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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT01654003
Eligibility Criteria:
Inclusion Criteria:
* Adults \> 18 years
* Severe sepsis\* as defined by the ACCCP/SCCM consensus conference
* Need for emergent interventional procedure under general anesthesia with an expected duration \> 120 min (in and out patients).
Exclusion Criteria:
* Patients responding to early fluid resuscitation (20ml/kg) who don't require a CVC
* Neurotrauma (Glasgow Coma Score \< 12) and/ or medullar trauma
* Known pregnancy or diagnosed by US or Ct-scan (\> 14 weeks)
* Sustained cardiac arrhythmia (see Logbook P8)
* Known or diagnosed severe cardiac valvular dysfunction (stenosis, insufficiency) (see Logbook P8)
* Known or diagnosed intracardiac shunt: interventricular or atrial defect (see Logbook P8)
* Burn injury \> 10%
* Needed emergency thoracotomy or ABC resuscitation protocol
* Pre-existing severe liver dysfunction(Child-Pugh class C)
* Do-not-resuscitate order, died within 48h of admission
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01654003
Study Brief:
Protocol Section:
NCT01654003