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 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT01089361
Eligibility Criteria:
Inclusion Criteria:
* Patients meeting the ACCP/ SCCM definition of severe sepsis will be enrolled in the study. These patients should have a known or suspected source of infection.
* Patients within 12 hours of the development of one or more organ dysfunctions
* Patients must exhibit 3 or more of the following signs of clinical inflammation:
* Core temperature \< 36ºC or \> 38ºC.
* Heart rate of 90 or greater not explained by another medical condition.
* A respiratory rate of \> 20 min-1, a PaCO2 \< 32min-1 or the need for mechanical ventilation.
* A white blood cell count of \< 4000 cell/ml or \> 12000 cells/ml or a WBC showing greater then 10% immature neutrophils.
Exclusion Criteria:
* pregnant
* increased intracranial pressure or closed head injury
* history of psychotic mental disease
* receiving Continuous Veno - Venous Hemofiltration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
100 Years
Study:
NCT01089361
Study Brief:
Protocol Section:
NCT01089361