Health TrialsbyHealthPanel

Early Angiotensin II in the Emergency Department

ConditionSeptic Shock
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorBrett A Faine

About this trial

This pilot study will enroll 20 patients with septic shock and require emergent vasopressor support in the emergency department (ED). The primary objective of the study is to determine the feasibility of early peripheral administration of angiotensin II for treatment of septic shock in the ED

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18; and

Requiring norepinephrine at a dose of 0.05-0.25 mcg/kg/min mcg/kg/minute despite adequate fluid resuscitation; and

Receiving intravenous antibiotics or clinician's intention to administer antibiotics at the time of enrollment; and

Can provide written informed consent (or legally authorized representative).

Disqualifiers

Acute coronary syndrome;

Cardiogenic shock;

Patients with a history of mesenteric ischemia;

Patients with a history of having an aortic dissection or abdominal aortic aneurysm;

Trial design

Design model

Single group

Treatments tested in this trial

  • Angiotensin II Infusion

    Drug

    Angiotensin II continuous infusion

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Angiotensin II InfusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of completing all clinical trial activities

Percentage of patients who provide informed consent and receive angiotensin II infusion in the emergency department

Time frame
From enrollment to the end of treatment up to 6 hours after the angiotensin II infusion is initiated

Secondary outcomes

1

Mean arterial pressure response

Change in mean arterial pressure

Time frame
60 minutes after the intiation of angiotensin II infusion
2

Mean norepinephrine dose (during angiotensin II infusion)

Change in norepinephrine dose (mcg/kg/minute) after the initiation of angiotensin II infusion

Time frame
60 minutes after the intiation of angiotensin II infusion
3

Mean norepinephrine dose (post angiotensin II infusion)

Mean norepinephrine dose (mcg/kg/minute) after the completion of the angiotensin II infusion

Time frame
60 minutes after the completion of the angiotensin II infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brett A Faine

Lead sponsor

University of Iowa

Sponsor institution

Source ClinicalTrials.gov
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