Effect of Corticosteroids On MyocardiaL Injury Among Patients Hospitalized for Community-AcquirEd PneUMonia - COLOSSEUM TRIAL
Overview
- Phase
- Phase 3
- Intervention
- Methylprednisolone Sodium Succinate
- Conditions
- Community-acquired Pneumonia
- Sponsor
- University of Roma La Sapienza
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- High sensitivity cardiac T troponin (myocardial injury biomarker)
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
Community-acquired pneumonia (CAP) is often complicated by elevation of cardiac troponin, a marker of myocardial injury, that can be isolated or associated to myocardial infarction (MI). A retrospective study showed that corticosteroid treatment lowers incidence of MI during the hospital-stay.
The aim of this clinical trial is to examine whether in-hospital treatment with iv methylprednisolone (20 mg b.i.d) may reduce myocardial injury, as assessed by serum high-sensitivity cardiac T Troponin) and eventually cardiovascular events during a short- and long-term follow-up in patients hospitalized CAP.
Detailed Description
Background. Community-acquired pneumonia (CAP) is often complicated by elevation of cardiac troponin, a marker of myocardial injury, that can be isolated or associated to myocardial infarction (MI). A retrospective study showed that corticosteroid treatment lowers incidence of MI during the hospital-stay. No data exist so far on the effect of corticosteroids on myocardial injury in CAP patients. Study design. Double-blind randomized placebo-controlled trial. One hundred twenty-two eligible patients will be randomized to a week treatment with iv methylprednisolone (20 mg b.i.d) or placebo from hospital admission. Serum hs-cTnT will be measured at admission and every day until up 3 days from admission. ECG will be monitored every day until discharge. After dismission, all patients will be followed-up 2 years. Aims of the study. Primary objective of the study is to evaluate if methylprednisolone is able to reduce myocardial injury, as assessed by serum high-sensitivity cardiac T Troponin (hs-cTnT), in a cohort of patients hospitalized for CAP. Secondary aims are to evaluate the potential effect of methylprednisolone on cardiovascular events during hospitalization, at 30 day from hospital admission and during 2 years' follow-up. The trial will also examine whether the potential protective effects of methylprednisolone might be due to platelet activation down-regulation.
Investigators
Francesco Violi
Prof. Francesco Violi
University of Roma La Sapienza
Eligibility Criteria
Inclusion Criteria
- •Hospitalization for community-acquired pneumonia
Exclusion Criteria
- •Use of corticosteroids in the previous 30 days
- •Health Care-Associated Pneumonia
- •Reported severe immunosuppression (human immunodeficiency virus infection, immunosuppressive conditions or medications)
- •Preexisting medical condition with a life expectancy of less than 3 months
- •Uncontrolled diabetes mellitus
- •Gastritis with or without major gastrointestinal bleeding within 3 months
- •Any condition requiring acute treatment with glucocorticoids
Arms & Interventions
Treatment group
Methylprednisolone Sodium Succinate (20mg/ml) will be given at the dose of 40 mg/day (20 mg x 2/day). The treatment will last 7 days (or the time of hospitalization if the patient is discharged in a period less or more than 7 days).
Intervention: Methylprednisolone Sodium Succinate
Placebo group
Saline Solution for Injection will be given ath the dose of 2 ml/day. The treatment placebo will last 7 days (or the time of hospitalization if the patient is discharged in a period less or more than 7 days).
Intervention: Saline Solution for Injection
Outcomes
Primary Outcomes
High sensitivity cardiac T troponin (myocardial injury biomarker)
Time Frame: 7 days
Primary endpoint of the study will be a significant reduction of hs-cTnT increase. Hs-cTnT will be measured . Hs-cTnT levels will be measured by the Elecsys 2010 (Roche Diagnostics, Indianapolis, IN) in a dedicated core laboratory.
Secondary Outcomes
- Serum TxB2 (biomarker of platelet activation)(7 days)
- sP-selectin (biomarker of platelet activation).(7 days)
- sCD40L (biomarker of platelet activation).(7 days)
- High-sensitivity C-Reactive Protein(7 days)
- Serum sNOX2-dp (biomarker of oxidative stress)(7 days)
- Serum F2-isoprostanes (biomarker of oxidative stress)(7 days)
- Urinary F2-isoprostanes (biomarker of oxidative stress)(7 days)
- Cardiovascular events during hospitalization.(7 days)
- Major adverse cardiac and cerebrovascular events (MACCE) at 30 days.(30 days)
- Major adverse cardiac and cerebrovascular events (MACCE) during a a long-term follow-up.(2 years)
- Short-term mortality(30 days)
- Long-term mortality(2 years)