The Effects of Hyperbaric Oxygen Preconditioning On Cardiovascular Protection & Ischemic Reperfusion Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Serum Troponin-T
研究概览
简要总结
The purpose of this study was to determine if treating patients who have coronary heart disease with hyperbaric oxygen (HBO) prior to coronary artery bypass graft (CABG) surgery reduces injury to the heart and vascular system during and after surgery. Furthermore, this study also aims to identify some of the post CABG clinical effects of HBO treatment prior to CABG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 20 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective first time CABG
- •Patients with at least 1 vessel coronary artery disease undergoing on- pump CABG
排除标准
- •Age ≤ 20 years or ≥ 85 years
- •Ejection fraction < 30%
- •Unstable angina
- •Recent myocardial infarction (< 1 month)
- •Any additional cardiac disease (e.g. arrythmia, aneurysm, valvular/septal disease, dissection or elevated pulmonary artery pressure)
- •Any end stage organ failure (e.g. renal and respiratory failure)
- •History of chronic obstructive pulmonary disease (COPD)
- •Pneumothorax
- •Pulmonary bullae
- •Convulsions
- •Current history of malignancy
- •Severe myopia or intraocular lens
- •Patients on K+(ATP) Channel Openers e.g. Nicorandil, Oral Hypoglycemics, Opioid Analgesics, Catecholamines.
研究组 & 干预措施
B
Patients in this arm were treated with HBO prior to CABG
干预措施: Hyperbaric Oxygen (Drug)
结局指标
主要结局
Serum Troponin-T
时间窗: Peri-operative
Serum soluble PSGL-1
时间窗: Peri-operative
Serum soluble P-Selectin
时间窗: Peri-operative
Serum soluble E-Selectin
时间窗: Peri-operative
Myocardial Hsp72 protein
时间窗: Intra-operative (During CABG)
Myocardial eNOS protein
时间窗: Intra-Operative (During CABG)
Serum soluble ICAM-1
时间窗: Peri-operative
次要结局
- Atrial Fibrillation(Post operative)
- Inotrope usage(Post operative)
- Blood loss(Post operative)
- Duration of mechanical ventilation(Post Operative)
- All cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter(Peri-operative)
- Length of stay in ICU(Post-operative)
- Duration of endotracheal intubation(post operative)
- Low cardiac output status(Post operative)
- Pulmonary complications(Post operative)
- Renal Complications(Post operative)
- Cerebrovascular complications(Post operative)
- Gastrointestinal complications(Post operative)
- Wound complications(Post operative)
- Cost of ICU stay(Post operative)
