Comparative Study of C-reactive Protein vs. Procalcitonin to Guide Antibiotic Therapy in Patients With Severe Sepsis and Septic Shock Admitted to the Intensive Care Unit.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Days alive without antibiotics
研究概览
简要总结
In this study the investigators aim to test if C-reactive protein (CRP)or procalcitonin(PCT) - guided strategy allows to reduce the antibiotic use in patients wiht severe sepsis and septic shock. Therefore, the safety of this intervention will be carefully measured.
详细描述
Methods
- Patients and settings: Prospective controlled randomized open interventional study of antibiotic therapy in adult with severe sepsis or septic shock, admitted to the intensive care unit.
The study will be conducted in the intensive care unit (ICU) of the University Hospital Risoleta Tolentino Neves of the Federal University of Minas Gerais, Brazil. This is a 30-bed ICU with medical and surgical patients. All patients with suspected severe sepsis or septic shock admitted to the ICU will be assessed for eligibility. Patients developing severe sepsis or septic shock during their ICU stay will be also considered for enrollment.
Cultures of urine, blood, bronchoalveolar lavage fluid, and tracheal aspirates will be performed on admission and during ICU stay as clinically indicated. Blood gases and imaging exams will also be performed as clinically indicated, similarly in both groups.
- Interventions:
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
- Single (Participant)
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 > 17 years
- •patients in intensive care unit
- •signed informed consent
- •suspected or confirmed severe sepsis or septic shock
排除标准
- •Infections caused by Listeria spp, Legionella pneumophilia, Mycobacterium tuberculosis
- •Bacteremia due S. aureus
- •Infections requiring prolonged therapies, such as endocarditis, cerebral abscess, chronic osteomyelitis
- •Suspected or confirmed infection caused by virus, parasites
- •Infections caused by P. aeruginosa ou A. baumannii
- •Severe immunosuppression (ex: AIDS, post bone-marrow transplant,cystic fibrosis)
- •Traumatism latest five days
- •Surgery latest 5 days
- •Carcinoid tumor, lung cancer, medullary thyroid cancer
结局指标
主要结局
Days alive without antibiotics
时间窗: 28 days
Total antibiotic exposure days per 1,000 days
时间窗: 28 days
Duration of antibiotic therapy for the first episode of infection
时间窗: 28 days
次要结局
- All cause 28-day mortality(28 days)
- In-hospital mortality(28 days)
- sepsis-associated death(28 days)
- clinical cure rate(28 days)
- Nosocomial infection rate(28 days)
- Nosocomial superinfection (diagnosed more than 48hous after discontinuation of the antibiotic therapy given to the first episode of infection)(28 days)
- Length of hospital stay(The whole hospitalization)
- Isolation of resistant bacteria(28 days)
- Infection relapse (diagnosed less than 48h after antibiotic discontinuation)(48 hours)
- Length of ICU stay(Whole hospitalization)
研究者
Vandack Alencar Nobre
Associate Professor, PhD
Federal University of Minas Gerais