Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ferring Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
18 years of age or older
Proven or suspected infection
Septic shock defined as hypotension requiring vasopressor treatment despite adequate fluid resuscitation
Informed consent obtained in accordance with local regulations
You may not be if
Not possible to initiate trial drug treatment within 12 hours from onset of vasopressor treatment for septic shock
Primary cause of hypotension not due to sepsis
Previous severe sepsis with intensive care unit admission within this hospital stay
Known/suspected acute mesenteric ischaemia
Suspicion of concomitant acute coronary syndrome based on clinical symptoms and/or ECG during this episode of septic shock
Chronic mechanical ventilation for any reason OR severe chronic obstructive pulmonary disease (COPD) requiring either continuous daily oxygen use during the preceding 30 days or mechanical ventilation (for acute exacerbation of COPD) during the preceding 30 days
Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia
Known to be pregnant
Decision to limit full care taken before obtaining informed consent
Use of vasopressin in the past 12 hours prior to start of trial drug treatment or use of terlipressin within 7 days prior to start of trial drug treatment
Prior enrolment in the trial
Prior use of an investigational medicinal product within the last month OR planned or concurrent participation in a clinical trial for any investigational drug or investigational device
