Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study

Completed · Phase 1

Conditions studied: Septic Shock

In brief

The investigators propose a dose finding study to determine the feasibility of Angiotensin II (AII) to increase mean arterial pressure in high-output shock. If AII can be shown to increase mean arterial pressure, this could lead to future pharmacologic development based on the AII hormonal pathway. The investigators propose a 20 patient, randomized, placebo-controlled, blinded study in the treatment of high-output shock. Patients with high-output shock and a cardiovascular SOFA (sequential organ failure score) score of \> 4 will be eligible. In addition, patients must already be receiving cardiac output monitoring and have a cardiac index \> 2.4 L/min/ 1.73 m2. Patients will be randomized to intravenous AII or saline in a blinded fashion. There will be 10 patients in each arm. This is a safety and dose finding feasibility study. The investigators are starting with a small cohort consistent with similar types of studies. The investigators estimate that ten patients in each arm will generate a basis for determining if there is sufficient signal for AII to improve blood pressure at the doses outlined. The primary endpoint in the study will be the effect of AII on the standing dose of norepinephrine which is required to maintain a mean arterial pressure (MAP) of 65 mmHg. Secondary endpoints will be the effect of AII on urine output, serum lactate, and creatinine clearance. 30 day post dose mortality will also be assessed. Subjects discharged prior to day 30 will be contacted by telephone for this assessment.

Key facts

Study ID: NCT01393782
Run by: George Washington University
People needed: 20
Starts: 2011-07-01
Expected to finish: 2014-01-01
Last updated by the study team: 2024-04-12

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

High-output shock
Cardiovascular SOFA score of > 4
Cardiac Index > 2.4 liters/min/BSA 1.73m2
Indwelling arterial line already present as part of standard care
Age > 21 years of age
Signed consent form
Use of indwelling urinary catheter as standard care expected at least for 12 hours during the study interventions

You may not qualify if…

Patients with acute coronary syndrome
Patients with a known history of vasospasm
Patients with a history of asthma
Patients currently experiencing bronchospasm
Patients with active bleeding with an anticipated need for > 4 units of PRBC or Hemoglobin < 7g/dL or any other condition that would contraindicate drawing serial blood samples

Where it is running

GW University — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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