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:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
NCT ID:
NCT06234592
Eligibility Criteria:
Inclusion Criteria:
* Within 48 hours of intensive care admission
* Evidence of suspected or confirmed infection
* Sequential Organ Failure (SOFA) score increase of 2 or more (assuming a baseline of 0 if no previous measures)
* Requirement for norepinephrine infusion as the sole vasopressor agent in a dose of \>0.1mcg/kg/min
* Lactate \>2mmol/L at any stage prior to randomisation
Exclusion Criteria:
* Known intolerance to Sonovue™ contrast medium, vasopressin or angiotensin II
* Patients receiving other vasoactive drugs in addition to norepinephrine
* Patients with known chronic kidney disease (CKD) stage 4 or 5 (baseline glomerular filtration rate (GFR) \<30mls/min)
* Patients receiving extra corporal membrane oxygenation (ECMO)
* Patients with acute occlusive coronary syndromes requiring intervention
* Patients with mesenteric ischaemia
* Patients with a history or presence of aortic dissection or abdominal aortic aneurysm
* Patients with Raynaud's syndrome or acute vaso-occlusive conditions
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06234592
Study Brief:
Protocol Section:
NCT06234592