Effect of Corticosteroids On MyocardiaL Injury Among Patients Hospitalized for Community-AcquirEd PneUMonia - COLOSSEUM TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- High sensitivity cardiac T troponin (myocardial injury biomarker)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Doctors, staff and any primary care provider/s involved in the participant's non-trial management will be blinded to the group allocations. Individual participants will be not told their group allocation until the end of their involvement in the trial and after the completion of the trial
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalization for community-acquired pneumonia
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Methylprednisolone Sodium Succinate (Drug)
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).
干预措施: Saline Solution for Injection (Drug)
结局指标
主要结局
High sensitivity cardiac T troponin (myocardial injury biomarker)
时间窗: 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.
次要结局
- 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)
研究者
Francesco Violi
Prof. Francesco Violi
University of Roma La Sapienza