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临床试验/NCT04698382
NCT04698382撤回不适用

Impact of COVID-19 on the Incidence, Characteristics, Management and Outcome of Sepsis

National Institutes of Health Clinical Center (CC)1 个研究点 分布在 1 个国家开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Prevalence of hospital and ICU Admission

研究概览

简要总结

This study seeks to determine the the impact of COVID-19 on the incidence, characteristics, management and outcome of patients admitted to U.S. hospitals with non-COVID-19 related sepsis.

详细描述

Sepsis is the most common cause of death and the most expensive condition among hospitalized patients in the U.S. The delivery of high-quality care for sepsis necessitates optimal institutional functionality and availability of adequate healthcare personnel and resources. However, since the novel coronavirus disease 2019 (COVID-19) pandemic hit the U.S., fear of acquisition of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in fewer patients with acute conditions seeking hospitalization. Furthermore, the rapid onslaught of COVID-19 admissions has profoundly strained hospital supplies, personnel and care processes and left little time to re-calibrate the management of other acute conditions that share these resources. As such, the impact on the detection, triage, monitoring, resuscitation, and outcome of patients with sepsis is currently unknown. Large administrative and clinical data repositories of inpatient discharges that are populated in near-real time may enable study of contemporaneous inpatients with COVID-19 and sepsis (without COVID-19) respectively.

We aim to:

Aim 1: Determine the impact of the COVID-19 pandemic on the incidence of hospital admission for non-COVID-19-related sepsis and septic shock and the proportion of these patients that receive Intensive Care Unit-level care. This analysis will assess for dynamic changes in the number of patients developing and/or seeking hospital care for sepsis and septic shock during the pandemic and whether the burden of critically ill and mechanically ventilated patients with COVID-19 may have impacted the threshold for providing ICU-level care to patients with sepsis and septic shock

Aim 2: Determine the trend in risk-adjusted mortality among patients admitted with non-COVID-19-related sepsis and septic shock during the pandemic. This analysis will indicate whether being hospitalized for sepsis/septic shock during vs. prior to the pandemic was associated with any change survival. An analysis will be performed to identify prognostic factors associated with non-COVID-19-related sepsis and septic shock.

Aim 3: Determine the impact of COVID-19-specific center-level characteristics (e.g. case volume, multi-ICU status, intubation threshold) on risk-adjusted mortality of non-COVID-19-related sepsis and septic shock during the pandemic period. Identification and modification of pandemic-related triage and processes that impact survival in sepsis may help preserve quality of care when health systems are strained.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients admitted to U.S hospitals with sepsis (without COVID-19)
  • Patients admitted to U.S hospitals with acute gastrointestinal bleeding (without COVID-19 or sepsis)
  • Patients admitted to U.S hospitals with sepsis myocardial infarction (without COVID-19 or sepsis)

排除标准

  • Patients admitted to U.S. hospitals with COVID-19
  • Patients with acute gastrointestinal bleeding with sepsis or COVID-19
  • Patients with myocardial infarction with sepsis or COVID-19

结局指标

主要结局

Prevalence of hospital and ICU Admission

时间窗: From admission to in-hospital death or discharge to hospice

Determine the impact of the COVID-19 pandemic on the incidence of hospital admission for non-COVID-19-related sepsis and septic shock and the proportion of these patients that receive Intensive Care Unit-level care

In-hospital Mortality

时间窗: From admission to in-hospital death or discharge to hospice

Determine the trend in risk-adjusted in-hospital mortality (or discharge to hospice) among patients admitted with non-COVID-19-related sepsis and septic shock

次要结局

  • Sepsis management quality metrics(From time of admission to death during the hospitalization)

研究者

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

Sameer Kadri, M.D.

Staff Clinician, Critical Care Medicine Department

National Institutes of Health Clinical Center (CC)

研究点 (1)

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