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:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT01775020
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent from close relative
* Age \> 18 years
* Patient meets the general criteria for severe sepsis or septic shock, diagnosed less than 48 h prior to study inclusion (see appendix A; in Dutch).
* Patient must be relatively hemodynamically stable, defined as stable blood pressure (variation in mean arterial pressure \<15 mm Hg) during 2 h without necessity of increasing the vasopressor dose, inotropic support or rate of fluid administration.
* Systemic and pulmonary arterial catheters in place with continuous pressure monitoring.
* Patients in whom the clinician is prepared to provide full life support during the duration of the study, including a life expectance of \> 24 h.
Exclusion Criteria:
* Shock due to any cause other than sepsis (e.g. drug reaction or drug overdose, pulmonary embolus, burn injury etc.)
* Corticosteroid use (prolonged intake of \> 1mg/kg daily or intake of \> 70 mg/day for 7 consecutive days within 1 month preceding the study)
* Liver cirrhosis
* Chronic pancreatitis
* Diabetes mellitus type I
* Metastases, haematological malignancies or chemotherapy
* Patients on dialysis (CVVH or other)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01775020
Study Brief:
Protocol Section:
NCT01775020