An Open Label Feasibility Trial Investigating FE 202158 as Potential Primary Vasopressor Treatment in Patients With Vasodilatory Hypotension in Early Septic Shock.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Time to Septic Shock Resolution
研究概览
简要总结
The purpose of this trial is to investigate the potential of FE 202158 as a treatment which can stabilize blood pressure for treatment of patients in early septic shock.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form by the patient or a legal representative according to local regulations'
- •Man or women 18 years of age or older
- •Body weight below 115 kg for male patients and 100 kg for female patients
- •Proven or suspected infection
- •Septic shock, i.e. vasodilatory hypotension requiring vasopressor support
- •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
排除标准
- •Present or a history within the last 6 months of symptoms of acute coronary syndrome (myocardial infarction or unstable angina)
- •Known or suspected endocarditis
- •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
- •Known or suspected cardiac failure
- •Known or suspected infection with (HIV)-1, HIV-2, hepatitis B, or hepatitis C
- •Pregnancy or breastfeeding
- •Any cause of hypotension other than early septic shock
- •Use of vasopressin or terlipressin within 7 days prior to start of IMP infusion
- •Proven or suspected acute mesenteric ischemia, as judged by the investigator
- •Known episode of septic shock within 1 month prior to screening
- •Death anticipated within 24 hours, or due to the underlying disease within 3 months
- •Known past or current 2nd and 3rd degree AV-block without a well functioning pacemaker
- •Brain injury within current hospitalisation
- •Present hospitalisation with burn injury
- •Symptomatic peripheral vascular disease including Raynaud's syndrome
- •Previously included in this trial
- •Intake of an Investigational Medicinal Product (IMP) within the last 3 months (or longer if judged by the Investigator to possibly influence the outcome of the current study)
- •Known participation in another interventional clinical trial
- •Considered by the investigator to be unsuitable to participate in the trial for any other reason
研究组 & 干预措施
Drug
FE 202158
干预措施: FE 202158 (Drug)
结局指标
主要结局
Time to Septic Shock Resolution
时间窗: Day 1 up to Day 28
The Kaplan-Meyer estimation of time to out of septic shock was estimated where time to (first) septic shock resolution was defined as time of end of infusion regimen. Intermittent off treatment periods were regarded as part of the shock duration. Time to all but one patient out of septic shock is presented.
Infusion Rate of FE 202158
时间窗: Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
Infusion rate of FE 202158 was presented from Day 1 up to Day 7.
Cumulative Dose of Norepinephrine
时间窗: Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Cumulative dose of norepinephrine was calculated from Day 1 up to Day 7.
Cumulative Dose of FE 202158
时间窗: Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
Cumulative dose of FE 202158 was calculated from Day 1 up to Day 7.
Infusion Rate of Norepinephrine
时间窗: Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Infusion rates and all changes in infusion rates of norepinephrine were recorded continuously during the 7 day maximum treatment period.
Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine
时间窗: Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
Mean arterial pressure (MAP) was measured intra-arterially on a continuous basis. Success percentage of patients maintaining target/adequate MAP (\>60 mmHg) without norepinephrine is presented.
次要结局
- Urinary Output(Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.)
- Morbidity Assessment(Day 1 up to Day 28)
- Summary of Investigator Reported Outcomes(Day 1 up to Day 2)
- Mortality(Day 1 up to Day 28)
- Fluid Balance(Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.)
- Graded Morbidity(Day 1 up to Day 28)
- Adverse Effects on Lab Parameters, Vital Signs and Electrocardiogram(Day 1 up to Day 7, and at follow-up assessments performed 24-72 hours after end of IMP infusion)