Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00467636
Status:
TERMINATED
Last Update Posted:
2009-10-02
First Post:
2007-04-27
Brief Title:
Insulin Therapy in Chronic Obstructive Pulmonary Disease COPD Exacerbations
Sponsor:
The Royal Bournemouth Hospital
Organization:
The Royal Bournemouth Hospital
Study Overview
Official Title:
Influence of Insulin Therapy in Patients Admitted to Hospital With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Status:
TERMINATED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty recruiting early discharge scheme initiated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effect of preventing hyperglycaemia in patients admitted to hospital with acute exacerbations of chronic pulmonary disease
Detailed Description:
Hyperglycaemia is associated with increased morbidity and mortality in patients admitted to hospital with acute critical illness myocardial infarction and stroke Moreover patients with hyperglycaemia have a significantly longer hospital stay higher rates of ICU admission increased in-hospital mortality and are more likely to require transfer to a nursing home Recently interventional studies have linked reversal of hyperglycaemia to better clinical outcomes especially in acute myocardial infarction cardiac surgery and in critically ill patients
In England and Wales it is estimated that the number of people with COPD is approaching 15 million The morbidity and economic costs associated with the condition are extremely high with approximately 10 of all acute medical admissions caused by exacerbations of the underlying condition As a corollary about 15 of patients with COPD need admission to hospital each year
Acute hyperglycaemia is common among patients admitted with acute exacerbations of COPD The reasons for this are likely to be multi-factorial including an association between COPD and increased risk of developing diabetes at least in women the elderly nature of the two populations and the use of glucocorticoids which markedly increases the risk of hyperglycaemia Admission hyperglycaemia 11 mmoll also appears to predict increased morbidity for patients with COPD admitted to intensive care
The trial will be a randomised trial of comparison of usual treatment vs intensive insulin treatment for patients with COPD who may or may not have diabetes Patients will take part in the trial for the first 5 days during their hospital stay
In England and Wales it is estimated that the number of people with COPD is approaching 15 million The morbidity and economic costs associated with the condition are extremely high with approximately 10 of all acute medical admissions caused by exacerbations of the underlying condition As a corollary about 15 of patients with COPD need admission to hospital each year
Acute hyperglycaemia is common among patients admitted with acute exacerbations of COPD The reasons for this are likely to be multi-factorial including an association between COPD and increased risk of developing diabetes at least in women the elderly nature of the two populations and the use of glucocorticoids which markedly increases the risk of hyperglycaemia Admission hyperglycaemia 11 mmoll also appears to predict increased morbidity for patients with COPD admitted to intensive care
The trial will be a randomised trial of comparison of usual treatment vs intensive insulin treatment for patients with COPD who may or may not have diabetes Patients will take part in the trial for the first 5 days during their hospital stay
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