SepsisNCT04945889

Sepsis in Geriatric Patients With Suspected Infection.

An observational study of Sepsis, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Sepsis is a complex clinical syndrome that has been defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. It is more frequent and severe in older subjects, at least in part because of delayed diagnosis and treatment due to low clinical suspicion and atypical… Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Sepsis
What is being tested?: Quick Sequential Organ Failure Assessment (qSOFA), Modified Early Warning Score (MEWS) and National Early Warning Score (NEWS)
Type of treatment: Injection or infusion
How many people: 580 participants
Where: 1 siteItaly
Study dates: 1 Apr 2019to 31 Oct 2019
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 65 years and older
All sexes
No healthy volunteers
Older adult

Study population: Older patients admitted for any cause, to an acute geriatric ward of a large university teaching hospital in North-western Italy, with at least one NICE risk factor for sepsis, providing written informed consent. Intervention (diagnostic test administration) was performed only in patients with a suspected infection, defined as the prescription of an oral and/or parenteral antibiotic therapy within a timeframe spanning from 24 hours before and 72 hours after the collection of a biological sample to perform a culture test.

Who may be able to join

Hospitalization in the Acute Geriatric Unit
Presence of at least one National Institute for Health and Care Excellence (NICE) guidance risk factor for sepsis (i.e. age ≥75 years, impaired immune function - diabetes mellitus, previous splenectomy, hematologic diseases - long-term corticosteroid therapy, immunosuppressive or antineoplastic drug treatment, surgery or other invasive procedures in the previous 6 weeks, any breach of skin integrity - e.g. pressure ulcers - intravenous drug misuse, indwelling lines or catheters)

Who cannot join

Refusal to give written informed consent

Trial locations and contacts

1 site in 1 country.

Italy1 site

S.C. Geriatria U, A.O.U. Città della Salute e della Scienza di Torino
Turin, 10128

Other trials in Italy

About this study

Official title: La Sepsi Nel Paziente Anziano: Studio Prospettico Sui Pazienti Ricoverati in Ambiente Internistico.

The Sepsis-III consensus proposed the easy to use bedside clinical score quick Sequential Organ Failure Assessment (qSOFA) to identify patients at risk for sepsis and death outside intensive care units. However, some Authors have disputed this recommendation, proposting the use of other more complex bedside tools such as the National and Modified Early Warning Scores (NEWS and MEWS, respectively) for the same purpose.

Published studies on these scores included generally younger, selected subjects, not fully representative of the population at risk for sepsis.

In the present study we aimed to evaluate the incidence of sepsis in older subjects with suspected infection in a geriatric acute ward setting, to determine and compare the accuracies of qSOFA, NEWS and MEWS to identify sepsis and to investigate factors associated with in-hospital mortality.

Conditions: Sepsis
Being tested: Quick Sequential Organ Failure Assessment (qSOFA), Modified Early Warning Score (MEWS), National Early Warning Score (NEWS)
Keywords: Sepsis, Diagnostic accuracy, Geriatric patients, Older adults, Early Warning Score, qSOFA
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quick Sequential Organ Failure Assessment (qSOFA)Diagnostic test
Also called Quick Sepsis-Related Organ Failure Assessment
Clinical bedside tool that evaluates three vital parameters, scoring one point each if altered: respiratory rate (RR) ≥22 breaths/minute, systolic blood pressure (SBP) ≤100 mmHg and altered mental status (defined in our study as either Glasgow Coma Scale (GCS) score <15 or any worsening in the Italian Oriented, Disoriented, Agitated, Sleepy scale). A qSOFA score ≥2 points is considered indicative of sepsis.
Modified Early Warning Score (MEWS)Diagnostic test
Clinical bedside tool that evaluates five vital parameters, with multiple scoring according to alteration: respiratory rate (0-3 points), heart rate (0-3 points), systolic blood pressure (0-3 points), body temperature (0-2 points), mental status (0-3 points, evaluated using the Alert, Verbal, Pain, Unresponsive - AVPU scale). A MEWS score ≥5 points is considered indicative of an acute condition at risk of sudden clinical deterioration.
National Early Warning Score (NEWS)Diagnostic test
Clinical bedside tool that evaluates seven parameters, with multiple scoring according to alteration: respiratory rate (0-3 points), oxygen saturation (0-3 points), need for any supplemental oxygen (0-2 points), body temperature (0-3 points), heart rate (0-3 points), systolic blood pressure (0-3 points), mental status (0-3 points, evaluated using the Alert, Verbal, Pain, Unresponsive - AVPU scale). A NEWS score ≥7 points is considered indicative of an acute condition at risk of sudden clinical deterioration.

