Clinical trial NCT04698382: Impact of COVID-19 on the Incidence, Characteristics, Management and Outcome of Sepsis
Official title: Impact of COVID-19 on the Incidence, Characteristics, Management and Outcome of Sepsis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sepsis
Septic Shock
Keywords: sepsis
septic shock
COVID-19
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: Emory University
First posted: 2021-01-06
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-COVID-19-related sepsis This will be defined as patients identified with sepsis or septic shock without a diagnosis code of COVID-19 or a positive COVID-19 laboratory test.

Non-COVID-19, Non-Sepsis Control Population This will be defined as patients identified with emergency conditions of interest without a diagnosis code of sepsis, COVID19 or a positive COVID-19 laboratory test.

Brief summary: 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.

Detailed description: 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.

Aim 4: Determine the impact of COVID-19 on processes of care in the management of sepsis: This aim will investigate whether COVID-19 has impacted key quality processes in the management of patients with sepsis present on admission (POA).

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prevalence of hospital and ICU Admission
timeFrame: From admission to in-hospital death or discharge to hospice
measure: In-hospital Mortality
timeFrame: From admission to in-hospital death or discharge to hospice
Secondary outcomes:
measure: Sepsis management quality metrics
timeFrame: From time of admission to death during the hospitalization
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institutes of Health, Clinical
name: Sameer S Kadri, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: