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Angiotensin II for Sepsis

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

Approved for 5 Other Conditions

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

All Individual Drugs Already Approved

Summary

This trial is testing Angiotensin II as an additional treatment for septic shock patients who don't respond to standard care. These patients need another option because their blood pressure remains low despite usual treatments. Angiotensin II helps by tightening blood vessels to raise blood pressure. Angiotensin II was approved to increase blood pressure in adults with septic or other distributive shock.

Eligible Conditions

Sepsis

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and though study completion, up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of patients who achieve blood pressure (BP) goal (MAP ≥65 mmHg) at 3 hours post-drug initiation

Secondary study objectives

Acute Kidney Injury (AKI)

BP goal at other time points

Change in catecholamine dose

+11 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial 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

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