Catecholamine-resistant hypotension associated with distributive shock
Conditions
Interventions
Product Name: GiaprezaTM
Product Code: LJPC-501
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Angiotensin II acetate
Sponsors
La Jolla Pharmaceutical Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Paediatric patients > 2 years (ie, > 24 months) to 0.1 µg/kg/min to maintain ageappropriate target MAP for a minimum of 2 hours and a maximum of 48 hours prior to initiation of study drug. 3. Patients must have a clinical diagnosis of distributive shock in the opinion of the treating team and the Investigator. 4. Patients are required to have central venous access, which is expected to remain present for the duration of study drug treatment. 5. 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. 6. 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. 7. Parent(s) or legal guardian(s) is willing and able to provide informed consent and assist the patient in complying with all protocol requirements. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Patients who are = 2 years (24 months) of age or = 18 years of age at enrolment. 2. Patients with a standing Do Not Resuscitate order. 3. Patients diagnosed with acute occlusive coronary syndrome requiring pending intervention. 4. Patients on veno-arterial (VA) extracorporeal membrane oxygenation (ECMO). 5. Patients who have been on veno-venous (VV) ECMO for less than 6 hours. 6. Patients with a clinical suspicion of cardiogenic shock based on echocardiogram. 7. Patients who have a history of asthma or are currently experiencing bronchospasm requiring the use of inhaled bronchodilators and who are not mechanically ventilated. 8. Patients with acute mesenteric ischaemia or a history of mesenteric ischaemia. 9. Patients with active bleeding AND an anticipated need of multiple transfusions (within 48 hours of Screening). 10. Patients with active bleeding AND haemoglobin < 7 g/dL. 11. Patients with an expected lifespan of < 12 hours or expected withdrawal of life support within 24 hours of Screening. 12. Patients with a known allergy to mannitol. 13. 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. 14. Patients of childbearing potential who are known to be pregnant at the time of Screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) as assessed by standard of care vasopressor dose reduction in paediatric patients with catecholamine-resistant hypotension (CRH); Secondary Objective: • To evaluate change in the Paediatric Logistic Organ Dysfunction-2 (PELOD-2) score • To establish the safety and tolerability of LJPC-501 in paediatric patients with CRH • To evaluate changes in catecholamine and other vasopressor doses over time • To evaluate the change in MAP over time ;Primary end point(s): • Proportion of patients who have achieved = 50% reduction in vasopressor dose as measured by NED from baseline to Hour 3;Timepoint(s) of evaluation of this end point: • 3h post baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in PELOD-2 score from baseline to Hour 24 and Hour 48 • Change in catecholamine and other vasopressor doses from baseline to Hour 24 and Hour 48 • Change in MAP from baseline to Hour 3, Hour 24, and Hour 48 • Change in heart rate from baseline to Hour 3, Hour 24, and Hour 48 ;Timepoint(s) of evaluation of this end point: 3h, 24h and 48h post baseline | — |
Countries
Belgium, Estonia, France, Lithuania, Spain, United Kingdom
Contacts
Public ContactRena Harrigan
La Jolla Pharmaceutical Company
Outcome results
None listed