Status:
APPROVED_FOR_MARKETING
Expanded Access for LJPC-501
Lead Sponsor:
La Jolla Pharmaceutical Company
Conditions:
Catecholamine Resistant Hypotension (CRH)
Distributive Shock
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.
Detailed Description
Primary Objective The primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy. Secondar...
Eligibility Criteria
Inclusion
- Patients must be adults ≥ 18 years of age who remain hypotensive despite fluid therapy and vasopressor therapy and who received or are receiving a total sum norepinephrine (NE) equivalent unit dose of \> 0.2 µg/kg/min for at least 2 hours prior to LJPC-501 infusion.
- Patients must have central venous access and an arterial line present, which is expected to remain for the duration of the LJPC-501 infusion.
- Patients must be adequately volume resuscitated in the opinion of the treating investigator.
- Patients must have clinical features of distributive shock documented by either estimated or measured CI \> 2.3 L/min/m\^2 determined by echocardiogram or another cardiac output monitoring modality OR a concurrent CVP \> 8 mmHg and ScvO2 \> 70%.
- Patient or legal surrogate is willing and able to provide informed consent per local guidance and patient/legal surrogate is willing to comply with all protocol requirements.
Exclusion
- Patients with a MAP \> 80 mmHg.
- Patients diagnosed with acute occlusive coronary syndrome requiring intervention.
- Patients who have been on ECMO \< 6 hours.
- Patients in liver failure with a MELD score ≥ 30.
- Patients not mechanically ventilated with a history of asthma or who are currently experiencing bronchospasm requiring the use of inhaled bronchodilators.
- Patients with acute mesenteric ischemic or history of mesenteric ischemia.
- Patients with Raynaud's phenomenon, systemic sclerosis, or vasospastic disease.
- Patients with an expected lifespan of \< 24 hours.
- Patients with active bleeding AND an anticipated need for transfusion of \> 4 units PRBCs within 48 hours of the initiation of LJPC-501.
- Patients with active bleeding AND hemoglobin \< 7 g/dL.
- Patients with an ANC \< 500 cells/mm\^3.
- Patients with a known allergy to mannitol.
- Patients who are currently participating in an investigational interventional trial.
- Women who are known to be pregnant at the time of Screening or have a positive serum or urine β-hCG, if of childbearing potential.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03245528
Last Update
March 8 2018
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