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临床试验/NCT03617965
NCT03617965Unknown不适用

Mortality Due to Septic Shock Associated With Thrombocytopenia in the Intensive Care Unit

Universidad de Guanajuato1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2018年8月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
350
试验地点
1
主要终点
Survival and mortality rate

研究概览

简要总结

A prospective longitudinal study similar to the one performed by Claushuis and colleagues (2016) will be performed in order to further understand the epidemiology and clinical relationship between platelet levels and mortality secondary to septic shock in a different population. The primary objective is to compare the mortality due to septic shock between patients with thrombocytopenia and patients with normal platelet levels in the ICU of the General Hospital of León, Gto. The secondary objectives are to identify the association between mortality due to septic shock and mild, moderate and severe thrombocytopenia in patients admitted to the ICU at 30, 60 and 90 days.

Research questions

Is there an association between thrombocytopenia and mortality due to septic shock in patients admitted to the critical medicine service? Our hypotheses are that:

  1. Mortality from septic shock and thrombocytopenia at 30, 60 and 90 days will be higher in patients with thrombocytopenia than in patients normal platelet counts.

Is there an association between the degree of thrombocytopenia and mortality from septic shock in patients admitted to the critical medicine service? Our hypotheses are that:

  1. Mortality from septic shock and thrombocytopenia at 30, 60 and 90 days will be higher in patients with mild thrombocytopenia than in patients without thrombocytopenia.
  2. Mortality from septic shock and thrombocytopenia at 30, 60 and 90 days will be higher in patients with moderate thrombocytopenia than in patients without thrombocytopenia.
  3. Mortality from septic shock and thrombocytopenia at 30, 60 and 90 days will be higher in patients with severe thrombocytopenia than in patients without thrombocytopenia.

详细描述

Background

Sepsis has a high morbidity and mortality, hence is a challenging medical problem throughout the world. Three therapeutic principles must be taken into account to improve organ dysfunction and survival in sepsis: 1) early and adequate antimicrobial therapy; 2) reestablishment of adequate tissue perfusion; and 3) timely identification and control of the septic foci. Moreover, survival in sepsis depends on the timely identification and appropriate treatment. Progressive advances in sepsis management over the past decades have led to reduced mortality indices. Mortality rates have decline progressively from 43% in 1993 to 37% in 2003, to 29% in 2007; furthermore, reaching a low in 2012 of 18.4%. All in all, in order to establish a global outlook and adequate therapeutic algorithms for sepsis, the factors associated with high mortality rates in septic shock must be identified.

Severe sepsis and septic shock are two clinical entities that have a great impact on intra-hospital morbidity and mortality, as well as on the cost of health care systems; accounting for a large proportion among the causes of admission to the intensive care unit (ICU). In the United States in 2013, septicemia was the hospital condition that accounted for the highest cost, reaching a total cost of $23.7 billion dollars (i.e. 6.2% of total hospitalization costs); followed by osteoarthritis (i.e. $16.5 billion dollars, 4.3% of total hospitalization costs), births (i.e. $13.3 billion, 3.5%), complications arising from medical devices, implants or grafts (i.e. $12.4 billion, 3.3%), and acute myocardial infarction (i.e. $12.1 billion, 3.2%).

The prevalence of sepsis at the ICU across multiple centers in Spain ranges between 6 and 30%. Furthermore, more than 50% of patients with sepsis develop severe sepsis and 25% septic shock. Carrillo-Esper and colleagues (2009) report that in Mexican public and private institutions, 27.3% of 40,957 hospitalizations (i.e. 11,183 cases) developed sepsis. This study which included data from ICUs of 24 out of 32 federal entities reports a mortality secondary to sepsis of 30.4%. In Mexico, the hospitalization costs of patients with sepsis is also a cause of concern, with a total estimated cost of $835 million dollars and an average patient cost of $73,000 dollars.

Sepsis definition

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with sepsis (white blood cells >14,000μL) and thrombocytopenia (<150,000/μL).
  • Patients who receive care in the ICU of the General Hospital of León, Gto.
  • Patients with a complete file with 90-day evolution notes.

排除标准

  • Patients diagnosed with cardiogenic, hypovolemic, anaphylactic and neurogenic shock
  • Patients older than 80 years or younger than 18 years of age
  • Patients referred from another ICU
  • Patients with a diagnosis of neoplasia (i.e. hematologic and/or solid tumor)
  • Pregnant women
  • Patients with liver cirrhosis
  • Patients with splenectomy
  • Patients with thrombocytosis (i.e.> 400,000/μL) upon admission to ICU
  • Patients with previous use of drugs that could produce thrombocytopenia ( e.g. calcium carbonate, acetylsalicylic acid, clopidogrel, dipyridamole, tamoxifen, cisplatin, bexarotene, doxorubicin, and lovastatin.
  • Elimination Criteria:
  • Patients who do not have a follow-up at 30, 60 and 90 days.

结局指标

主要结局

Survival and mortality rate

时间窗: 30 days after ICU admission

Multivariate-adjusted Cox proportional hazards regression models will be used to study the relationship between the diagnostic groups upon admission to the ICU and the mortality rate. Cox regression models adjusted to control the influence of sociodemographic variables will be used. Kaplan-Meier graphs will be used to show differences in the risk of progression to sepsis, septic shock, and death at 30 days.

次要结局

  • Association between platelet levels and diagnosis(30 days after ICU admission)
  • Survival and mortality rate(90 days after ICU admission)
  • Platelet serum levels will be compared with the different clinical outcomes(30 days after ICU admission)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaime Daniel Mondragón Uribe

Principal Investigator

Universidad de Guanajuato

研究点 (1)

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