An observational study in Sepsis and Septic Shock, sponsored by Aseer Central Hospital. Completed at 20 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Aseer Central Hospital · Observational
Early identification of a patient with infection who may develop sepsis is of utmost importance. Unfortunately, this remains elusive because no single clinical measure or test can reflect complex pathophysiological changes in patients with sepsis. However, multiple clinical and laboratory parameters indicate impending sepsis and organ dysfunction. Screening tools using these parameters can help identify the condition, such as SIRS, quick SOFA (qSOFA), National Early Warning Score (NEWS), or Modified Early Warning Score (MEWS). The 2016 SCCM/ESICM task force recommended using qSOFA, while the 2021 Surviving Sepsis Campaign strongly recommended against its use compared with SIRS, NEWS, or MEWS as a single screening tool for sepsis or septic shock. We hypothesised that qSOFA has greater prognostic accuracy than SIRS and EWS (NEWS/NEWS2/MEWS).
Over the past decade, medical advances in sepsis continued to focus on sepsis as a prevalent condition that accounts for 10% of admissions to intensive care units (ICUs) and is associated with a 10-20% in-hospital mortality rate. Standardised protocols and physician awareness have significantly improved survival, but mortality rates remain between 20% and 36%, with \~270,000 deaths annually in the United States. However, of patients with sepsis, 80% are treated in an emergency department (ED), and the remainder develops sepsis during hospitalisation with other conditions. In 2016, the Society of Critical Care Medicine/European Society of Intensive Care Medicine (SCCM/ESICM) task force redefined sepsis based on organ dysfunction and mortality prediction. Sepsis now is defined as life-threatening organ dysfunction caused by dysregulated host response to infection. This definition emphasises the complexity of the disease that cannot be explained by infection or body response to it. Acute change in Sequential Organ Failure Assessment (SOFA) score ≥2 indicates sepsis-related organ dysfunction, a predictor of excess in-hospital mortality. Systemic Inflammatory Response Syndrome (SIRS) and "severe sepsis" terms were omitted from the most recent definition. SIRS has been criticised for its poor specificity, while "severe sepsis" may underestimate sepsis's seriousness. A subset of patients may develop septic shock with underlying profound organ dysfunction and excess mortality. Clinically, septic shock is defined as persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mm Hg and serum lactate level ≥ 2 mmol/L (18 mg/dL) despite adequate volume resuscitation. Early identification of a patient with infection who may develop sepsis is of utmost importance. Unfortunately, this remains elusive because no single clinical measure or test can reflect complex pathophysiological changes in patients with sepsis. However, multiple clinical and laboratory parameters indicate impending sepsis and organ dysfunction. Screening tools using these parameters can help identify the condition, such as SIRS, quick SOFA (qSOFA), National Early Warning Score (NEWS), or Modified Early Warning Score (MEWS). The 2016 SCCM/ESICM task force recommended using qSOFA, while the 2021 Surviving Sepsis Campaign strongly recommended against its use compared with SIRS, NEWS, or MEWS as a single screening tool for sepsis or septic shock. We hypothesised that qSOFA has greater prognostic accuracy than SIRS and EWS (NEWS/NEWS2/MEWS).
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's enrollment of 3,274 is above the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Aseer Central Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
All consecutive adult patients (age ≥18 years) presenting to the ED with suspected infection who planned to be hospitalized and willing to give informed consent (if required by recruiting center IRB) are eligible. A presumptive diagnosis of infection will be judged based on the opinion of the emergency physician upon the initial patient presentation to the ED. We will exclude patients with evidence of other causes of presentation to the ED other than infection (e.g., autoimmune diseases, myocardial infarction, trauma, ...etc.), pregnant ladies, those who transferred from other hospitals, those not planned for hospitalization, or those who admitted electively to the hospital through ED. We will also exclude patients whose initial diagnosis of infection in the ED was not confirmed after the recruitment and follow-up.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients with suspected infection and a qSOFA score ≥ 2 at the triage in the ED who are planned for hospitalization
Diagnostic Test: Measurement of qSOFA score
Adult patients with suspected infection and a qSOFA score \< 2 at the triage in the ED who are planned for hospitalization
Diagnostic Test: Measurement of qSOFA score
Adult patients with suspected infection and a SIRS criteria ≥ 2 at the triage in the ED who are planned for hospitalization
Diagnostic Test: Measurement of SIRS criteria
Adult patients with suspected infection and a SIRS criteria \< 2 at the triage in the ED who are planned for hospitalization
Diagnostic Test: Measurement of SIRS criteria
Adult patients with suspected infection and a NEWS ≥ 5 or red score (i.e., a score of 3 in any one parameter) at the triage in the ED who are planned for hospitalization
Diagnostic Test: Measurement of NEWS
Adult patients with suspected infection and a NEWS \< 5 at the triage in the ED who are planned for hospitalization
Diagnostic Test: Measurement of NEWS
Adult patients with suspected infection and a NEWS2 ≥ 5 or red score (i.e., a score of 3 in any one parameter) at the triage in the ED who are planned for hospitalization
Diagnostic Test: Measurement of NEWS2
Adult patients with suspected infection and a NEWS2 \< 5 at the triage in the ED who are planned for hospitalization
Diagnostic Test: Measurement of NEWS2
Adult patients with suspected infection and a MEWS ≥ 5 at the triage in the ED who are planned for hospitalization
Diagnostic Test: Measurement of MEWS
Adult patients with suspected infection and a MEWS \< 5 at the triage in the ED who are planned for hospitalization
Diagnostic Test: Measurement of MEWS
At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's qSOFA score.
Also known as: quick Sequential Organ Failure Assessment (qSOFA)
At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's SIRS criteria.
Also known as: Systemic inflammatory response syndrome (SIRS)
At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's NEWS.
Also known as: National Early Warning Score (NEWS)
At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's NEWS2.
Also known as: National Early Warning Score 2 (NEWS2)
At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's MEWS.
Also known as: Modified Early Warning Score (MEWS)
In-hospital mortality
Mortality rate during hospitalization of patient
Time frame: 30 days
Intensive care unit admission
Number of participants admitted to an intensive care unit
Time frame: 30 days
Length of stay in the intensive care unit
Stay in intensive care unit \>72 hours
Time frame: 30 days
Plan to share: Undecided
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Aseer Central Hospital