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

NCT04698382 | Withdrawn

• 1 other identifier: BD022384
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Septic Shock

Keywords

sepsis; septic shock; COVID-19

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Sepsis management quality metrics

  From time of admission to death during the hospitalization

Study Arms (2)

Non-COVID-19-related sepsis

Non-COVID-19 sepsis patients will be identified with sepsis or septic shock without a COVID-19 diagnosis code or a positive COVID-19 laboratory test. Sepsis patients will be defined as patients with concurrent infection and organ dysfunction. Presumed concurrent infection will be defined as a blood culture order and ≥ 3 days of antibiotics administration, including at least 24h of intravenous antibiotics, or death while on antibiotics within 3 days of admission. Organ dysfunction will be defined by ICD-10-modified acute organ failure score. Sensitivity analyses will use ICD-10 explicit sepsis codes to define non-COVID-19 sepsis instead. COVID-19 will be identified based on receiving a diagnosis code for COVID-19 (U07.1) or legacy coding (prior to the implementation of a specific COVID-19 code) present-on-admission and/or a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR) test on admission

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. These include 1. Acute Gastrointestinal Bleeding (GIB): Patients with at least one GIB ICD-10 code and one relevant CPT intervention codes. 2. Myocardial Infarction (MI): Patients with at least one MI ICD-10 code and one relevant CPT intervention codes

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• Emory University: collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic; COVID-19

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sameer S Kadri, MD, MS

  National Institutes of Health, Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Clinician, Critical Care Medicine Department

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 6, 2021
• Study Start: August 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)