SepsisNCT04698382
Impact of COVID-19 on the Incidence, Characteristics, Management and Outcome of Sepsis
An observational study of Sepsis and Septic Shock, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis, Septic Shock
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read the 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
- Keywords
- sepsis, septic shock, COVID-19
- Medical subject headings
- Sepsis, Shock, Septic, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From admission to in-hospital death or discharge to hospice
Secondary outcomes (1)
Sepsis management quality metrics
Determine the impact of COVID-19 on quality metrics in the management of sepsis patients
Measured: From time of admission to death during the hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Aug 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Why it stopped: Reduced relevance due to end of pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Emory University
- Responsible party
- Principal investigator, Sameer Kadri, M.D., National Institutes of Health Clinical Center (CC)
- Investigators
- Sameer S Kadri, MD, MS, Principal investigator, National Institutes of Health, Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698382
- Sponsor's protocol ID
- BD022384
- Status last verified
- Mar 2024
- First submitted
- 5 Jan 2021
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: N/A this data is deidentifed
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 on the Incidence, Characteristics, Management and Outcome of Sepsis
- ClinicalTrials.gov ID
- NCT04698382
- Acronym / sponsor ID
- BD022384
- Conditions
- Sepsis, Septic Shock
- Keywords
- sepsis, septic shock, COVID-19
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Reduced relevance due to end of pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- Emory University
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
1 secondary outcome
Sepsis management quality metrics
Time frame: From time of admission to death during the hospitalization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No. N/A this data is deidentifed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameer S Kadri, MD, MS principal investigator
National Institutes of Health, Clinical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hospital and ICU Admission (time frame: From admission to in-hospital death or discharge to hospice). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.