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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT04558359
Eligibility Criteria:
Inclusion Criteria:
* Medical ICU admission
* Septic shock
* Norepinephrine requirement = 0.15 mcg/kg/min for = 30 minutes (if cirrhosis, norepinephrine requirement = 0.1 mcg/kg/min for = 30 minutes)
* Kidney Disease Improving Global Outcomes stage 1 or greater Acute Kidney Injury
Exclusion Criteria:
* Prisoner
* Pregnancy
* Acute occlusive coronary syndrome requiring intervention or acute myocardial infarction of any degree
* Purely cardiogenic shock (no distributive component)
* Mesenteric ischemia
* Acute ischemic stroke
* Hemorrhagic shock
* Active treatment of hepatorenal syndrome targeting a Mean Arterial Pressure = 65 mm Hg
* Planned withdrawal of care within next 24 hours or no escalation of care
* Patient enrolled in an interventional study
* High likelihood of medical futility in using this drug:
* 3 or more vasopressors required to sustain MAP
* Sustained norepinephrine equivalents \> 0.5 mcg/kg/min
* COVID-19 positive, or high suspicion of COVID-19
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04558359
Study Brief:
Protocol Section:
NCT04558359