An interventional study of systematic calculation of qSOFA in Bacterial Infection and Intensive Care, sponsored by Centre Hospitalier Régional d'Orléans. Completed at 1 site in France. Open to participants aged 18 Years to 105 Years. Per ClinicalTrials.gov, last updated 2018-08-01.
Sponsored by Centre Hospitalier Régional d'Orléans · Not applicable, Interventional, and Diagnostic
The delayed administration of an adequate antimicrobial therapy is a strong predictor of impaired outcome in patients with bacterial sepsis. Therefore, the current Surviving Sepsis Campaign guidelines (2016) recommend that administration of intravenous antimicrobials be initiated within one hour following the recognition of sepsis or septic shock.
The quick Sepsis-related Organ Failure Assessment (qSOFA) score is a new bedside tool which has been recently proposed by the Third International Sepsis Consensus Definitions Task Force (Sepsis-3) to identify patients with suspected infection who are at greater risk for a poor outcome outside the Intensive Care Unit (ICU). It uses three criteria, assigning one point for low systolic blood pressure (SBP ≤100 mmHg), high respiratory rate (≥22 breaths per min) and altered mentation (Glasgow coma scale \<15). The score ranges from 0 to 3 points. A qSOFA value ≥2 points is associated with a greater risk of death or prolonged ICU stay, these outcomes being more common in infected patients who may be septic than in those with uncomplicated infection. The definite goal of qSOFA is to hasten the management and thus improve the outcome of patients at risk of sepsis or septic shock.
Many patients admitted to the hospital for bacterial sepsis or septic shock are initially managed in the Emergency Department (ED). This study aims at investigating whether the routine calculation of qSOFA at patient triage may hasten the initiation of antimicrobial therapy in patients admitted to the ED with suspected or proven bacterial infection, especially in those with subsequent criteria for sepsis or septic shock (Sepsis-3 definition).
584 studies on the registry are indexed under Bacterial Infections; 84 are open to participants now.
This study's enrollment of 780 is above the median of 84 across 382 interventional studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →Centre Hospitalier Régional d'Orléans is the lead sponsor of 132 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Usual procedure for patient triage AND systematic calculation of qSOFA at Emergency Department triage in patients admitted with a suspected or proven bacterial infection.
Procedure: systematic calculation of qSOFA
Usual procedures for patient triage at Emergency Department admission and management of suspected or proven bacterial infection. No systematic calculation of qSOFA.
calculation of qSOFA for each patient
Proportion of patients who receive a first dose of antimicrobial agent
Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) who receive a first dose of antimicrobial agent within one hour following triage in the emergency department.
Time frame: one hour
Proportion of patients who receive a first dose of adequate antimicrobial agent
Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) and microbiologically documented infection who receive a first dose of adequate antimicrobial agent within one hour following triage in the emergency department.
Time frame: one hour
Proportion of patients who receive a first dose of antimicrobial agent
Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) who receive a first dose of antimicrobial agent within 3 hours following triage in the emergency department.
Time frame: three hours
Proportion of patients who receive a first dose of adequate antimicrobial agent
Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) and a microbiologically documented infection who receive a first dose of adequate antimicrobial agent within 3 hours following triage in the emergency department
Time frame: three hours
Proportion of patients with a decrease in SOFA score value ≥ 1 point
Proportion of patients with a decrease in SOFA score value ≥ 1 point between triage in the emergency department (Day 0) and Day 2 among those with an initial SOFA score value ≥ 1 point
Time frame: two days
Proportion of patients requiring an admission to the Intensive Care Unit
Proportion of patients requiring an admission to the Intensive Care Unit between triage in the emergency department (Day 0) and Day 2
Time frame: two days
In-hospital mortality at day 7
Number of patients who died in hospital at day 7
Time frame: seven days
Overall In-hospital mortality
Number of patients who died in hospital during the hospital stay
Time frame: through hospital discharge, up to 3 months
Length of hospital stay
Number of days in hospital
Time frame: throught hospital discharge, up to 3 months
Ran from Oct 2017 to primary completion in Jun 2018, 7 months.
Of 56 non-industry interventional studies with no phase under Bacterial Infections, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 7 months is below that.
Counting every sponsor, half of 60 studies reached it within 25 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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