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The goal of this cluster randomized controlled trial is to determine the optimal treatment for Acute Exacerbation of Chronic Obstructive Pulmonary Disease. The study compares the effects and side effects of hydrocortisone and prednisolone in patients above 40 years old diagnosed with chronic obstructive pulmonary disease with acute exacerbation. The main question is whether there is a difference in readmission for COPD excerbation or all cause mortality within thirty days.
Participants will randomized to receive treatment with either hydrocortisone or prednisolone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Hydrocortisone. | Active Comparator | This arm will recieve a dose of 200 mg of Hydrocortisone intravenously once daily for five days. |
|
| Treatment with Methylprednisolone | Active Comparator | This arm will recieve a dose of 40 mg of Methylprednisolone intravenously once daily for five days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone (drug) | Drug | ATC code: H02AB06. Can be changed to Prednisolone 50 mg orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Readmission for COPD exacerbation or death from all causes | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Days alive and out of hospital | 14 days | |
| Mortality | 90 days | |
| Readmission for COPD exacerbation |
| Measure | Description | Time Frame |
|---|---|---|
| Procalcitonin (PCT) at baseline | Procalcitonin (PCT) at baseline, day 3 and day 7. If still at hospital. | 7 days |
| C-reactive protein (CRP) at baseline | C-reactive protein (CRP) at baseline, day 3 and day 7. If still in hospital. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jens-Ulrik Stæhr Jensen, MD, PHD | Contact | 38673057 | +45 | jens.ulrik.jensen@regionh.dk |
| Pradeesh Sivapalan, MD, PHD | Contact | 29880601 | +45 | pradeesh.sivapalan.02@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Jens-Ulrik Stæhr Jensen, MD, PHD | COP:RESP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bornholm Hospital | Recruiting | Rønne | Bornholm | 3700 | Denmark | |
| Amager Hospital |
This has not yet been decided.
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The study is a cluster randomized controlled trial. It consists of two arms, in which patients will be randomized to receive treatment with either Hydrocortisone or Methylprednisolone.
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| Hydrocortisone | Drug | ATC-code: H02AB09. Can be changed to 50 mg x 4 daily orally if appropriate. |
|
| 90 days |
| All-cause infections | Defined as a new prescription of antibacterial medication. | 90 days |
| Need for mechanical ventilation | 30 days |
| New onset infections | 30 days |
| Daily amount of insulin administered to the patient by day 7 or discharge from hospital | 7 days |
| Gastrointestinal bleeding | 30 days |
| Blood glucose levels | Measured at day 3 and day 7 | 7 days |
| 7 days |
| Blood eosinophil count (EOS) at baseline | Blood eosinophil count (EOS) at baseline, day 3 and day 7. If still in hospital. | 7 days |
| Recruiting |
| Copenhagen |
| Copenhagen City |
| 2300 |
| Denmark |
| Bispebjerg Hospital | Recruiting | Copenhagen | Copenhagen City | 2400 | Denmark |
| Frederiksberg Hospital | Recruiting | Frederiksberg | Copenhagen City | 2000 | Denmark |
| Gentofte Hospital | Recruiting | Hellerup | Copenhagen City | 2900 | Denmark |
| Herlev Hospital | Recruiting | Herlev | Copnhagen Surroundings | 2730 | Denmark |
| Hvidovre Hospital | Recruiting | Hvidovre | Copnhagen Surroundings | 2650 | Denmark |
| Nordsjællands Hospital | Recruiting | Hillerød | North Zealand | 3400 | Denmark |
| Holbæk Sygehus | Recruiting | Holbæk | Region Sjælland | 4300 | Denmark |
| University Hospital of Region Zealand, Køge | Recruiting | Køge | Region Sjælland | 4600 | Denmark |
| Næstved Sygehus | Recruiting | Næstved | Region Sjælland | 4700 | Denmark |
| Ringsted Sygehus | Recruiting | Ringsted | Region Sjælland | 4100 | Denmark |
| University Hospital of Region Zealand, Roskilde | Recruiting | Roskilde | Region Sjælland | 4000 | Denmark |
| Slagelse Sygehus | Recruiting | Slagelse | Region Sjælland | 4200 | Denmark |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D004364 | Pharmaceutical Preparations |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
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