Insulin Therapy in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

Not Applicable

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease; Hyperglycemia
• Interventions: Procedure: Blood glucose monitoring; Drug: Insulin Glulisine

• Registration Number: NCT00467636
• Lead Sponsor: The Royal Bournemouth Hospital

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.

Study Timeline

• Study First Submitted: 2007-04-27
• Study First Submitted QC: 2007-04-27
• Study First Posted: 2007-04-30
• Study Start: 2007-07
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-01
• Last Update Posted: 2009-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Blood glucose monitoring	Blood glucose monitoring for comparison with treatment arm (1)
Insulin Glulisine	Insulin Glulisine	Blood glucose monitoring and treatment of hyperglycaemia with insulin. Insulin to be with-held if pre meal blood glucose \< 4 mmol/l.

Primary Outcome Measures

Name	Time	Method
Rate of re-admission to hospital within 90 days.	90 days after discharged from hospital

Secondary Outcome Measures

Name	Time	Method
Length of stay	oct 2009
In-patient mortality	look at cause death. for statistical purpose oct 2009
Spirometry at baseline, day 3 and prior to discharge	oct 2009
Achieved glucose levels	oct 2009
Hypoglycaemic events (<4 mmol/l with or without symptoms)	instigate hypoglycaemia protocol at time. for statistical purpose oct 2009.
Frequency of positive sputum cultures	oct 2009
Change in CRP and IL-6 levels between baseline and day 5	oct 2009

Trial Locations

Locations (1)

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, Dorset, United Kingdom