ISRCTN12600919已完成未知
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: 2017年12月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 340
研究概览
简要总结
2021 Protocol article in http://dx.doi.org/10.1136/bmjopen-2020-043194 (added 12/05/2021) 2023 Results article in https://doi.org/10.1001/jama.2023.20134 (added 26/10/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 14/08/2020:
- •1. Aged 18 years or above
- •2. Being treated on an ICU
- •3. Septic shock according to internationally accepted definitions*
- •4. Heart rate =95 bpm ( at the time of randomisation)
- •5. Receiving vasopressor support to maintain a target blood pressure for =24 hours
- •6. Are being treated with noradrenaline at a rate = 0.1 mcg/kg/min
- •*Sepsis -3 definitions:
- •1. Confirmed or suspected infection requiring antibiotic therapy
- •2. New organ dysfunction, as evidenced by an increase in SOFA score =2
- •3. A blood lactate >2 mmol/l at any point during shock resuscitation
- •4. 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.
- •Previous inclusion criteria from 28/02/2019 to 14/08/2020:
- •1. Male or female aged 18 years or above
- •2. Being treated on an ICU
- •3. Septic shock according to internationally accepted definitions*
- •4. Heart rate =95 bpm (24 hours after start of vasopressor therapy)
- •5. Receiving vasopressor support to maintain a target blood pressure for =24 hours
- •6. Are being treated with noradrenaline at a rate = 0.1 mcg/kg/min
- •*Sepsis -3 definitions:
- •1. Confirmed or suspected infection requiring antibiotic therapy
- •2. New organ dysfunction, as evidenced by an increase in SOFA score =2
- •3. A blood lactate >2 mmol/l at any point during shock resuscitation
- •4. 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.
- •Previous inclusion criteria:
- •1. Male or female aged 18 years or above
- •2. Being treated on an ICU
- •3. Septic shock according to internationally accepted definitions*
- •4. Heart rate =95 bpm (24 hours after start of vasopressor therapy)
- •5. Receiving vasopressor support with noradrenaline to maintain a target blood pressure for =24 hours
- •6. Are being treated with noradrenaline at a rate = 0.1 mcg/kg/min
- •*Sepsis -3 definitions:
- •1. Confirmed or suspected infection requiring antibiotic therapy
- •2. New organ dysfunction, as evidenced by an increase in SOFA score =2
- •3. A blood lactate >2 mmol/l at any point during shock resuscitation
- •4. 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
排除标准
- •Current exclusion criteria as of 14/08/2020:
- •1. Tachycardia as a result of pain, discomfort from medical devices (including endotracheal tubes), during interventions or other patient distress
- •2. Any form of vasodilatory shock that is not caused by sepsis
- •3. Noradrenaline infusion <0.1mcg/kg/min
- •4. >72 hours after start of vasopressor therapy
- •5. <12 hours since noradrenaline to treat a medical condition after than septic shock stopped
- •6. Having pre-existing severe cardiac dysfunction (NYHA grade 4 or more)
- •7. Having pre-existing severe pulmonary hypertension (mean PA pressures > 55mmHg)
- •8. Acute severe bronchospasm (due to asthma or COPD)
- •9. Untreated second or third-degree heart block
- •10. Untreated phaeochromocytoma
- •11. Prinzmetal's angina
- •12. A past history of ischaemic stroke or transient ischaemic attack (TIA) or untreated severe carotid stenosis.
- •13. Advanced liver disease with Child-Pugh Score of =B.
- •14. Known sensitivity to beta-blockers
- •15. Patient/legal representative unwilling to provide written informed consent
- •16. Known to be pregnant
- •17. Terminal illness other than septic shock with a life expectancy < 28 days
- •18. Participants who have been administered an investigational medicinal product for another research trial in the past 30 days
- •19. Patients in whom the clinical team feel are about to finish their noradrenaline therapy
- •20. Receiving extracorporeal membrane oxygenation (ECMO) treatment
- •Previous exclusion criteria from 12/11/2019 to 14/08/2020:
- •1. Any form of compensatory tachycardia
- •2. Any form of vasodilatory shock that is not caused by sepsis
- •3. Noradrenaline infusion <0.1mcg/kg/min
- •4. >72 hours in the current cause of septic shock after start of vasopressor therapy
- •5. Having pre-existing severe cardiac dysfunction (NYHA grade 4 or more)
- •6. Having pre-existing severe pulmonary hypertension (mean PA pressures > 55mmHg)
- •7. Acute severe bronchospasm (due to asthma or COPD)
- •8. Untreated second or third degree heart block
- •9. Untreated phaeochromocytoma
- •10. Prinzmetal's angina
- •11. A past history of ischaemic stroke or transient ischaemic attack (TIA) or untreated
- •12. Severe carotid stenosis.
- •13. Advanced liver disease with Child-Pugh Score of =B.
- •14. Known sensitivity to beta-blockers
- •15. Patient/legal representative unwilling to provide written informed consent
- •16. Known to be pregnant
- •17. Terminal illness other than septic shock with a life expectancy < 28 days
- •18. Participants who have been administered an investigational medicinal product for
- •19. Another research trial in the past 30 days
- •20. Patients in whom the clinical team feel are about to finish their noradrenaline
- •21. Therapy
- •22. Decision of withdrawal of care is in place or imminently anticipated
- •Previous exclusion criteria as of 28/02/2019:
研究者
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