An Open-Label, Single-Center Study of Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension Despite Receiving Fluid Therapy and Vasoactive Therapy
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage of patients who have improvement in mean arterial pressure or reduction in sum norepinephrine equivalent at Hour 2 after the start of Synthetic Angiotensin-II
研究概览
简要总结
The goal of this clinical trial is to determine the safety and efficacy of Angiotensin-II in the treatment of pediatric patients in fluid refractory vasodilatory shock. The main questions it aims to answer are:
-
To evaluate the change in blood pressure or reduction of vasoactive requirements (norepinephrine equivalent dosing) after initiating Angiotensin II
-
To establish the safety and tolerability of Angiotensin-II in pediatric patients Participants will receive Angiotensin-II in addition to standard of care therapy for vasodilatory shock.
-
The study team will then monitor the patient's vital signs, blood work, and for any potential side effects from the drug.
-
An ultrasound will be performed to look at blood flow through the kidney in the setting of vasodilatory shock.
-
A follow up phone call to check in with the patient will be performed 28 days after enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients less than 18 years of age who have received at least 40 mL/kg of crystalloid or colloid equivalent fluid resuscitation for vasodilatory shock
- •Titration of standard of care vasoactive medications for a minimum of 2 hours with persistent refractory hypotension for age, and who require a total sum NE equivalent dose of > 0.1 μg/kg/min for a minimum of 1 hours and a maximum of 24 hours prior to initiation of Angiotensin-II.
- •Indwelling arterial and central venous lines.
- •Parent or legal guardian is willing and able to provide informed consent and assist the patient in complying with all protocol requirements.
排除标准
- •Standing DNR/DNI order
- •Alternative shock diagnosis i.e. cardiogenic shock or post cardiac surgery
- •Cannulated to extracorporeal membrane oxygenation
- •Pre-existing condition confounding outcome determination such as terminal illness
- •Patients diagnosed with acute occlusive coronary syndrome requiring pending intervention.
- •Patients who have a history of asthma or are currently experiencing bronchospasm requiring the use of inhaled bronchodilators and who are not mechanically ventilated.
- •Patients with acute mesenteric ischemia or a history of mesenteric ischemia.
- •Patients with active bleeding AND an anticipated need of multiple transfusions (within 48 hours of Screening).
- •Patients with active bleeding, hemoglobin < 7 g/dL, or any other condition that would contraindicate serial blood sampling.
- •Patients requiring more than 5 mg/kg daily of hydrocortisone or equivalent glucocorticoid medication as a standing dose.
- •Patients with an expected lifespan of < 12 hours or withdrawal of life support within 24 hours of screening.
- •Patients currently using an angiotensin converting enzyme inhibitor or angiotensin receptor blocker.
- •Patients with a known allergy to mannitol.
- •Patients who are currently participating in another investigational clinical trial.
- •Patients of childbearing potential who are known to be pregnant at the time of screening.
- •Prisoners
- •Patient's with Raynaud phenomenon, systemic sclerosis, or vasospastic disease.
研究组 & 干预措施
Pediatric patients in vasodilatory shock
Patients enrolled in the study who meet inclusion criteria will receive Angiotensin-II per the titration protocol.
干预措施: Angiotensin-II (Drug)
结局指标
主要结局
Percentage of patients who have improvement in mean arterial pressure or reduction in sum norepinephrine equivalent at Hour 2 after the start of Synthetic Angiotensin-II
时间窗: From enrollment to Hour 2
Percentage (%) of patients who have improvement in mean arterial pressure (MAP, mmHg) or reduction in sum norepinephrine (NE) equivalent at Hour 2 after the start of Synthetic Angiotensin-II
次要结局
- Change in MAP(From enrollment to 24 hours)
- Change in systolic blood pressure(From enrollment to 24 hours)
- Change in diastolic blood pressure(From enrollment to 24 hours)
- Change in concentration of serum lactate(From enrollment to 24 hours)
- Change in pSOFA score(From enrollment to 24 hours)
- Change in PRSIM-III score(From enrollment to 24 hours)
- Change in total neutrophil count(From enrollment to 24 hours)
- Change in renal resistive index (%)(From enrollment to 24 hours)
研究者
Todd Sweberg
MD
Northwell Health