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Vasopressor

Angiotensin II for Septic Shock (DARK-Sepsis Trial)

Phase 4

Recruiting

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 72 hours post drug initiation or soc equivalent

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare angiotensin II to current treatment for shock, to see if novel biomarkers can predict blood pressure response. Unblinded study.

Who is the study for?

Adults over 18 with persistent vasodilatory shock despite certain treatments, who have specific catheters in place and are not fluid responsive. They must be able to consent or have a representative do so, and not fall under exclusion criteria like acute stroke, severe liver failure, high-dose steroid use, extensive burns, very low neutrophils count, active bleeding with low hemoglobin levels or conditions contraindicating blood sampling.

What is being tested?

The trial is testing if angiotensin II can better manage blood pressure in adults with septic shock compared to standard vasopressor therapy. It's also looking at whether two biomarkers can predict the response to this treatment. This unblinded study randomly assigns participants to either receive angiotensin II or stick with the usual care.

What are the potential side effects?

Potential side effects of angiotensin II may include increased blood pressure leading to possible cardiovascular events such as irregular heartbeats or chest pain; it might also affect kidney function and could cause allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours post drug initiation or soc equivalent

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours post drug initiation or soc equivalent

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours post drug initiation or soc equivalent for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Ability of baseline DPP3 to predict NED at 3 hours

Ability of baseline renin to predict norepinephrine equivalent dose (NED) at 3 hours

Secondary study objectives

Ability of changes in DPP3 level to predict NED at 3 hours

Ability of changes in renin level to predict NED at 3 hours

Ability of pre-baseline DPP3 to predict NED at 3 hours

+18 more

Other study objectives

Prespecified Adverse Events: atrial fibrillation

Prespecified Adverse Events: confirmed infection

Prespecified Adverse Events: hyperglycemia

+14 more

Awards & Highlights

Drug Has Already Been Approved

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

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Angiotensin IIExperimental Treatment1 Intervention

For patients randomized to the intervention group, once the dose of background norepinephrine reaches ≥0.10 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 to mean arterial pressure (MAP) goal of \>/= 65 mmHg according to the protocol titration scheme and in accordance with the University of New Mexico Hospital (UNMH) Nursing Department Titration Guideline. Angiotensin II treatment will be capped at 72 hours, at which point (if a second vasopressor is still needed) the patient will be started on an alternative agent.

Group II: Standard of Care (SOC)Active Control1 Intervention

Vasopressor therapy be titrated by the clinical team per usual SOC and UNMH Nursing Department Titration Guideline. using other available vasopressor agents (e.g., higher-dose norepinephrine, vasopressin, epinephrine, phenylephrine, and/or dopamine). To provide a comparator arm, patients in the SOC will have renin and DPP3 levels obtained at equivalent timepoints.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Angiotensin II

2010

Completed Phase 4

~260

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