Sepsis-Induced Hypotension
Conditions
Keywords
Natriuretic Peptide Receptor 1 (NPR1), Low Blood Pressure
Brief summary
This study is researching an experimental drug called REGN7544 (called "study drug"). The study is focused on adult patients (18 to 85 years) hospitalized due to a serious infection (called "sepsis") and receiving standard-of-care medications for low blood pressure (called "vasopressors") due to sepsis. The aim of the study is to see how safe, tolerable, and effective the study drug is by observing the effects on blood pressure and the total amount of vasopressor dose received during the stay in the hospital. The study is looking at several other research questions, including: * How the study drug changes the blood pressure and the amount of intravenous (IV) fluids given to participants with low blood pressure due to sepsis * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Proven or suspected infection defined as administration or planned administration of antimicrobial therapy within the screening period 2. Sepsis-induced hypotension that has not responded to Intravenous (IV) fluids, receiving 1 or 2 vasopressors and maintaining a Mean Arterial Pressure (MAP) of ≥ 65 mm Hg for at least 2 consecutive hours immediately prior to randomization, as defined in the protocol Key
Exclusion criteria
1. Unable to obtain informed consent by participant or Legally Authorized Representative (LAR) 2. Clinical status requires vasopressor and/or Blood Pressure (BP) management inconsistent with the study protocol 3. Primary cause of hypotension suspected to be due to non-sepsis cause (eg, hemorrhage, burns, or cardiogenic shock), including shock after cardiac arrest 4. Ejection fraction \<20% in the most recent known echocardiogram 5. Acute coronary syndrome based on clinical symptoms and/or electrocardiogram (ECG) during hospitalization 6. History of hospitalization due to heart failure, myocardial infarction, stroke, clinically significant ventricular arrhythmia, transient ischemic attack, or unstable angina within the preceding 3 months 7. Any prior diagnosis of severe pulmonary hypertension, as defined in the protocol 8. Receiving 3 or more vasopressors or exceeding the maximal combined dose as defined in the protocol, during the screening period or at the time of study drug administration 9. Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia NOTE: Other Protocol-Defined Inclusion-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative vasopressor dose | Through 72 Hours |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 and higher Treatment-Emergent Adverse Events (TEAEs) | Through 90 Days |
| Time-weighted average Mean Arterial Pressure (MAP) | Baseline Over 4 Hours |
| Change in MAP | Baseline, At 4 Hours |
| Proportion of surviving participants free of vasopressor(s) | At 24, 48 and 72 Hours |
| Cumulative net fluid balance | Through 72 Hours |
| Cumulative urine output | Through 72 Hours |
| Cumulative fluid intake | Through 72 Hours |
| Concentrations of REGN7544 in serum | Through 90 Days |
| Incidence of Anti-Drug Antibodies (ADA) to REGN7544 | Through 90 Days |
| Magnitude of ADA to REGN7544 | Through 90 Days |
Countries
France, United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed