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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT03643367
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients, age 18 to 80 years
* Intensive care Unit (ICU) patients with septic shock (despite fluid resuscitation vasopressors needed to maintain mean arterial pressure ≥65 millimeter of mercury (mmHg), and serum lactate \>2mmol/l even with fluid application)
* Treatment of septic shock on ICU with vasopressors not longer than 12 hours
* Sedation and mechanical ventilation on ICU
* Female patients of childbearing potential with negative pregnancy test
* Informed Consent as documented by signature
Exclusion Criteria:
* Previous surgery and/or anesthesia (within last 7 days)
* Application of nitric oxide (NO)
* Suspected or known intolerance by history to volatile anesthetics (malignant hyperthermia)
* Immunosuppressive agents
* Systemic corticosteroids in the phase before hospitalization (\> 10mg/d prednisone)
* Significant concomitant disease (acute cerebral vascular event, acute coronary syndrome, decompensated heart failure, acute pulmonary edema, major cardiac arrhythmia, seizure, burn, chronic kidney disease, end stage liver failure, neuromuscular disease)
* AIDS
* Autoimmune disease
* Organ transplant
* Subject with active malignancy receiving
* chemotherapy or radiation treatment within last 60 days
* Hepatitis B/C virus infection
* Anti-tumor necrosis factor (TNF) therapy
* Pregnancy and/or Breast feeding
* Use of cytokine absorber
* Enrollment in any other clinical trial during the course of this trial, 30 days prior to its beginning or 30 days after its completion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03643367
Study Brief:
Protocol Section:
NCT03643367