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Angiotensin II for Septic Shock
Phase 4
Waitlist Available
Led By Joao P Teixeira, MD
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up though study completion, up to 1 year
Awards & highlights
Study Summary
This trial will compare the use of two drugs to raise blood pressure in patients who are still hypotensive despite using norepinephrine.
Eligible Conditions
- Septic Shock
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ though study completion, up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~though study completion, up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients who achieve blood pressure (BP) goal (MAP ≥65 mmHg) at 3 hours post-drug initiation
Secondary outcome measures
Acute Kidney Injury (AKI)
BP goal at other time points
Change in catecholamine dose
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: angiotensin II (intervention)Experimental Treatment1 Intervention
For patients randomized to the intervention group, once the dose of background norepinephrine reaches ≥0.2 mcg/kg/min for ≥30 minutes, angiotensin II will be started at a dose of 20 ng/kg/min (recommended starting dose in package insert). Thereafter, angiotensin II and norepinephrine will both be titrated according to the schema in UNM Hospitals Nursing Department Titration Guideline. Angiotensin II treatment will be capped at 72h, at which point (if a second vasopressor is still needed) the patient will be started on an alternative agent.
Group II: vasopressin (standard of care)Active Control1 Intervention
In patients randomized to the control group, once the dose of background norepinephrine reaches ≥0.2 mcg/kg/min for ≥30 minutes, vasopressin will be used at a fixed dose of 0.04 units/min and norepinephrine will be titrated per usual standard of care (as also outlined in the UNM Hospitals Nursing Department Titration Guideline).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Angiotensin II
FDA approved
Find a Location
Who is running the clinical trial?
National Center for Advancing Translational Sciences (NCATS)NIH
321 Previous Clinical Trials
401,749 Total Patients Enrolled
1 Trials studying Septic Shock
17 Patients Enrolled for Septic Shock
National Center for Advancing Translational Science (NCATS)NIH
99 Previous Clinical Trials
36,309 Total Patients Enrolled
1 Trials studying Septic Shock
17 Patients Enrolled for Septic Shock
University of New MexicoLead Sponsor
372 Previous Clinical Trials
3,528,789 Total Patients Enrolled
1 Trials studying Septic Shock
40 Patients Enrolled for Septic Shock
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