EUCTR2009-010798-19-BE进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, infusion proof-of-concept trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending doses of FE 202158 in patients with vasodilatory hypotension in early septic shock
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All of the following inclusion criteria must be met before the subject can enter into the trial:
- •1. Signed informed consent form by the patient or a legal representative according to local regulations
- •2. Man or woman 18 years of age or older
- •3. Proven or suspected infection
- •4. Vasodilatory hypotension (systolic blood pressure less than 90 mmHg or decrease in systolic blood pressure by at least 40 mmHg for more than one hour) that has not responded to fluid (20 ml/kg of crystalloid or 10 ml/kg of colloid), requiring norepinephrine at a dose of at least 0.1 µg/kg/min, or a minimal dose of 11.5 µg/min (males) and 10.0 µg/min (females) for patients with a body weight above 115 kg (men) or 100 kg (women) for at least 2 hours
- •5. Signs of tissue hypoperfusion (at least one of the following criteria): Oliguria (< 0.5 ml/kg/hr for 1 hour), decreased Glasgow Coma Score (< 13) if fully assessable, i.e. only in non-sedated and non-ventilated patients, decreased PaO2/FiO2 ratio (= 300 in the presence of other dysfunctional organs or systems than the lung or = 200 if the lung is the only dysfunctional organ), increased arterial blood lactate (= 2.5 mmol/L).
- •6. Willing to use an adequate barrier method or hormonal method of contraception, if not abstinent, from informed consent to one week after the end of infusion of study medication.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Any subject meeting one or more of the following exclusion criteria can not be included in the trial:
- •1. Present or a history (within the last 5 years) of acute coronary syndrome (myocardial infarction or unstable angina). Patients who have been asymptomatic for 6 months after coronary revascularisation are eligible. Known or suspected coronary ischemia.
- •2. Hypovolaemia suspected on clinical grounds, e.g. cold extremities with delayed capillary filling, low cardiac filling pressure, marked systolic or pulse pressure variation or positive leg raising test
- •3. Known or suspected cardiac failure, e.g. CI < 3 l/min/ m2, left ventricular ejection fraction (LVEF) = 40 %, bilateral pulmonary edema/congestion and cardiomegaly, ScvO2 (superior vena cava) < 64 %, known or suspected coronary ischemia, cold extremities with delayed capillary filling, distended neck veins.
- •4. Pregnancy or breastfeeding
- •5. Any cause of hypotension other than early septic shock
- •6. Use of vasopressin or terlipressin for blood pressure support during the current hospital admission
- •7. Proven or suspected acute mesenteric ischemia, as judged by the investigator
- •8. Known episode of septic shock within 1 month prior to randomisation
- •9. Death anticipated within 24 hours
- •10. Underlying chronic heart disease, including heart failure NYHA class III or IV
- •11. Known past or current 2nd and 3rd degree AV-block without a well functioning pacemaker
- •12. Hyponatremia (serum/plasma sodium <130 mmol/L)
- •13. Traumatic brain injury (Glasgow Coma Score <8 prior to onset of sepsis)
- •14. Present hospitalisation with burn injury
- •15. Symptomatic peripheral vascular disease including Raynaud’s syndrome
- •16. Previously randomised in this trial
- •17. Intake of an IMP within the last 3 months (or longer if judged by the Investigator to possibly influence the outcome of the current study)
- •18. Known participation in another clinical trial
- •19. Considered by the investigator to be unsuitable to participate in the trial for any other reason
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