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:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
NCT ID:
NCT01449916
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or older
* Suspected infection
* 2 or more of SIRS criteria:
* Heart rate \>90/min
* Respiratory rate \>20/min
* Temperature \>= 38° C or \<= 36° C
* White blood count \> 12,000 or \< 4,000/µL
* 1 or more of the following signs of end-organ dysfunction
* Systolic blood pressure \< 90 mm Hg
* Mean arterial blood pressure (MAP) \< 65 mm Hg
* Confusion/altered mentation
* Urine output \< 0.5 mL/kg/hr
* Creatinine increase \> 0.5 mg/dL
* Creatinine \> 0.5 mg/dL above upper limit of normal
* Platelet \< 100x109/L
* Respiratory rate \> 40/min
* Jaundice
Exclusion Criteria:
* GI bleed
* Need for urgent surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01449916
Study Brief:
Protocol Section:
NCT01449916