NCT03245528Approved For Marketing不适用
Expanded Access for LJPC-501
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
研究概览
简要总结
The primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.
详细描述
Primary Objective
The primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.
Secondary Objective
The secondary objective of the study is to assess the safety of LJPC-501.
研究设计
- 研究类型
- Expanded Access
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
- •Patients must be adults ≥ 18 years of age who remain hypotensive despite fluid therapy and vasopressor therapy and who received or are receiving a total sum norepinephrine (NE) equivalent unit dose of > 0.2 µg/kg/min for at least 2 hours prior to LJPC-501 infusion.
- •Patients must have central venous access and an arterial line present, which is expected to remain for the duration of the LJPC-501 infusion.
- •Patients must be adequately volume resuscitated in the opinion of the treating investigator.
- •Patients must have clinical features of distributive shock documented by either estimated or measured CI > 2.3 L/min/m^2 determined by echocardiogram or another cardiac output monitoring modality OR a concurrent CVP > 8 mmHg and ScvO2 > 70%.
- •Patient or legal surrogate is willing and able to provide informed consent per local guidance and patient/legal surrogate is willing to comply with all protocol requirements.
排除标准
- •Patients with a MAP > 80 mmHg.
- •Patients diagnosed with acute occlusive coronary syndrome requiring intervention.
- •Patients who have been on ECMO < 6 hours.
- •Patients in liver failure with a MELD score ≥
- •Patients not mechanically ventilated with a history of asthma or who are currently experiencing bronchospasm requiring the use of inhaled bronchodilators.
- •Patients with acute mesenteric ischemic or history of mesenteric ischemia.
- •Patients with Raynaud's phenomenon, systemic sclerosis, or vasospastic disease.
- •Patients with an expected lifespan of < 24 hours.
- •Patients with active bleeding AND an anticipated need for transfusion of > 4 units PRBCs within 48 hours of the initiation of LJPC-
- •Patients with active bleeding AND hemoglobin < 7 g/dL.
- •Patients with an ANC < 500 cells/mm^
- •Patients with a known allergy to mannitol.
- •Patients who are currently participating in an investigational interventional trial.
- •Women who are known to be pregnant at the time of Screening or have a positive serum or urine β-hCG, if of childbearing potential.
研究者
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