Catecholamine Resistant Hypotension (CRH), Distributive Shock, High Output Shock, Sepsis, Vasodilatory Shock
Conditions
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. Secondary Objective The secondary objective of the study is to assess the safety of LJPC-501.
Interventions
DRUGLJPC-501
angiotensin II
Sponsors
La Jolla Pharmaceutical Company
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Outcome results
None listed