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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT02771002
Eligibility Criteria:
Septic patient:
Inclusion criteria:
* ICU admission with septic shock defined as:
* documented infection (suspected or confirmed) AND
* systemic mean blood pressure \<65mmHg requiring any dose of vasopressor despite adequate fluid resuscitation (min. 20ml/kg crystalloids) AND
* lactate \>2mmol/l
* Deferred consent by a relative with following informed consent by patient as documented by signatures (Appendix Informed Consent Form)
Exclusion criteria:
* Age \<18 or \>80 years
* present or suspected myocardial ischemia
* acute pulmonary embolism
* known liver disease - Child-Pugh -Class B or C
* known chronic renal failure
* known peripheral artery disease
Patient after cardiac surgery:
Inclusion criteria:
* ICU admission after coronary artery bypass grafting or valve surgery with cardiopulmonary bypass
* General consent with admission at the University hospital
Exclusion criteria:
* Age \<18 or \>80 years
* known peripheral artery disease
* no or only low dose of vasopressors (\<300µg/h) at ICU admission
* present or suspected myocardial ischemia
* acute pulmonary embolism
* known liver disease - Child-Pugh -Class B or C
* known chronic renal failure
Healthy volunteers:
Inclusion criteria:
\- Informed consent as documented by signature (Appendix Informed Consent Form)
Exclusion criteria:
* Age \<18 or \>80 years
* known peripheral artery disease
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02771002
Study Brief:
Protocol Section:
NCT02771002