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NCT06746753
Mechanistic Assessment of Norepinephrine Therapy vs. Angiotensin-II in Septic Shock
Conditions: Septic Shock
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 78
Sponsor: Wake Forest University Health Sciences
Location: Massachusetts General Hospital-Harvard Boston Massachusetts
Summary
Despite best therapy efforts, sepsis and septic shock are associated with mortality rates of up to 40%. This clinical trial will determine the benefit of exogenous Angiotensin II versus norepinephrine (conventional care) treatment in septic shock patients. This trial will determine whether there are better predictors of septic shock severity. This approach may inform more appropriate treatment regimens and improve outcomes for these patients.
Eligibility Criteria
Inclusion Criteria:
\- The presence of septic shock, defined by sepsis-3 criteria: 1-adult patients (18 years or older) with septic shock, defined by SEPSIS-3 criteria: a) suspected or known infection, b) hypotension requiring vasopressors, and c) lactate \>2mmol/L 2-receiving either norepinephrine or phenylephrine with or without additional vasopressor support 3- total norepinephrine equivalent dose (NED) ≥0.1 mcg/kg/min and ≤0.5 mcg/kg/min, to maintain a MAP of at least 65 mmHg, is required for randomization 4-ability to consent and randomize within 24 hrs of first reaching NED threshold and within 48 hrs of hospital arrival
Exclusion Criteria:
* Age \
Source: ClinicalTrials.gov (NCT06746753). StuddyBuddy aggregates publicly available trial information.