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

Study acronym: MANTRA
StatusNot Yet Recruiting
PhasePhase 4
Started
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Record History

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  1. Notable Start date: Sep 2026 to Nov 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 50 of 69 entries
  2. Notable Start date: Jul 2026 to Sep 2026v12
  3. Minor Primary completion pushed from Jul 2028 to Sep 30, 2028
    • Study completion pushed from Aug 2028 to Oct 7, 2028
    v11
  4. Notable Start date: May 2026 to Jul 2026v10
  5. Notable Start date: Mar 2026 to May 2026
    • Secondary endpoints: 57 to 69
    • Collaborator revised
    • Study title expanded, about 4 words
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Study sites: 1 to 2
    • Eligibility criteria expanded, about 61 words
    • Secondary endpoints: details revised at 4 of 57 entries
    v8
  2. Minor Primary completion date: Dec 2028 to Jul 2028
    • Study completion date: Dec 2030 to Aug 2028
    • Start date: Jan 2026 to Mar 2026
    v7
  3. Minor Re-verified, no change to tracked fieldsv6
  4. Notable Primary completion date: Dec 2026 to Dec 2028
    • Study completion date: Dec 2026 to Dec 2030
    • Collaborators expanded, about 5 words
    v5
  5. Notable Start date: Jul 2025 to Jan 2026v4
  6. Notable Start date: Mar 2025 to Jul 2025v3
  7. Minor Primary and study completion dates: Dec 1, 2026 to Dec 2026
    • Start date: Mar 1, 2025 to Mar 2025
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06746753
Lead Sponsor Wake Forest University Health Sciences
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)
Septic Shock
Related terms Kidney Diseases, Sepsis, Shock, Septic
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov