Phase 3
N=321
A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension
Catecholamine-resistant Hypotension (CRH) · Distributive Shock · High Output Shock · Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT02338843 ↗Enrolled (actual)
321
Serious AEs
63.9%
Results posted
Jan 2018
Primary outcome: Primary: An Increased MAP, Defined as Achievement of a Day 1 MAP at 3 Hours Following the Initiation of Study Drug, of ≥ 75 mmHg OR a 10 mmHg Increase in Baseline MAP — 114; 37 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LJPC-501 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- La Jolla Pharmaceutical Company
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY An Increased MAP, Defined as Achievement of a Day 1 MAP at 3 Hours Following the Initiation of Study Drug, of ≥ 75 mmHg OR a 10 mmHg Increase in Baseline MAP |
114; 37 | <0.001 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Patients who are 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 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.
Data sourced from ClinicalTrials.gov (NCT02338843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.