Catecholamine Resistant Hypotension (CRH)NCT03245528
Expanded Access for LJPC-501
A study testing LJPC-501 in people with Catecholamine Resistant Hypotension (CRH) and Distributive Shock, run by La Jolla Pharmaceutical Company.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catecholamine Resistant Hypotension (CRH), Distributive Shock, High Output Shock
- What is being tested?
- LJPC-501
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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.
Read the 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.
- Conditions
- Catecholamine Resistant Hypotension (CRH), Distributive Shock, High Output Shock, Sepsis, Vasodilatory Shock
- Being tested
- LJPC-501
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LJPC-501Drug
angiotensin II
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catecholamine Resistant Hypotension (CRH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- La Jolla Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245528
- Sponsor's protocol ID
- LJ501-EAP01
- Status last verified
- Mar 2018
- First submitted
- 7 Aug 2017
- Last updated
- 8 Mar 2018
- Results posted
- No