Study groups in NCT04945889
Study group	Role	What they receive
Geriatric inpatients at risk for sepsis		Consecutive patients admitted to an Acute Geriatric Unit for any reason presenting at least one National Institute for Health and Care Excellence (NICE) risk factor for sepsis (age ≥75 years, impaired immune function, long-term corticosteroid therapy, immunosuppressive or antineoplastic drug treatment, surgery or other invasive procedures within 6 weeks, any breach of skin integrity, intravenous drug misuse, indwelling lines or catheters). In those with suspected infection (i.e. antibiotic prescription and a culture test within 24 hours before-72 hours after), clinical parameters (respiratory rate, blood pressure, heart rate, body temperature, peripheral oxygen saturation, mental status) were assessed at least twice daily throughout hospital stay and used by study investigators to determine the qSOFA, NEWS and MEWS. Receives: Diagnostic Test: Quick Sequential Organ Failure Assessment (qSOFA); Diagnostic Test: Modified Early Warning Score (MEWS); Diagnostic Test: National Early Warning Score (NEWS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Sepsis diagnosis at discharge
Presence in discharge documents of International Classification of Diseases 9th revision, Clinical Modification (ICD-9-CM) codes at discharge of either severe sepsis (995.92) or septic shock (785.52) or as the simultaneous presence in discharge documents of ICD-9-CM codes of infection and at least one acute organ dysfunction (Angus method).
Measured: 10 days from enrollment in mean (discharge from hospital)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201931 Oct 2019

First posted30 Jun 2021
Study start1 Apr 2019
Primary completion31 Oct 2019
Study completion31 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
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: Other
Time perspective: Prospective
Enrolment: 580 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04945889
Sponsor's protocol ID: 0069708/2019
Status last verified: Jun 2021
First submitted: 28 Jun 2021
Last updated: 30 Jun 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338
Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
PubMed 11445675
Rowe TA, McKoy JM. Sepsis in Older Adults. Infect Dis Clin North Am. 2017 Dec;31(4):731-742. doi: 10.1016/j.idc.2017.07.010.
PubMed 29079157
Seymour CW, Liu VX, Iwashyna TJ, Brunkhorst FM, Rea TD, Scherag A, Rubenfeld G, Kahn JM, Shankar-Hari M, Singer M, Deutschman CS, Escobar GJ, Angus DC. Assessment of Clinical Criteria for Sepsis: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):762-74. doi: 10.1001/jama.2016.0288.
PubMed 26903335
Song JU, Sin CK, Park HK, Shim SR, Lee J. Performance of the quick Sequential (sepsis-related) Organ Failure Assessment score as a prognostic tool in infected patients outside the intensive care unit: a systematic review and meta-analysis. Crit Care. 2018 Feb 6;22(1):28. doi: 10.1186/s13054-018-1952-x.
PubMed 29409518
Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. doi: 10.1093/qjmed/94.10.521.
PubMed 11588210
Smith GB, Prytherch DR, Meredith P, Schmidt PE, Featherstone PI. The ability of the National Early Warning Score (NEWS) to discriminate patients at risk of early cardiac arrest, unanticipated intensive care unit admission, and death. Resuscitation. 2013 Apr;84(4):465-70. doi: 10.1016/j.resuscitation.2012.12.016. Epub 2013 Jan 4.
PubMed 23295778
Kramer AA, Sebat F, Lissauer M. A review of early warning systems for prompt detection of patients at risk for clinical decline. J Trauma Acute Care Surg. 2019 Jul;87(1S Suppl 1):S67-S73. doi: 10.1097/TA.0000000000002197.
PubMed 31246909

