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Expanded Access for LJPC-501

Primary Purpose

Catecholamine Resistant Hypotension (CRH), Distributive Shock, High Output Shock

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
LJPC-501
Sponsored by
La Jolla Pharmaceutical Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Catecholamine Resistant Hypotension (CRH)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 7, 2017
    Last Updated
    March 6, 2018
    Sponsor
    La Jolla Pharmaceutical Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03245528
    Brief Title
    Expanded Access for LJPC-501
    Official Title
    Expanded Access for LJPC-501
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Approved for marketing
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    La Jolla Pharmaceutical Company

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Catecholamine Resistant Hypotension (CRH), Distributive Shock, High Output Shock, Sepsis, Vasodilatory Shock

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    LJPC-501
    Intervention Description
    angiotensin II

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Access for LJPC-501

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