Status:
COMPLETED
A Study of LJPC-501 in Pediatric Patients With Hypotension
Lead Sponsor:
La Jolla Pharmaceutical Company
Conditions:
Catecholamine-resistant Hypotension (CRH)
Distributive Shock
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) or reduction in sum norepinephrine (NE) equivalent dosing, at Hour 2 after the start of LJPC-...
Eligibility Criteria
Inclusion
- Pediatric patients 2-17 years of age.
- Patients requiring a total sum NE equivalent dose of \> 0.1 μg/kg/min for a minimum of 2 hours and a maximum of 48 hours prior to initiation of LJPC-501 dosing.
- Patients must have clinical diagnosis of distributive shock in the opinion of the treating team and the Investigator.
- Patients are required to have central venous access, which is expected to remain present for the duration of LJPC-501 treatment.
- Patients are required to have an indwelling arterial line, which is expected to remain present for at least the first 24 hours of LJPC-501 treatment.
- Patients must have received at least 40 mL/kg of crystalloid or colloid equivalent over the initial 24-hour resuscitation period, and are adequately volume resuscitated in the opinion of the Investigator.
- Parent or legal guardian is willing and able to provide informed consent and assist the patient in complying with all protocol requirements.
Exclusion
- Patients who are \< 2 years of age or ≥ 18 years of age.
- Patients with a standing Do Not Resuscitate order.
- Patients diagnosed with acute occlusive coronary syndrome requiring pending intervention.
- Patients on veno-arterial (VA) extracorporeal membrane oxygenation (ECMO).
- Patients who have been on veno-venous (VV) ECMO for less than 6 hours.
- Patients with a clinical suspicion of cardiogenic shock.
- Patients who have a history of asthma or are currently experiencing bronchospasm requiring the use of inhaled bronchodilators and who are not mechanically ventilated.
- Patients with acute mesenteric ischemia or a history of mesenteric ischemia.
- Patients with active bleeding AND an anticipated need of multiple transfusions (within 48 hours of Screening).
- Patients with active bleeding AND hemoglobin \< 7 g/dL or any other condition that would contraindicate serial blood sampling.
- Patients with an absolute neutrophil count (ANC) of \< 500 cells/mm3.
- Patients requiring more than 5 mg/kg daily of hydrocortisone or equivalent glucocorticoid medication as a standing dose.
- Patients with an expected lifespan of \< 12 hours or withdrawal of life support within 24 hours of Screening.
- Patients with a known allergy to mannitol.
- Patients who are currently participating in another investigational clinical trial.
- Patients of childbearing potential who are known to be pregnant at the time of Screening.
Key Trial Info
Start Date :
February 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2018
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03431077
Start Date
February 11 2018
End Date
April 14 2018
Last Update
August 7 2018
Active Locations (3)
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1
Investigational Site
Charlotte, North Carolina, United States, 28203
2
Investigational Site
Cincinnati, Ohio, United States, 45229
3
Investigational Site
San Antonio, Texas, United States, 78207