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

March 21, 2024 updated by: Sameer Kadri, M.D., National Institutes of Health Clinical Center (CC)
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.

Study Overview

Status

Withdrawn

Conditions

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).

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of hospital and ICU Admission
Time Frame: 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
From admission to in-hospital death or discharge to hospice
In-hospital Mortality
Time Frame: 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
From admission to in-hospital death or discharge to hospice

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sepsis management quality metrics
Time Frame: From time of admission to death during the hospitalization
Determine the impact of COVID-19 on quality metrics in the management of sepsis patients
From time of admission to death during the hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Collaborators

Emory University

Investigators

  • Principal Investigator: Sameer S Kadri, MD, MS, National Institutes of Health, Clinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BD022384

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

N/A this data is deidentifed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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