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| Name | Class |
|---|---|
| Scandinavian Critical Care Trials Group | OTHER |
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
| Centre for Research in Intensive Care (CRIC) | OTHER |
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Thromboembolisms (TEs) in patients with critical COVID-19 has been reported to be three times higher than for other critically ill patients. Immunothrombosis has been proposed as a plausible mechanism for COVID-19 coagulopathy. Corticosteroids improve survival in patients with critical COVID-19, and likely even more so with a higher dose. However, the evidence regarding the impact on the incidence of thromboembolic and bleeding events are currently uncharted. The aim of this study is to investigate if there is a difference in the incidence of thromboembolic events during ICU stay in patients with critical COVID-19 when treated with 12 mg dexamethasone compared to 6 mg dexamethasone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone 12 mg | Experimental | Intravenous bolus injection of dexamethasone 12 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 12 mg at sites, where dexamethasone is not available. |
|
| Dexamethasone 6 mg | Active Comparator | Intravenous bolus injection of dexamethasone 6 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 6 mg at sites, where dexamethasone is not available. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | ATC code H02AB02 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients discharged alive from the ICU without thromboembolic events | Number of patients discharged alive from the ICU without thromboembolic events defined as pulmonary embolism, deep venous thrombosis, ischemic stroke, myocardial infarction, transient ischemic attack, other thromboembolic events | During ICU-stay |
| Measure | Description | Time Frame |
|---|---|---|
| The cumulative proportion of thromboembolic events | The incidence of thromboembolic events defined as pulmonary embolism, deep venous thrombosis, ischemic stroke, myocardial infarction, transient ischemic attack, other thromboembolic events | During ICU-stay |
| The cumulative proportion of bleeding events |
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All patients were recruited from the CS2-trial with following inclusion/exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
For the inclusion in this post-hoc analyses there is additional criteria:
Inclusion Criteria:
- randomised in the ICU
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecka Rubenson Wahlin, MD. PhD | Karolinska Institutet Södersjukhuset | Study Director |
| Maria Cronhjort, MD PhD | Karolinska Institutet Södersjukhuset | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södersjukhuset | Stockholm | Stockholm County | 11883 | Sweden |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D016769 | Embolism and Thrombosis |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Aarhus University Hospital |
| OTHER |
| Aalborg University Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
| Linkoeping University | OTHER_GOV |
| Stockholm South General Hospital | OTHER |
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The cumulative proportion of bleeding events defined as any type of bleeding |
| During ICU-stay |
| The cumulative proportion of major bleeding events | The cumulative proportion of major bleeding event (defined as bleeding requiring transfusion of at least 2 units of Red Blood Cells (RBC) and/or intracranial bleeding and/or bleeding resulting in need for major therapeutic intervention | During ICU-stay |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |