NCT06746753

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

Mechanistic Assessment of Norepinephrine TheRapy vs. Angiotensin-II in Septic Shock (MANTRA) Grant Submission- Dysfunctional Renin-Angiotensin System in Septic Shock

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will determine whether normalization of renin-angiotensin-aldosterone system (RAAS) signaling in sepsis occurs more rapidly with treatment with Angiotensin II compared with conventional vasopressors. Trial samples will be used to identify the best RAAS biomarker predictor of treatment response via in-depth longitudinal analysis of RAAS component and to determine the extent and mechanisms of Angiotensin II impact on innate immune function during sepsis. Successful accomplishment of our aims will provide the capability to improve endotyping of septic patients by establishing the most precise and robust measurement of renin (and RAAS dysfunction). This work will improve staging and clinical precision and will facilitate the criteria for therapeutic development of targets in septic shock.

Conditions

• Septic Shock

Interventions

Type	Name	Description
DRUG	Angiotensin II	randomized to receive Angiotensin II continuous infusion for up to 48 hours
DRUG	Norepinephrine	randomized to receive Norepinephrine continuous infusion for up to 48 hours

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-07-01
• Completion: 2028-08-01
• First posted: 2024-12-24
• Last updated: 2026-03-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study