Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT01747057
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Clinical evidence of sepsis (microbiology confirmation, radiological or direct view - pus in biological fluid or surgical direct view-).
* ≥ 2 SIRS criteria:
* Temperature \< 36.0°C or \> 38.0°C
* Heart rate \> 90 bpm
* Respiratory rate \> 20 rpm or PaCO2 \< 32 mmHg or need of mechanical ventilation.
* Leukocytes \> 12.0 x109/L or \< 4.0 x109/L
* Hemodynamic insufficiency defined as (at least one of the following):
* Sustained systemic hypotension (systolic arterial pressure ≤ 90 mmHg or MAP \< 65 mmHg) or a decrease in MAP of \> 30 mm Hg in a hypertensive patient.
* Need of vasopressors.
* Tachycardia (HR \> 110 bpm) or bradycardia (HR \< 55 bpm)
* Acute onset of oliguria, defined as a decreased urine output \< 0.5 ml/kg/hr for ≥ 2 hours
* Serum lactate \> 2 mmol/l
* Peripheral cyanosis, mottled skin, prolonged capillary refill
* Mechanical ventilation without any kind of inspiratory effort and Vt 7-10 mL/Kg, Pplateau \< 30 mmH2O. Those patients with ARDS under mechanical ventilation will need to tolerate a tidal volume of at least 7 mL/Kg during 30 seconds while the plateau pressure remains \< 30 mmH2O.
* Prior hemodynamic monitoring by arterial catheter.
* Central venous catheter.
Exclusion Criteria:
* Acute myocardial infarction \< 7 days.
* Pregnancy
* Prior request of limited code status or expected life length lower than 3 months.
* Shock \> 12h
* Cardiac arrhythmia
* Aortic valvular disease
* Inability to properly measure arterial pressure wave forms
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01747057
Study Brief:
Protocol Section:
NCT01747057