Mechanistic Assessment of Norepinephrine Therapy vs. Angiotensin-II in Septic Shock

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06746753
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Septic Shock

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Angiotensin II — DRUG
    randomized to receive Angiotensin II continuous infusion for up to 48 hours
  • Norepinephrine — DRUG
    randomized to receive Norepinephrine continuous infusion for up to 48 hours

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Oct 7, 2028

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Angiotensin II
    Continuous infusion of Angiotensin II for up to 48 hours
  • Active Comparator: Norepinephrine
    Continuous infusion of Norepinephrine for up to 48 hours

Primary Outcome Measure

Mean Renin Level - Hour 24 [ Time Frame: Hour 24 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital-HarvardBostonMassachusetts02114
Michael R Filbin, MD, MS
[email protected]
Daniel E Leisman, MD
[email protected]
Michael R Filbin, MD, MS (PRINCIPAL_INVESTIGATOR)
Daniel E Leisman, MD (PRINCIPAL_INVESTIGATOR)
Marcia Goldberg, MD (SUB_INVESTIGATOR)
Kathryn Hibbert, MD (SUB_INVESTIGATOR)
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157
Ashish Khanna, MD
[email protected]
513-658-5866
Lynnette C Harris, BSN
[email protected]
336-716-8791
Ashish Khanna, MD (PRINCIPAL_INVESTIGATOR)
Christopher Schaich, PhD (SUB_INVESTIGATOR)
Daniel C Files, MD (SUB_INVESTIGATOR)
Mark Chappell, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital-Harvard· Boston, MAAtrium Health Wake Forest Baptist· Winston-Salem, NC

Related Studies