Statins for the Early Treatment of Sepsis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Time to Clinical Stability
研究概览
简要总结
We propose a Phase II, randomized, placebo-controlled clinical trial to test the hypothesis that treatment with once-daily statins has a beneficial effect on inflammatory cytokines and clinical outcomes in adults hospitalized with sepsis. As our animal models suggest pretreatment with statins are required for their beneficial effects, we propose a study design intended to identify patients and initiate treatment early in their hospital stay. This Phase II study is intended to assess the feasibility of conducting a large-scale investigator-initiated translational research protocol that involves multiple clinical services within the Department of Medicine.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Initial presentation to the Emergency Department or University of Chicago MD office/Dialysis Center for current hospital admission
- •Sepsis (ACCP/SCCM criteria)
- •Clinically suspected infection as per the treating physician or confirmed infection
- •2 or more of the following: Temperature 38ºC (100.4ºF)or 36ºC (96.8ºF), Heart rate (HR) > 90/min, Respiratory rate (RR) > 20/min or PaCO2 < 32 mmHg, White blood cell count > 12,000/mm3 or < 4000/m3 or > 10%immature neutrophils
- •Initiation of antibiotics by treating physician for sepsis
- •Hospitalized from the Emergency Department or University of Chicago MD office/Dialysis Center to an inpatient medical service (intensive care unit (ICU)or non-ICU service) OR admission to the medical ICU (MICU) from a non-ICU inpatient medical floor.
- •Assent of the primary treating physician at the time of enrollment.
- •The meeting of SIRS criteria is due to an infection as per the treating physician.
排除标准
- •Pregnancy
- •ALT >3 times above the upper limit of normal
- •Elevated creatine phosphokinase (CPK) (>3 times the upper limit of normal)
- •Concurrent treatment with any of the following drugs: daptomycin, fenofibrate, ketoconazole,triaconazole, amiodarone, clarithromycin, cyclosporine, erythromycin,nefazodone, niacin, protease inhibitors, telithromycin, verapamil,danazol, gemfibrozil
- •History of allergy or intolerance to statins
- •Greater than 16 hours after meeting inclusion criteria
- •Use of 1 more doses of statins in the previous 4 weeks
- •Clinical indication for treatment with statin during hospital admission (per treating physician)
- •Sufficiently poor prognosis prior to enrollment that treating physicians have elected to employ comfort care or plan to discharge to hospice
- •Transfer from surgical service to medical service
- •Needing transfusion for either active bleeding or severe hemolysis.
研究组 & 干预措施
1
Simvastatin 80 mg once daily PO (or via NG or G-tube)
干预措施: Simvastatin (Drug)
2
Identical-appearing placebo PO (or via NG or G-tube)
干预措施: Identical-appearing placebo (Drug)
结局指标
主要结局
Time to Clinical Stability
时间窗: 24 hours
Normalization of vital signs for each subject enrolled. This is expressed as a mean time to normalization for each +/- standard error.
次要结局
未报告次要终点