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临床试验/ISRCTN95679074
ISRCTN95679074进行中(未招募)未知

Improving cardiac function in high-risk surgical patients: exercise testing, biomarkers and beta-blockade

York Teaching Hospital NHS Foundation Trust0 个研究点目标入组 44 人开始时间: 2018年1月23日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
入组人数
44

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Aged 55 years or over
  • 2. Scheduled for major intra-abdominal surgery
  • 3. Presenting for routine CPET as part of pre-assessment
  • 4. Not currently taking any BB medication and not taken BB medication within 1 month prior
  • 5. Consent to GP being informed
  • 6. VE/VCO2 34 or greater on CPET, as either the value measured at VO2@AT, or the lowest measured value, plus at least one of the following:
  • 6.1. Presence of a known history of a clinical risk factor for major adverse cardiac events (MACE) after surgery
  • 6.1.1. Ischaemic heart disease
  • 6.1.2. Cerebrovascular disease
  • 6.1.3. Renal insufficiency (creatinine > 170 ?mol.L-1)
  • 6.1.4. Chronic heart failure
  • 6.2. Evidence of abnormal myocardial response on exercise testing
  • 6.2.1. Flattened or inflecting oxygen uptake to heart rate response (oxygen pulse response, VO2/HR, panel 2)
  • 6.2.2. Flattened or inflecting oxygen uptake to work rate response (VO2/Watt, panel 3)
  • 6.3. Anaerobic threshold <11ml/kg/min

排除标准

  • 1. Refusal or unable to give informed consent
  • 2. Fewer than 7 days before scheduled surgery at pre-assessment appointment surgery
  • 3. Current beta blocker medication or having taken any beta blocker within 1 month prior
  • 4. Contra-indications to BB medication including:
  • 4.1. Bronchial asthma
  • 4.2. Reversible airways disease
  • 4.3. Decompensated heart failure (NYHA class IV)
  • 4.4. Fluid overloaded
  • 4.5. Hypotensive
  • 4.6. Severe liver impairment
  • 4.7. Second or third degree A-V block (unless pacemaker fitted)
  • 4.8. SA block
  • 4.9. Sick sinus syndrome (unless pacemaker inserted)
  • 4.10. Cardiogenic shock
  • 4.11. Bradycardia (heart rate less than 60 bpm)
  • 4.12. Prinzmetal's angina
  • 4.13. Untreated Phaeochromocytoma
  • 4.14. Metabolic acidosis
  • 4.15. Poor blood circulation in the hands and feet
  • 4.16. Severe peripheral arterial insufficiency
  • 4.17. Known hypersensitivity to bisoprolol or its ingredients (lactose monohydrate, silica colloidal anhydrous, crospovidone (Type A), crospovidone (Type B), povidone 30, sucrose, magnesium stearate)
  • 4.18. Co-prescription with negative chronotropic agents such as digoxin, diltiazem, verapamil, amiodarone
  • 4.19. Co-prescription with medications that affect the plasma concentrations of bisoprolol such as rifampin, cimetidine, quinidine, fluoxetine, paroxetine, propafenone, digoxin, reserpine, monoamine oxidase inhibitors, clonidine

研究者

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