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Completed

NCT Number: NCT02926664

Delta qSOFA for Risk Stratification in Emergency Infected Patients

The study will investigate the prognostic value of qSOFA (quick Sequential Organ Failure Assessment) kinetics between H0 and H1, and between H0 and H3 in patients with suspicion of Sepsis, i.e. an initial qSOFA of at least of 2.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques St Luc, Brussels, Belgium

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About this study

qSOFA has been reported as a good tool for risk stratification in the ED for patients with infection.

However, it is not clear whether qSOFA remains stable during the ED stay, nor whether its kinetics can have prognostic added value.

Patients with a qSOFA of at least 2 in the ED, and suspicion of infection will be included.

After treatment is initiated and fluids challenge performed, we will collect qSOFA value at 1 hour and 3 hours.

Our hypothesis is that a decrease in qSOFA between H0 and H3 is associated with better outcome. We assume that 50% of patients will have a deltaqSOFA >0, with an overall mortality of 23% (according to previous cohort). Under the hypothesis of difference of at least 15% in mortality between the two groups (DeltaqSOFA > 0 and Delta qSOFA<=0), with a power of 90% and an alpha of 0.05, we need to recruit 322 patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • suspicion of infection by the emergency physicians
  • at least two of the following criteria : respiratory rate <= 22, systolic blood pressure <= 100 mmHg and altered mental status

Exclusion criteria

  • Infection ruled out by the expert after chart review
  • patient who refuse to participate

Treatment and study plan

measurement of qSOFA

Other

qSOFA will be measured at H0, H1 and H3

Primary outcomes

  1. In-hospital mortality

    Time frame: 60 days

Secondary outcomes

  1. ICU admission more than 72 hours

    Time frame: 60 days

  2. ICU admission

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

Societe Française de Medecine d'urgence

Other

Registry information

Official study title

Prognostic Value of Quick Sequential Organ Failure Assessment Kinetics After Fluids Challenge in the Emergency Department

Acronym: DELTASCREEN

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 6, 2016
Registry last updated
Oct 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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