Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00467246
Status:
WITHDRAWN
Last Update Posted:
2007-04-30
First Post:
2007-04-27
Brief Title:
Sub-Cutaneous Insulin in Hyperglycaemic Emergencies
Sponsor:
The Royal Bournemouth Hospital
Organization:
The Royal Bournemouth Hospital
Study Overview
Official Title:
The Use of a Long-Acting Sub-Cutaneous Insulin Analogue in the Management of Hyperglycaemic Emergencies
Status:
WITHDRAWN
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Ethics approval denied
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hyperglycaemic emergencies are associated with significant mortality mortality in Diabetic Ketoacidosis 065 - 33 and in HyperOsmolar Non-Ketotic Coma 12 -17 To reduce morbidity and mortality prompt intervention and coma and close monitoring are essential The study is designed to investigate whether a simple intervention with a long acting insulin can improve resolution of acidosis and hyperglycaemia prevent recurrence of ketoacidosis and shorten hospital stay
Detailed Description:
This is a randomised trial concerning patients presenting in A E with a diabetic emergency either a Diabetic Ketoacidosis DKA or a Hyperosmolar Non-Ketotic Coma HONC Once informed consent has been given each patient will receive standard intravenous treatment They will also receive a daily sub-cutaneous bolus of either a long-acting insulin or a placebo
Blood will be taken at regular intervals to analyse the rate of fall of glucose and normalisation of blood pH
Blood will be taken at regular intervals to analyse the rate of fall of glucose and normalisation of blood pH
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