ISRCTN95679074进行中(未招募)未知
Improving cardiac function in high-risk surgical patients: exercise testing, biomarkers and beta-blockade
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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