A Phase 2 interventional study of Angiotensin II in Catecholamine-resistant Hypotension (CRH), Distributive Shock and High Output Shock, sponsored by La Jolla Pharmaceutical Company. Completed at 3 sites in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-08-07.
Sponsored by La Jolla Pharmaceutical Company · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 517 studies in Sepsis with a site in United States — 75 open to participants now, 99 under way, 3 of them phase 3. Sepsis · United States.
Among the 517 studies in Sepsis with a site in United States, this one is the 293rd largest by enrollment of the 310 interventional ones that give a count, is one of 25 that started in 2018, is one of 50 in phase 2, and was the 290th registered.
2,417 studies on the registry are indexed under Sepsis; 542 are open to participants now.
Browse Sepsis studies →75 of the 517 studies in Sepsis with a site in United States are open now. Recruiting first, the newest first:
Deepull Diagnostics S.L. · Sites in United States, France, Germany and 2 more countries
Intermountain Health Care, Inc. · Sites in United States
Ages 18+
Bassett Healthcare · Sites in United States
Ages 18+
Duke University · Sites in United States
Ages 0 days–7 days
Vanderbilt University Medical Center · Sites in United States
Ages 1 days–12 mo
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 318 Sepsis studies recruiting now, 213 (67%) set no upper age limit and 53 (17%) stop at 75 or younger; 68 take children under 18; 42 take healthy volunteers.
This study: 2 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
517 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 50 · Phase 2 80 · Phase 3 47 · Phase 4 25
First in 1988; this study’s year is marked. 25 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2 is below the median of 102 across 1,166 interventional studies indexed under Sepsis.
Median enrollment 84 across the 310 interventional studies, 183 across the 204 observational. Of the 361 that completed or were terminated, 117 (32%) have results posted.
This tab as a report to print or save as PDF → With an account.
135 of 517 have an industry lead sponsor. The 10 most frequent:
La Jolla Pharmaceutical Company is the lead sponsor of 18 studies on the registry; none are open to participants now.
La Jolla Pharmaceutical Company has 3 studies filed under Sepsis — fewer than ten, so there is no comparison to draw.
36 of the studies in Sepsis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06817408Mayo ClinicDynamics of Organ Damage and Immune Exhaustion During Sepsis | 2026-12 |
| NCT04796285Brigham and Women's HospitalA Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor | 2026-12 |
| NCT01315782The University of Texas Health Science Center, HoustonAlveolar Dead Space as Predictor of Organ Failure in Severe Sepsis | 2026-12 |
| NCT06692400Loma Linda UniversityThe Effects of Endotracheal Suctioning on Pain and Serum Markers | 2026-12 |
| NCT03133208University of FloridaSepsis Associated Encephalopathy (SAE) Biomarkers | 2026-12-15 |
Add all 36 to your calendar (.ics) → With an account.
Among the 517 studies in Sepsis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Angiotensin II administered via continuous infusion (1.25 - 40 ng/kg/min) for 24 hours up to 168 hours.
Drug: Angiotensin II
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.
Also known as: Giapreza
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
Ran from Feb 2018 to primary completion in Apr 2018, 2 months.
Of 60 phase 2 interventional studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 37. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Angiotensin II
La Jolla Pharmaceutical Company