A Study of the Effect, Safety, and Tolerability of LJPC-501 in Patients with Catecholamine-Resistant Hypotension

Overview

About this study

The purpose of this study is to assess the effect, safety, and tolerability of LJPC-501 (angiotensin II) in adult patients diagnosed with catecholamine-resistant hypotension.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Adult patients ≥ 18 years of age
  • Have catecholamine-resistant hypotension defined as  requiring a total sum catecholamine dose of > 0.2 mcg/kg/min for a minimum of 6 hours and a maximum of 48 hours, to maintain a MAP between 55-70 mmHg
  • Required to have central venous access and an arterial line present, and these are expected to remain present for at least the initial 48 hours of study
  • Required to have an indwelling urinary catheter present, and it is expected to remain present for at least the initial 48 hours of study
  • Must have received at least 25 mL/kg of crystalloid or colloid equivalent over the previous 24-hour period, and be adequately volume resuscitated in the opinion of the treating investigator
  • Must have clinical features of high-output shock by meeting one of the following criteria
    • Central venous oxygen saturation (ScvO2) > 70% (either by oximetry catheter or by central venous blood gas) and central venous pressure (CVP) > 8 mmHg
    • Cardiac Index (CI) > 2.3 L/min/1.73 m2
  • Patient or legal surrogate is willing and able to provide written informed consent and comply with all protocol requirements

Exclusion Criteria

  • < 18 years of age
  • Has burns covering > 20% of total body surface area
  • Has a cardiovascular SOFA score ≤ 3
  • Diagnosed with acute occlusive coronary syndrome requiring intervention
  • On veno-arterial (VA) ECMO
  • Has been on ECMO for less than 12 hours
  • In liver failure with a Model for End-Stage Liver Disease (MELD) score of ≥ 30
  • History of asthma or currently experiencing bronchospasm requiring the use of inhaled bronchodilators, if not mechanically ventilated
  • Has acute mesenteric ischemia or a history of mesenteric ischemia
  • A history of, presence of, or highly-suspected of having an aortic dissection or abdominal aortic aneurysm
  • Requires more than 500 mg daily of hydrocortisone or equivalent glucocorticoid medication as a standing dose
  • Has Raynaud's phenomenon, systemic sclerosis or vasospastic disease
  • An expected lifespan of < 12 hours
  • Active bleeding AND an anticipated need (within 48 hours of initiation of the study) for transfusion of > 4 units of packed red blood cells
  • Active bleeding AND hemoglobin < 7g/dL or any other condition that would contraindicate serial blood sampling
  • An absolute neutrophil count (ANC) of < 1000 cells/mm3
  • A known allergy to mannitol
  • Currently participating in another interventional clinical trial
  • Known to be pregnant at the time of screening

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Ayan Sen, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
.

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