NCT06351150招募中3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Angiotensin II Injection in the Background Treatment of Catecholamines and Other Vasopressors in Chinese Adult Patients With Refractory Distributive Shock
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 214
- 试验地点
- 42
- 主要终点
- Proportion of subjects with blood pressure response at 3 hours after administration of study drug
研究概览
简要总结
A randomized, double-blind, placebo-controlled study on the treatment of refractory distributed shock with angiotensin II injection, with a random ratio of 1:1. Assuming a success rate of 25% for the main therapeutic endpoint in the control group and 50% for the experimental group, a total of 214 subjects will be enrolled, including 107 in the experimental group and 107 in the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 18 years to 75 years old, male or female;
- •diagnosis of distributive shock;
- •on the basis of the treatment of total vasoactive drugs dose > 0.2 μg/kg/min norepinephrine (or equivalent dose of another vasoactive drug: such as epinephrine > 0.2 μg/kg/min, dopamine > 30 μg/kg/min, phenylephrine > 2 μg/kg/min, vasopressin > 0.08 U/min) and continuous treatment for at least 6 hours and no more than 48 hours, the patient's mean arterial pressure can still only be maintained between 55 and 70 mmHg, or do not reach the target MAP assessed by clinicians, it can be diagnosed as refractory distributive shock.
- •have central venous access and arterial catheters, and are expected to be present for at least the first 48 hours of the study.
- •indwelling catheter, and expected to be present for at least the first 48 hours of the study.
- •patient has received at least 30 mL/kg of crystalloid or colloid volume in the previous 24 hours or has undergone adequate volume resuscitation in the opinion of the investigator.
- •patients must have one of the following criteria with clinical features of high-output shock
- •Central venous oxygen saturation (ScVO2) > 70% (via saturation catheter or central venous blood gas) and central venous pressure (CVP) > 8 mmHg.
- •cardiac index (CI) > 2.3 L/min/m
- •the patient or legal representative is willing and able to provide written informed consent and comply with all protocol requirements.
排除标准
- •Patients with burns > 20% of total body surface area;
- •Patients with cardiovascular (CV) SOFA score ≤ 3;
- •Patients with acute coronary syndrome requiring interventional therapy;
- •Patients treated with Extracorporeal Membrane Oxygenation (ECMO);
- •Patients with end-stage liver failure (Model for end-stage liver disease score (MELD) > 30).
- •Patients with a diagnosis of asthma or bronchospasm.
- •Patients with a diagnosis of acute mesenteric ischemia, or patients with suspected acute mesenteric ischemia.
- •Patients with a history, presence, or high suspicion of aortic dissection or abdominal aortic aneurysm, or patients diagnosed with aortic dissection or abdominal aortic aneurysm.
- •Patients who have been diagnosed with malignant tumor within the past 2 years, except for early malignant tumors (carcinoma in situ or stage I tumor) that have been radically treated or expected to recover after treatment, such as adequately treated thyroid cancer, cervical carcinoma in situ, basal cell or squamous cell carcinoma.
- •Patients with Raynaud's phenomenon, systemic sclerosis or vasospastic disease.
- •Patients with life expectancy ≤ 24 hours as assessed by the study physician.
- •Patients with active bleeding who are expected to require transfusion of > 4 units of packed red blood cells within 48 hours of study start.
- •Patients with active bleeding and hemoglobin < 7 g/dL or any other condition that contraindicates serial blood sampling.
- •Patients with absolute neutrophil count (ANC) < 1000 cells/mm
- •Patients with known hypersensitivity to angiotensin II injection and its excipients.
- •Patients who are currently participating in another interventional clinical trial.
- •Blood/urine pregnancy test should be performed for patients with known pregnancy at screening and those with clinical suspicion of pregnancy.
- •Patients who are considered unstable by the investigator or have any condition that would affect the safety of the study or the interpretation of the study results, or that would prevent the patient from completing the study, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical disorders. For example: patients with arrhythmia, uncontrolled hyperglycemia, cerebrovascular disease, uncontrolled hypertension, autoimmune disease requiring daily use of ≥ 500 mg hydrocortisone or equivalent glucocorticoids, etc.
研究组 & 干预措施
Placebo
Placebo Comparator
The placebo is administered via central vein, and the drug dosage is adjusted according to MAP, with an allowable dose of 1.25~160 ng/kg/min. Maximum 168 h.
干预措施: 0.9% sodium chloride injection (Drug)
Angiotensin Ⅱ Injection
Experimental
Angiotensin II injection is administered via central vein, and the drug dosage is adjusted according to Mean Arterial Pressure (MAP), with an allowable dose of 1.25~160 ng/kg/min. Maximum 168 h.
干预措施: Angiotensin II Injection (Drug)
结局指标
主要结局
Proportion of subjects with blood pressure response at 3 hours after administration of study drug
时间窗: 3 hours after dose
Defined as MAP ≥ 75 mmHg or MAP increase ≥ 10 mmHg from baseline compared to baseline without an increase in the dose of background vasoactive agents
次要结局
- Sequential Organ Failure Assessment (SOFA) total score(48 hours after dose)
- Cardiovascular SOFA subscore(48 hours after dose)
- Mortality at Day 7(Day 7 after dose)
- Mortality at Day 28(Day 28 after dose)
- Proportion of subjects with blood pressure response at 1 hour after administration(1 hour after dose)
- Proportion of subjects with blood pressure response at 2 hours after administration(2 hours after dose)
- Change in background vasoactive agent dose from 0 to 48 hours(48 hours after dose)
- Absolute change in blood lactate from 0 to 3 hours(3 hours after dose)
- Absolute change in blood lactate from 3 to 48 hours(3 to 48 hours after dose)
- Absolute change in heart rate from 0 to 3 hours(3 hours after dose)
- Absolute change in heart rate from 3 to 48 hours(3 to 48 hours after dose)
- Adverse events (AE)(From drug administration to the end of the study, a total of 28 days)
- Serious adverse events (SAE)(From drug administration to the end of the study, a total of 28 days)
研究者
研究点 (42)
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