A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension

Completed · Phase 3 · Has a placebo group

Conditions studied: Catecholamine-resistant Hypotension (CRH), Distributive Shock, High Output Shock, Sepsis

In brief

This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple centers globally.

Key facts

Study ID

NCT02338843

Run by

La Jolla Pharmaceutical Company

People needed

344

Starts

2015-03-01

Expected to finish

2017-02-18

Last updated by the study team

2018-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients ≥ 18 years of age with CRH, defined as those who require 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.
• Patients are 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.
• Patients are required to have an indwelling urinary catheter present, and it is expected to remain present for at least the initial 48 hours of study.
• Patients 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.
• Patients 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.
• OR
• Cardiac Index (CI) > 2.3 L/min/1.73 m2. Patient must meet 5a or 5b to be eligible.
• Patient or legal surrogate is willing and able to provide written informed consent and comply with all protocol requirements.

You may not qualify if…

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

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Keck Hospital of USC — Los Angeles, California, United States
• Los Angeles County + University of Southern California Medical Center — Los Angeles, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• University of California, Irvine Medical Center — Orange, California, United States
• University of California, Davis — Sacramento, California, United States
• University of Florida — Gainesville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Joseph M. Still Research Foundation, Inc. — Augusta, Georgia, United States
• Eastern Idaho Regional Medical Center — Idaho Falls, Idaho, United States
• Northwestern University — Chicago, Illinois, United States
• Methodist Hospital, Indiana University Health Physicians — Indianapolis, Indiana, United States
• Kentucky Lung Clinic — Hazard, Kentucky, United States
• University of Louisville — Louisville, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• St. Paul Regions Hospital — Saint Paul, Minnesota, United States
• Saint Louis University — St Louis, Missouri, United States
• Pulmonary Associates of Mobile, PC — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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