Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Standing Dose of Norepinephrine Which is Required to Maintain a MAP of 65 mmHg - Hour 2
研究概览
简要总结
The investigators propose a dose finding study to determine the feasibility of Angiotensin II (AII) to increase mean arterial pressure in high-output shock. If AII can be shown to increase mean arterial pressure, this could lead to future pharmacologic development based on the AII hormonal pathway. The investigators propose a 20 patient, randomized, placebo-controlled, blinded study in the treatment of high-output shock. Patients with high-output shock and a cardiovascular SOFA (sequential organ failure score) score of > 4 will be eligible. In addition, patients must already be receiving cardiac output monitoring and have a cardiac index > 2.4 L/min/ 1.73 m2. Patients will be randomized to intravenous AII or saline in a blinded fashion. There will be 10 patients in each arm. This is a safety and dose finding feasibility study. The investigators are starting with a small cohort consistent with similar types of studies. The investigators estimate that ten patients in each arm will generate a basis for determining if there is sufficient signal for AII to improve blood pressure at the doses outlined. The primary endpoint in the study will be the effect of AII on the standing dose of norepinephrine which is required to maintain a mean arterial pressure (MAP) of 65 mmHg. Secondary endpoints will be the effect of AII on urine output, serum lactate, and creatinine clearance. 30 day post dose mortality will also be assessed. Subjects discharged prior to day 30 will be contacted by telephone for this assessment.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High-output shock
- •Cardiovascular SOFA score of > 4
- •Cardiac Index > 2.4 liters/min/BSA 1.73m2
- •Indwelling arterial line already present as part of standard care
- •Age > 21 years of age
- •Signed consent form
- •Use of indwelling urinary catheter as standard care expected at least for 12 hours during the study interventions
排除标准
- •Patients with acute coronary syndrome
- •Patients with a known history of vasospasm
- •Patients with a history of asthma
- •Patients currently experiencing bronchospasm
- •Patients with active bleeding with an anticipated need for > 4 units of PRBC or Hemoglobin < 7g/dL or any other condition that would contraindicate drawing serial blood samples
研究组 & 干预措施
Angiotensin
The angiotensin arm will receive angiotensin II acetate at an initial dose of 20ng/kg/min, titratable during the study (6 hours) for mean arterial pressure (MAP) goals as outlined in the protocol.
干预措施: Angiotensin II (Drug)
Control
Control patients will receive placebo intravenously equal in duration, color and volume to the intervention arm's angiotensin II.
干预措施: Angiotensin II (Drug)
结局指标
主要结局
Standing Dose of Norepinephrine Which is Required to Maintain a MAP of 65 mmHg - Hour 2
时间窗: 2 hours after initiation of ATII
The primary endpoint in the study will be the effect of AII on the standing dose of norepinephrine which is required to maintain a MAP of 65 mmHg.
Standing Dose of Norepinephrine Which is Required to Maintain a Mean Arterial Pressure (MAP) of 65 mmHg - Hour 1
时间窗: 1 hour after initiation of angiotensin II (ATII)
The primary endpoint in the study will be the effect of AII on the standing dose of norepinephrine which is required to maintain a mean arterial pressure (MAP) of 65 mmHg.
次要结局
- Mortality(30 days)