Phase IV, multicenter, prospective, randomized, open-label, controlled study on Landiolol in patients with septic shock resident in an Intensive Care Unit - LANDI-SEP

AOP Orphan Pharmaceuticals AG0 个研究点目标入组 200 人开始时间: 2017年9月21日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•1) Informed consent (signed informed consent by the patient or a legal representative or other country-specific documentation, as required)
•2) Age =18 years
•3) 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
•4) Tachycardia and/or tachyarrhythmia with heart rate =95 beats/min
•5) Norepinephrine infusion (any dose) at the time of study inclusion
•6) Patients must have undergone a haemodynamic optimization period of at least 12 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•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

•1. Any form of compensatory tachycardia
•2. ß-blocker treatment after septic shock diagnosis
•3. Sick Sinus syndrome
•4. Severe atrioventricular (AV) nodal conductance disorders (without pacemaker); 2nd or 3rd degree AV block
•5. A known serious cardiovascular condition such as ischemic stroke or transient ischaemic attack within last 6 months, or pre-existing heart failure New York Heart Association Class 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) exists
•12. Known sensitivity to any component of the study medication (e.g. Landiolol, mannitol)
•13. Participation in a clinical drug trial within 30 days prior randomization or prior participation in the LANDI-SEP trial
•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
•17. Anticipated to be in need of beta-blocker therapy prior to vasopressor discontinuation due to their prior medication/ medical history (Investigator´s opinion)

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