EUCTR2017-002138-22-IT进行中（未招募）1 期
Phase IV, multicenter, prospective, randomized, open-label, controlled study on Landiolol in patients with septic shock resident in an Intensive Care Unit (LANDI-SEP) - LANDI-SEP
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
入选标准
- •1) Confirmed septic shock:
- •a. Confirmed or suspected infection
- •b. Acute increase of =2 points on SOFA Score
- •c. Need for continuous vasopressor therapy to maintain a mean arterial pressure (MAP) of >65 mmHg despite adequate fluid resuscitation
- •d. Blood lactate >2mmol/L (18mg/dl)
- •Presence of blood lactate >2mmol/L (18mg/dl) and increase of =2 points on SOFA Score are only necessary for the diagnosis of septic shock but not at time of study inclusion
- •2) Tachycardia and/or tachyarrhythmia with heart rate =95 beats/min
- •3) Norepinephrine infusion rate =0.2µg/kg/min at the time of study inclusion
- •4) Patients must have undergone a hemodynamic optimization period of at least 24 hours but a maximum of 36 hours, during which period they received continuous vasopressor treatment and standard treatment for septic shock according to the SSCG 2016 guidelines
- •5) Age =18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1.Any form of compensatory tachycardia
- •2.ß-blocker treatment within 7 days prior randomization
- •3.Sick Sinus syndrome, or 2nd or 3rd degree AV block
- •4.Patients with any form of cardiac pacing
- •5.A known serious cardiovascular condition such as ischemic stroke or transient ischemic attack within last 6 months, or preexisting heart failure New York Heart Association Class III or IV
- •6.Cardiogenic shock
- •7.MAP <65 mmHg
- •8.Known pulmonary hypertension
- •9.Known terminal illness other than septic shock with expected patient's survival <28 days
- •10.Known presence of an advanced condition to withhold life-sustaining treatment
- •11.Patients for whom a Do Not Resuscitate (DNR) exist
- •12.Known sensitivity to any component of the study medication (e.g. mannitol)
- •13.Participation in a clinical drug trial within 30 days prior randomization
- •14.Any condition that, in the Investigator's opinion, makes the subject unsuitable for study participation (to be documented)
- •15.Pregnant or breast-feeding patients
- •16.Untreated Pheochromocytoma
研究者
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