Investigating FE 202158 as Potential Primary Treatment in Patients With Early Septic Shock
2017年2月20日 更新者:Ferring Pharmaceuticals
An Open Label Feasibility Trial Investigating FE 202158 as Potential Primary Vasopressor Treatment in Patients With Vasodilatory Hypotension in Early Septic Shock.
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.
研究概览
研究类型
介入性
注册 (实际的)
31
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Drug
FE 202158
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine
大体时间: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.
|
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
大体时间: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.
|
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
大体时间: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.
|
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 Norepinephrine
大体时间: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.
|
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 Norepinephrine
大体时间: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.
|
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.
|
Time to Septic Shock Resolution
大体时间: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. |
Day 1 up to Day 28
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Urinary Output
大体时间: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.
|
The urinary output was recorded every 24 hours up to Day 7, or as long as the patient was in intensive care unit.
|
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.
|
Fluid Balance
大体时间: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.
|
The fluid balance (accumulated input/output) was recorded in 24-hour collecting periods when the patient was in the intensive care unit and during the infusion of FE 202158.
|
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.
|
Summary of Investigator Reported Outcomes
大体时间:Day 1 up to Day 2
|
Investigator reported outcome on FE 202158 performance.
Answers were graded on a visual analogue scale (VAS) from 0 to 10, 0 being the worst and 10 being the best outcome.
|
Day 1 up to Day 2
|
Morbidity Assessment
大体时间:Day 1 up to Day 28
|
Percentage of all the "Days alive and out/free of" intensive care unit, hospital, dialysis, or ventilation within Day 28 were summarized.
Patients dying before or at Day 28 were counted as zero.
|
Day 1 up to Day 28
|
Graded Morbidity
大体时间:Day 1 up to Day 28
|
Collection of data on graded morbidity was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.
|
Day 1 up to Day 28
|
Mortality
大体时间:Day 1 up to Day 28
|
Collection of data on mortality was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.
|
Day 1 up to Day 28
|
Adverse Effects on Lab Parameters, Vital Signs and Electrocardiogram
大体时间:Day 1 up to Day 7, and at follow-up assessments performed 24-72 hours after end of IMP infusion
|
Significant changes for vital signs (blood pressure, heart rate, mean arterial pressure), electrocardiogram (ECG), and laboratory parameters (clinical chemistry, haematology, haemostasis, and urinary parameters).
|
Day 1 up to Day 7, and at follow-up assessments performed 24-72 hours after end of IMP infusion
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年6月1日
初级完成 (实际的)
2013年11月1日
研究完成 (实际的)
2013年11月1日
研究注册日期
首次提交
2012年5月11日
首先提交符合 QC 标准的
2012年6月5日
首次发布 (估计)
2012年6月6日
研究记录更新
最后更新发布 (实际的)
2017年3月23日
上次提交的符合 QC 标准的更新
2017年2月20日
最后验证
2017年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
FE 202158的临床试验
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Changchun Intellicrown Pharmaceutical Co. LTD招聘中
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Sichuan Enray Pharmaceutical Sciences Company招聘中宫颈癌 | 乳腺癌 | 大肠癌 | 卵巢癌 | 肺癌 | 晚期实体瘤 | 胰腺癌 | 甲状腺癌 | 外阴癌中国
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Fondation Ophtalmologique Adolphe de Rothschild招聘中
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Swiss Federal Institute of TechnologyUnited States Agency for International Development (USAID); Quadram Institute Bioscience; Genetics... 和其他合作者完全的