DRKS00000181进行中（未招募）3 期
A Phase III, Multicenter, Randomized, Placebo-Controlled Study of PHP When Administered by Continuous Infusion in Patients With Catecholamine-Resistant Distributive Shock - PHOENIX
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 377
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •SIRS Inclusion Criteria:
- •- Patients with SIRS as characterized by two or more of the following conditions (worst values in a 24 hour period):
- •a) Either respiratory rate >= 20 breaths/minute, or partial pressure of arterial carbon dioxide (PaCO2) <= 32 torr, or mechanical ventilation;
- •b) Heart rate >= 90 beats/minute;
- •c) Either hyperthermia >= 38 ºC or hypothermia <= 36 ºC;
- •d) Either white blood cell (WBC) >= 12,000 cells/mm3, <= 4,000 cells/mm3, or >= 10% immature (band) forms.
- •Shock Inclusion Criteria:
- •Patients with adequate fluid resuscitation and requiring a norepinephrine dose of >= 0.3 mcg/kg/min for at least one hour to maintain a MAP >= 65 mmHg but <= 80 mmHg within the first 36 hours of the initiation of norepinephrine treatment. If a patient reaches the Norephinephrine dose threshold for enrolment, but begins to improve before randomization, then the patient should only be randomized if the Norepinephrine dose is still >=0,2 mcg/kg/min
排除标准
- •- Patients who lack documented Informed Consent signed by the patient or his/her legally authorized representative
- •- Patients that are pregnant
- •- Patients less than 18 years old
- •- Patients with suspicion of or active treatment for coronary artery disease within 60 days of enrollment defined as any of the following: acute myocardial infarction with an abnormal ECG indicative of myocardial infarction or abnormal regional wall motion (echocardiography), unstable angina with abnormal regional wall motion (echocardiography) and/or EF < 35%, coronary revascularization (angioplasty, stenting, coronary bypass graft) if EF < 35%
- •- Patients who have received a stent within the last 12 months
- •- Patients with suspicion of or active treatment for malignant arrhythmia within 60 days of enrollment defined as any of the following: ventricular tachycardia, ventricular fibrillation, appropriate defibrillator firing in patient with AICD; Note: A peacemaker is not an exclusion criterion
- •- Patients with suspicion of or active treatment for congestive heart failure within 60 days of enrollment defined as any of the following: ejection fraction < 35% and LV end-diastolic dimension > 6.0 cm demonstrated by echo or MUGA, or hospitalization primarily for congestive heart failure, or NYHA Class IV congestive heart failure
- •- Patients with suspicion of or active treatment for aortic valve heart disease within 60 days of enrollment defined as any of the following: aortic valve stenosis with area < 1.0 cm2, or severe aortic insufficiency, or after aortic valve replacement if ejection fraction < 35%
- •- Patients with stage 3 or 4 solid tumors (TNM classification, group staging), hematologic malignancies with high tumor burden, CNS cancer (WHO stage 3 and 4) unless significant tumor mass was removed near occurrence of shock
- •- Patients with dead bowel likely to result in death. After surgical removal of the dead bowel the patient can be enrolled
- •- Patients receiving/scheduled to receive another investigational drug or have received an investigational drug in the previous 30 days
- •- Patients with known hypersensitivity to blood products
- •- Patients with hypovolemic shock from bleeding or other volume loss
- •- Patients who are likely to die within days for diseases or conditions other than catecholamine-dependent shock (e.g. multiple organ failure that is irreversible as distinct from multiple organ dysfunction that may resolve)
- •- Patients with Glasgow Coma Score <= 7 at the time of admission and prior to the administration of confounding medications such as narcotics, sedatives or neuromuscular blockers
- •- Patients that experienced trauma within the past 48 hours
- •- Patients that experienced burns within the past 48 hours
- •- Patients with anaphylactic shock
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