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
About this trial
This is an expanded access trial for Catecholamine Resistant Hypotension (CRH)
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT03245528
First Posted
August 7, 2017
Last Updated
March 6, 2018
Sponsor
La Jolla Pharmaceutical Company
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
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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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