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
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All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: La Sepsi Nel Paziente Anziano: Studio Prospettico Sui Pazienti Ricoverati in Ambiente Internistico.
ClinicalTrials.gov ID: NCT04945889
Acronym / sponsor ID: 0069708/2019
Conditions: Sepsis
Keywords: Sepsis, Diagnostic accuracy, Geriatric patients, Older adults, Early Warning Score, qSOFA
Study type: Observational
Recruitment status: Completed
Enrolment: 580 participants (actual)
Lead sponsor: A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
Study start: 1 Apr 2019 (actual)
Primary completion: 31 Oct 2019 (actual)
Study completion: 31 Oct 2019 (actual)
First posted: 30 Jun 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.

Published studies on these scores included generally younger, selected subjects, not fully representative of the population at risk for sepsis.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Geriatric inpatients at risk for sepsis	–	Diagnostic Test: Quick Sequential Organ Failure Assessment (qSOFA), Diagnostic Test: Modified Early Warning Score (MEWS), Diagnostic Test: National Early Warning Score (NEWS)Consecutive patients admitted to an Acute Geriatric Unit for any reason presenting at least one National Institute for Health and Care Excellence (NICE) risk factor for sepsis (age ≥75 years, impaired immune function, long-term corticosteroid therapy, immunosuppressive or antineoplastic drug treatment, surgery or other invasive procedures within 6 weeks, any breach of skin integrity, intravenous drug misuse, indwelling lines or catheters). In those with suspected infection (i.e. antibiotic prescription and a culture test within 24 hours before-72 hours after), clinical parameters (respiratory rate, blood pressure, heart rate, body temperature, peripheral oxygen saturation, mental status) were assessed at least twice daily throughout hospital stay and used by study investigators to determine the qSOFA, NEWS and MEWS.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult
Study population: Older patients admitted for any cause, to an acute geriatric ward of a large university teaching hospital in North-western Italy, with at least one NICE risk factor for sepsis, providing written informed consent. Intervention (diagnostic test administration) was performed only in patients with a suspected infection, defined as the prescription of an oral and/or parenteral antibiotic therapy within a timeframe spanning from 24 hours before and 72 hours after the collection of a biological sample to perform a culture test.

Key inclusion criteria (2 listed)

Hospitalization in the Acute Geriatric Unit
Presence of at least one National Institute for Health and Care Excellence (NICE) guidance risk factor for sepsis (i.e. age ≥75 years, impaired immune function - diabetes mellitus, previous splenectomy, hematologic diseases - long-term corticosteroid therapy, immunosuppressive or antineoplastic drug treatment, surgery or other invasive procedures in the previous 6 weeks, any breach of skin integrity - e.g. pressure ulcers - intravenous drug misuse, indwelling lines or catheters)

Key exclusion criteria (1 listed)

