The Multicentre Prospective Observational Study on the Management of Septic Shock (Observational Study on Septic Shock, the OSS Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5,000
- 主要终点
- clinical practices for the treatment and monitoring of patients with septic shock
研究概览
简要总结
Although there are published guidelines for the management of shock in general and septic shock in particular, the extent to which these guidelines are adhered to or achievable is unknown. Our study aims to describe, in a large population of critical care patients, the management procedures for septic shock, the applicability of existing guidelines, and the characteristics of the centres.
The primary objective is to assess current clinical practices for the treatment and monitoring of patients with septic shock.
The secondary objectives are to investigate the association of current clinical practices for the treatment and monitoring with 28-day all-cause mortality, to assess the association of current clinical practices for the treatment and monitoring with other outcomes, including 90-day all-cause mortality, ICU length of stay, days without renal replacement therapy, days without vasopressors support and days without invasive mechanical ventilation, to assess the factors that influence the disparity of practices, among the severity of the patients, the country, the availability of drugs and devices and to measure the relative frequency of balanced fluid and isotonic saline administration.
详细描述
1.1. Septic shock Sepsis is currently defined as a life-threatening disease triggered by a dysregulated host response to infection. The most common sites of infection are pulmonary (40-60% of cases), abdominal (15-30%), genitourinary (15-30%), bloodstream, and skin or soft tissue, with significant geographic variation. A pathogen is identified in approximately 60-70% of cases. Multiple non-infectious inflammatory conditions, such as severe trauma, pancreatitis, severe vasculitis, or cardiac arrest associated with ischemia-reperfusion events, can present with pathophysiological abnormalities and presentations identical to those of purely infectious sepsis.
Sepsis represents a major global health problem. An estimated 49 million cases of sepsis and 11 million related deaths occur worldwide each year. The causes, incidence, and outcomes vary by geographic region and age. In addition to being a life-threatening condition, sepsis contributes to the development of other conditions, including cognitive impairment, functional impairment, and new or worsening chronic health problems.
In 2016, the Sepsis-3 group defined septic shock as "a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities are associated with a higher risk of mortality than in sepsis alone. Patients with septic shock can be clinically identified by the need for vasopressor therapy to maintain a mean arterial pressure ≥ 65 mmHg and a serum lactate level > 2 mmol/L without hypovolaemia" [1]. Septic shock thus represents the most severe form of sepsis, with in-hospital mortality being 42% compared to 25-30% for sepsis without shock [5]. Mortality from septic shock decreased by approximately 35% and 50%, respectively, from 1990 to 2017 [3].
1.2. Management of septic shock Early and effective control of the source of infection is an absolute prerequisite for improving shock. Specific haemodynamic management is based on fluid supplementation of relative and absolute hypovolaemia. In the case of resistance to this fluid resuscitation, the administration of vasopressors counteracts venous and arterial vasoplegia. Failure to achieve the therapeutic targets set with this treatment may lead to the addition of corticosteroids and a second-line vasopressor. In parallel with this treatment, organ failures are compensated.
1.3. Unknown or poorly described clinical aspects The uncertainties regarding the routine clinical management of patients with septic shock, which this study will attempt to address, mainly concern the following elements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Hospitalization in intensive care unit
- •Presence of septic shock, defined by the SEPSIS-3 criteria:
- •Suspected or documented infection
- •Acute elevation of the SOFA score ≥2 points
- •Persistent hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation
排除标准
- •Refusal to participate by the patient's relatives or the patient themselves.
- •Patient already hospitalized in the ICU at the time of inclusion. It should be noted that prior inclusion in the study does not constitute an exclusion criterion.
研究组 & 干预措施
septic shock patients
Any patients ≥18 years, hospitalization in intensive care unit with a suspected or documented infection and requiring vasopressors
结局指标
主要结局
clinical practices for the treatment and monitoring of patients with septic shock
时间窗: up to day 90
To assess current clinical practices for the treatment and monitoring, including sequence of their use, of patients with septic shock
次要结局
- association of clinical practices for the treatment with 28-day all-cause mortality(up to day 90)
- association of clinical practices for the hemodynamic monitoring with 28-day all-cause mortality(up to day 90)
- association of clinical practices for the treatment and monitoring with 90-day all-cause mortality(day 90)
- association of clinical practices for the treatment and monitoring with days without renal replacement therapy(day 90)
- association of clinical practices for the treatment and monitoring with days without vasopressor support(day 90)
- association of clinical practices for the treatment and monitoring with days without invasive mechanical ventilation(day 90)
研究者
Xavier Monnet
Professor
Bicetre Hospital