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-501, in pediatric patients who remain hypotensive despite receiving fluid therapy and vasopressor therapy. In addition, this study will evaluate the safety and tolerability of LJPC-501 in pediatric patients, the change in MAP over 24 hours after the start of LJPC-501, the change in serum lactate concentrations, and the change in Pediatric Logistic Organ Dysfunction (PELOD) scores.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Angiotensin II is a peptide hormone naturally produced by the body that regulates blood pressure via vasoconstriction and sodium reabsorption. LJPC-501 (angiotensin II) is being developed for the treatment of hypotension in patients who do not respond to fluids and vasopressor therapy.
Investigational Site
Charlotte, North Carolina, United States
Investigational Site
Cincinnati, Ohio, United States
Investigational Site
San Antonio, Texas, United States
Effect of LJPC-501 on mean arterial pressure (MAP)
To evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP).
Time frame: 2 hours
Effect of LJPC-501 on sum norepinephrine (NE) equivalent dose
To evaluate the effect of LJPC-501 in the reduction of the sum norepinephrine (NE) equivalent dosing.
Time frame: 2 hours
Effect of LJPC-501 on the incidence of treatment-emergent adverse events
Time frame: Day 7
Effect of LJPC-501 on mean arterial pressure (MAP)
To evaluate the change in MAP over 24 hours after the start of LJPC-501.
Time frame: 24 hours
Effect of LJPC-501 on serum lactate
To evaluate the change in serum lactate concentrations.
Time frame: 2 hours and 24 hours
Effect of LJPC-501 on Pediatric Logistic Organ Dysfunction (PELOD)
To evaluate change in Pediatric Logistic Organ Dysfunction (PELOD) score from Screening to 24 hours. The PELOD score is the sum of 6 individual item scores that totals 0-71 points. A higher PELOD score represents a worse outcome.
Time frame: 24 hours
Effect of LJPC-501 on clinical chemistry laboratory parameters
Safety data for clinical chemistry parameters including ALT, AST, ALP, total bilirubin, direct bilirubin, creatinine, BUN, phosphorus, glucose, albumin, calcium, bicarbonate, chloride, sodium, potassium, magnesium, PT, PTT, and INR. In addition, serum pregnancy test will be assessed at screening to confirm eligibility.
Time frame: 24 hours
Effect of LJPC-501 on hematology laboratory parameters
Safety data for laboratory hematology parameters including hemoglobin, hematocrit, platelets, and WBC.
Time frame: 24 hours
Effect of LJPC-501 on blood pressure
Change in blood pressure (mmHg).
Time frame: Day 7
Effect of LJPC-501 on heart rate
Change in heart rate (bpm).
Time frame: Day 7
Effect of LJPC-501 on body temperature
Change in body temperature (Celsius).
Time frame: Hour 24
Effect of LJPC-501 on general health
Change in physical examination (by body system).
Time frame: Day 7
Effect of LJPC-501 on electrical activity of the heart
Change in the electrical activity of the heart over a period of time using electrodes placed on the skin and recorded by electrocardiogram (ECG).
Time frame: Hour 24
Effect of LJPC-501 on urine output
Change in urine output (ml).
Time frame: Day 7
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