OXYGEN in high pressure in treatment of severe sepsis
- Conditions
- Patients > 18 yr. with diagnostic criteria for severe sepsis, within 6 hours of admission in the Emergency Room, defined as hypotension after hemodynamic resuscitation, initial lactate > 4, or persistence of organ dysfunction (oliguria < 0.5 ml/kg/h, cyanosis, or altered consciousness).(qSOFA 1, 2 or 3)Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2018-000634-35-ES
- Lead Sponsor
- Althaia Xarxa Assistencial Universitària de Manresa. Fundació Privada.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 592
Patients > 18 years, with diagnostic criteria of severe sepsis in the first 6 hours after admission to the Emergency Room defined as hypotension after hemodynamic resuscitation, initial lactate> 4, or persistence of organic dysfunction (oliguria <0.5 ml / kg / hour, cyanosis, lividities, altered consciousness
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 592
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Patients requiring immediate ventilatory support, both invasive and non-invasive, defined by severe hypoxemia (PaO2 / FiO2 <150), severe tachypnea (40x ') with signs of respiratory fatigue or low level of consciousness (Glasgow <8).
- Patients with limited therapeutic effort or orders of non-CPR.
- Patients not susceptible to treatment with OAF (facial trauma, tracheostomized, rejection of previous treatments with OAF).
- Participation in other clinical trials that may affect survival.
-Pregnant women.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Improve in-hospital mortality from 30% basal to 20% with high-flow oxygen therapy in patients with severe sepsis, measured from the signing of the consent to hospital discharge.;Secondary Objective: Reduce the need for mechanical ventilation, measured as days free of mechanical ventilation in the first 28 days.<br>- Reduce the need for dialysis, measured as dialysis-free days in the first 28 days.<br>- Reduce the need for vasoactive drugs, measured as the days free of vasoactive drugs in the first 28 days.<br>- Reduce organic failures, measured by SOFA scale during the first 28 days.<br>- Physiological: improve acidosis, clearance of lactate, and SvcO2 in the first 72 hours.;Primary end point(s): Mortality;Timepoint(s) of evaluation of this end point: During the hospitalization
- Secondary Outcome Measures
Name Time Method Secondary end point(s): In the first 28 days: need for mechanical ventilation, dialysis, vasoactive drugs, organic failure according to the SOFA scale. In the first 72 hours: improvement of acidosis, clearance of lactate and SvO2;Timepoint(s) of evaluation of this end point: In the first 28 days