Refusal to give written informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quick Sequential Organ Failure Assessment (qSOFA)Also: Quick Sepsis-Related Organ Failure AssessmentClinical bedside tool that evaluates three vital parameters, scoring one point each if altered: respiratory rate (RR) ≥22 breaths/minute, systolic blood pressure (SBP) ≤100 mmHg and altered mental status (defined in our study as either Glasgow Coma Scale (GCS) score <15 or any worsening in the Italian Oriented, Disoriented, Agitated, Sleepy scale). A qSOFA score ≥2 points is considered indicative of sepsis.	Diagnostic test	Geriatric inpatients at risk for sepsis
Modified Early Warning Score (MEWS)Clinical bedside tool that evaluates five vital parameters, with multiple scoring according to alteration: respiratory rate (0-3 points), heart rate (0-3 points), systolic blood pressure (0-3 points), body temperature (0-2 points), mental status (0-3 points, evaluated using the Alert, Verbal, Pain, Unresponsive - AVPU scale). A MEWS score ≥5 points is considered indicative of an acute condition at risk of sudden clinical deterioration.	Diagnostic test	Geriatric inpatients at risk for sepsis
National Early Warning Score (NEWS)Clinical bedside tool that evaluates seven parameters, with multiple scoring according to alteration: respiratory rate (0-3 points), oxygen saturation (0-3 points), need for any supplemental oxygen (0-2 points), body temperature (0-3 points), heart rate (0-3 points), systolic blood pressure (0-3 points), mental status (0-3 points, evaluated using the Alert, Verbal, Pain, Unresponsive - AVPU scale). A NEWS score ≥7 points is considered indicative of an acute condition at risk of sudden clinical deterioration.	Diagnostic test	Geriatric inpatients at risk for sepsis

Primary outcome

Sepsis diagnosis at discharge
Time frame: 10 days from enrollment in mean (discharge from hospital)
Presence in discharge documents of International Classification of Diseases 9th revision, Clinical Modification (ICD-9-CM) codes at discharge of either severe sepsis (995.92) or septic shock (785.52) or as the simultaneous presence in discharge documents of ICD-9-CM codes of infection and at least one acute organ dysfunction (Angus method).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
Results publication: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
Results publication: PubMed 11445675Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
Results publication: PubMed 29079157Rowe TA, McKoy JM. Sepsis in Older Adults. Infect Dis Clin North Am. 2017 Dec;31(4):731-742. doi: 10.1016/j.idc.2017.07.010.
Results publication: PubMed 26903335Seymour CW, Liu VX, Iwashyna TJ, Brunkhorst FM, Rea TD, Scherag A, Rubenfeld G, Kahn JM, Shankar-Hari M, Singer M, Deutschman CS, Escobar GJ, Angus DC. Assessment of Clinical Criteria for Sepsis: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):762-74. doi: 10.1001/jama.2016.0288.
Results publication: PubMed 29409518Song JU, Sin CK, Park HK, Shim SR, Lee J. Performance of the quick Sequential (sepsis-related) Organ Failure Assessment score as a prognostic tool in infected patients outside the intensive care unit: a systematic review and meta-analysis. Crit Care. 2018 Feb 6;22(1):28. doi: 10.1186/s13054-018-1952-x.
Results publication: PubMed 11588210Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. doi: 10.1093/qjmed/94.10.521.
Results publication: PubMed 23295778Smith GB, Prytherch DR, Meredith P, Schmidt PE, Featherstone PI. The ability of the National Early Warning Score (NEWS) to discriminate patients at risk of early cardiac arrest, unanticipated intensive care unit admission, and death. Resuscitation. 2013 Apr;84(4):465-70. doi: 10.1016/j.resuscitation.2012.12.016. Epub 2013 Jan 4.
Results publication: PubMed 31246909Kramer AA, Sebat F, Lissauer M. A review of early warning systems for prompt detection of patients at risk for clinical decline. J Trauma Acute Care Surg. 2019 Jul;87(1S Suppl 1):S67-S73. doi: 10.1097/TA.0000000000002197.
NICE sepsis guidanceLink provided by the sponsor.
NEWSLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Sepsis

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
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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.

Mario Bo, MD, PhD principal investigator

A.O.U. Città della Salute e della Scienza

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, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.

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 2 inclusion and 1 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: finished, as of the sponsor's last update on 30 Jun 2021. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Sepsis diagnosis at discharge (time frame: 10 days from enrollment in mean (discharge from hospital)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04945889, which also lists 8 linked publications.

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 30 Jun 2021.