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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04698382
• Other study ID #: BD022384
• Status: Withdrawn
• Start date: August 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Sepsis
• Septic Shock
• Shock, Septic
• Toxemia

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of hospital and ICU Admission	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	From admission to in-hospital death or discharge to hospice
Primary	In-hospital Mortality	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	From admission to in-hospital death or discharge to hospice
Secondary	Sepsis management quality metrics	Determine the impact of COVID-19 on quality metrics in the management of sepsis patients	From time of admission to death during the hospitalization