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

NCT ID: NCT04698382

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2023-12-31

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).

Conditions

Sepsis; Septic Shock

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Responsible Party

Sameer Kadri, M.D.

Staff Clinician, Critical Care Medicine Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameer S Kadri, MD, MS

Role: PRINCIPAL_INVESTIGATOR

National Institutes of Health, Clinical

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

BD022384

Identifier Type: -

Identifier Source: org_study_id