Distributive shock
Conditions
Interventions
Angiotensin ? Group:Phase 1 Dosing Regimen: 0-3 hours after initiation of the investigational product
The primary endpoint for this phase is the proportion of subjects achieving MAP >= 75 mmHg at hour
Sponsors
The First Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and 0.2 µg/kg/min of norepinephrine (or an equivalent dose of another vasopressor: e.g., norepinephrine bitartrate >0.4 µg/kg/min, epinephrine >0.2 µg/kg/min, dopamine >30 µg/kg/min, or phenylephrine >2 µg/kg/min) for at least 3 hours but no more than 48 hours, the patient's mean arterial pressure (MAP) remains between 55–70 mmHg or fails to reach the clinician-assessed target MAP; 4. Presence of central venous access and an arterial catheter, with an expectation that these access routes will remain in place for at least the first 48 hours of the study; 5. Presence of an indwelling urinary catheter, with an expectation that it will remain in place for at least the first 48 hours of the study; 6. The patient has received at least 30 mL/kg of crystalloid or colloid fluid within the past 24 hours, or, in the opinion of the treating investigator, has undergone adequate volume resuscitation; 7. The patient must meet at least one of the following criteria, demonstrating clinical features of high-output shock: a. Central venous oxygen saturation (ScvO2) >70% (monitored via oximetry catheter or central venous blood gas) and central venous pressure (CVP) >8 mmHg; b. Cardiac index (CI) >2.3 L/min/m² (monitored via echocardiography, pulse wave analysis, or thermodilution/transpulmonary thermodilution); 8. The subject or their legal guardian has fully understood the purpose and significance of this trial, voluntarily agrees to participate in this clinical study, and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Known or suspected allergy or contraindication to Angiotensin II injection or its excipients; 2) Patients with burns covering >20% of total body surface area; 3) Patients with acute coronary syndrome requiring interventional therapy; 4) Patients receiving extracorporeal membrane oxygenation (ECMO) therapy; 5) Patients with end-stage liver failure (Model for End-Stage Liver Disease [MELD] score >30); 6) Patients diagnosed with asthma or bronchospasm; 7) Patients diagnosed with acute mesenteric ischemia or suspected acute mesenteric ischemia; 8) Patients with a history or current diagnosis of aortic dissection or abdominal aortic aneurysm, or those highly suspected of having aortic dissection or abdominal aortic aneurysm; 9) Patients with Raynaud’s phenomenon, systemic sclerosis, or vasospastic disorders; 10) Patients assessed by the investigator to have an expected survival of 4 units of packed red blood cells within 48 hours before study drug administration; 12) Patients with active bleeding and hemoglobin = 500 mg hydrocortisone or equivalent glucocorticoids; 16) Patients who participated in another drug or medical device clinical trial within 1 month before enrollment; 17) Pregnant and/or breastfeeding women; 18) Patients deemed by the investigator to be clinically unstable or to have any pre-existing condition that may affect safety during the study, compromise the interpretation of study results, or prevent completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving blood pressure response at 3 hours after administration of the investigational product; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Sequential Organ Failure Assessment (SOFA) total score from baseline at 48 hours;All-cause mortality rate of subjects at day 7;;All-cause mortality rate of subjects at day 28;Change in cardiovascular SOFA subscore from baseline at 48 hours;Proportion of subjects achieving blood pressure response at 1 hour after investigational product administration;Proportion of subjects achieving blood pressure response at 2 hour after investigational product administration;Change in background vasoactive agent dose during 3-48 hours;Absolute change in blood lactate levels during 0-3 hours and 3-48 hours;Absolute change in heart rate during 0-3 hours and 3-48 hours; | — |
Countries
China
Contacts
Public ContactRui Shi
The First Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed