Clinical trial NCT00467636: Insulin Therapy in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Official title: Influence of Insulin Therapy in Patients Admitted to Hospital With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Hyperglycemia
Keywords: Chronic Obstructive Pulmonary Disease
Corticosteroid induced hyperglycaemia
Insulin
Lead sponsor: The Royal Bournemouth Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2007-04-30
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 1.5 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 mmol/l) 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.

Eligibility criteria: Inclusion criteria

* Patients who are NOT diabetic, admitted with COPD who are likely to be prescribed corticosteroids as part of usual care with an admission glucose level (before steroids) between 6.1 and 11.1 mmol/l.

Exclusion criteria:

* Patients with diabetes mellitus
* Patients who are nil by mouth.
* Patients with severe co-morbid disease with an anticipated life expectancy of \< 6 months.
* Patients who are unable to provide informed consent.
* Age \<18 years.

Primary outcomes:
measure: Rate of re-admission to hospital within 90 days.
timeFrame: 90 days after discharged from hospital
Secondary outcomes:
measure: Length of stay
timeFrame: oct 2009
measure: In-patient mortality
timeFrame: look at cause death. for statistical purpose oct 2009
measure: Spirometry at baseline, day 3 and prior to discharge
timeFrame: oct 2009
measure: Achieved glucose levels
timeFrame: oct 2009
measure: Hypoglycaemic events (<4 mmol/l with or without symptoms)
timeFrame: instigate hypoglycaemia protocol at time. for statistical purpose oct 2009.
measure: Frequency of positive sputum cultures
timeFrame: oct 2009
measure: Change in CRP and IL-6 levels between baseline and day 5
timeFrame: oct 2009
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: Dorset
Study officials:
affiliation: Royal Bournemouth Hospital NHS Trust
name: David Kerr, MD
role: PRINCIPAL_INVESTIGATOR
References: