Expanded Access for LJPC-501

Study Overview
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Brief Summary
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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
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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. Secondary Objective The secondary objective of the study is to assess the safety of LJPC-501.

Official Title
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Expanded Access for LJPC-501

Conditions
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Sepsis, Catecholamine Resistant Hypotension (CRH), Distributive Shock, High Output Shock, Vasodilatory Shock

Intervention / Treatment
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* Drug: LJPC-501


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LJPC-501|angiotensin II|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |