A Study of LJPC-501 in Paediatric Patients With Hypotension Associated With Distributive or Vasodilatory Shock

  • End date
    Apr 22, 2023
  • participants needed
  • sponsor
    La Jolla Pharmaceutical Company
Updated on 12 February 2022
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The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) as assessed by standard of care vasopressor dose reduction in pediatric patients with catecholamine-resistant hypotension (CRH). In addition, this study will evaluate the safety and tolerability of LJPC-501 in pediatric patients, evaluate changes in catecholamine and other vasopressor doses over time, evaluate the change in MAP over time, and the change in Pediatric Logistic Organ Dysfunction-2 (PELOD-2) scores.

Condition Catecholamine-resistant Hypotension (CRH), Distributive Shock, High Output Shock, Septic Shock
Treatment Placebo, LJPC-501 (angiotensin II)
Clinical Study IdentifierNCT03623529
SponsorLa Jolla Pharmaceutical Company
Last Modified on12 February 2022


Yes No Not Sure

Inclusion Criteria

Male and female paediatric patients with catecholamine-resistant hypotension
associated with distributive shock
Paediatric patients > 2 years (ie, > 24 months) to < 18 years of age at enrolment
Patients requiring a sum norepinephrine-equivalent dose > 0.1 g/kg/min to maintain age-appropriate target MAP for a minimum of 2 hours and a maximum of 48 hours prior to initiation of study drug
Patients must have a 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 study drug treatment
Patients are required to have an indwelling arterial line, which is expected to remain present for at least the first 48 hours of study drug treatment
Patients must have received at least 40 mL/kg of crystalloid or colloid equivalent over the initial 24-hour resuscitation period, and must be adequately volume resuscitated in the opinion of the Investigator, prior to starting study drug
Parent(s) or legal guardian(s) is willing and able to provide informed consent and assist the patient in complying with all protocol requirements

Exclusion Criteria

Patients who are 2 years (24 months) of age or 18 years of age at enrolment
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 based on echocardiogram
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 ischaemia or a history of mesenteric ischaemia
Patients with active bleeding AND an anticipated need of multiple transfusions (within 48 hours of Screening)
Patients with active bleeding AND haemoglobin < 7 g/dL
Patients with an expected lifespan of < 12 hours or expected withdrawal of life support within 24 hours of Screening
Patients with a known allergy to mannitol
Patients who are currently participating in another clinical trial using an investigational drug not approved in that member country unless specifically approved by the Sponsor
Patients of childbearing potential who are known to be pregnant at the time of Screening
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