalaemia
AIM To evaluate an insulin therapy algorithm using sc 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 11 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 80 mmoll 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 55-70 mmoll 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 38 mmoll Frequency of severe hypoglycaemia plasma glucose 25 mmoll Frequency of hypokalaemia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN55224894 | REGISTRY | Current Controlled Trials Database | None |