STRESS-L: STudy into the REversal of Septic Shock with Landiolol (Beta Blockade) - Study into the Reversal of Septic Shock with Landiolol (Beta Blockade)

niversity Hospitals Birmingham NHS Foundation Trust0 个研究点目标入组 340 人开始时间: 2018年8月2日最近更新: 2018年9月3日

试验速览

暂无简介。

•Male or female aged 18 years or above
•Being treated on an ICU
•Septic shock according to internationally accepted definitions*
•Heart rate =95 bpm (24 hours after start of vasopressor therapy)
•Receiving vasopressor support with noradrenaline to maintain a target blood pressure for =24 hours
•Are being treated with noradrenaline at a rate = 0.1mcg/kg/min
•*Sepsis -3 definitions:
•o confirmed or suspected infection requiring antibiotic therapy
•o new organ dysfunction, as evidenced by an increase in SOFA score =2
•o a blood lactate >2 mmol/l at any point during shock resuscitation
•o vasopressor therapy to maintain mean arterial pressure (MAP) =65 mmHg
•In particular the presence of a blood lactate > 2 mmol/l is only necessary for the diagnosis of septic shock and is NOT necessary for randomisation 24 hours later.
•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 290
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•The participant may not enter the trial if any of the following apply:
•Noradrenaline infusion <0.1mcg/kg/min
•>48 hours after start of vasopressor therapy
•Having pre-existing severe cardiac dysfunction (NYHA grade 4 or more)
•Having pre-existing severe pulmonary hypertension (mean PA pressures > 55mmHg)
•Acute severe bronchospasm (due to asthma or COPD)
•Untreated second or third degree heart block
•Untreated pheochromocytoma
•Prinzmetal's angina
•A past history of ischaemic stroke or transient ischaemic attack (TIA) or untreated severe carotid stenosis.
•Advanced liver disease
•Having been treated with any beta-blocker drug in the seventy two hours prior to screening.
•Known sensitivity to beta-blockers
•Patient / legal representative unwilling to provide written informed consent
•Known to be pregnant
•Terminal illness other than septic shock with a life expectancy < 28 days
•Participants who have participated in another research trial involving an investigational medicinal product in the past 30 days.
•Patients in whom the clinical team feel are about to finish their noradrenaline therapy.

发起方

niversity Hospitals Birmingham NHS Foundation Trust