A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension (NCT02338843) | Clinical Trial Compass
CompletedPhase 3
A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension
United States, Australia, Belgium344 participantsStarted 2015-03
Plain-language summary
This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple centers globally.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult patients ≥ 18 years of age with CRH, defined as those who require a total sum catecholamine dose of \> 0.2 mcg/kg/min for a minimum of 6 hours and a maximum of 48 hours, to maintain a MAP between 55-70 mmHg.
. Patients are required to have central venous access and an arterial line present, and these are expected to remain present for at least the initial 48 hours of study.
. Patients are required to have an indwelling urinary catheter present, and it is expected to remain present for at least the initial 48 hours of study.
. Patients must have received at least 25 mL/kg of crystalloid or colloid equivalent over the previous 24-hour period, and be adequately volume resuscitated in the opinion of the treating investigator.
. Patients must have clinical features of high-output shock by meeting one of the following criteria.
. Central venous oxygen saturation (ScvO2) \> 70% (either by oximetry catheter or by central venous blood gas) and central venous pressure (CVP) \> 8 mmHg.
. Cardiac Index (CI) \> 2.3 L/min/1.73 m2. Patient must meet 5a or 5b to be eligible.
. Patient or legal surrogate is willing and able to provide written informed consent and comply with all protocol requirements.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
An Increased MAP, Defined as Achievement of a Day 1 MAP at 3 Hours Following the Initiation of Study Drug, of ≥ 75 mmHg OR a 10 mmHg Increase in Baseline MAP
. Any patient with burns covering \> 20% of total body surface area (TBSA).
. Patients with a Cardiovascular (CV) SOFA score ≤ 3.
. Patients diagnosed with acute occlusive coronary syndrome requiring intervention.
. Patients on veno-arterial (VA) ECMO.
. Patients who have been on ECMO for less than 12 hours.
. Patients in liver failure with a Model for End-Stage Liver Disease (MELD) score of ≥ 30.
. Patients with a history of asthma or who are currently experiencing bronchospasm requiring the use of inhaled bronchodilators, if not mechanically ventilated.