NCT01478126已完成3 期
Prospective Randomized Study of Glutamin Protective Properties in Cardiac Surgery.
Meshalkin Research Institute of Pathology of Circulation1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年1月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Troponin I
研究概览
简要总结
The purpose of this study is to determine whether perioperative glutamine administration possess protective properties on internal organs (heart and gut) in patients with coronary atherosclerosis, operated under cardiopulmonary bypass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with coronary artery disease operated on under cardiopulmonary bypass
排除标准
- •Ejection fraction<40%
- •Viral hepatitis
- •Liver cirrhosis
- •Cholecystitis
- •Pancreatitis
- •Chronic severe gastrointestinal disease
- •Surgery on gastrointestinal tract in patient's medical history
研究组 & 干预措施
Glutamine
Experimental
Intravenous glutamine infusion perioperatively and 24 hours after surgery
干预措施: N(2)-L-Alanine L-Glutamine dipeptide (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Troponin I
时间窗: Induction to anaesthesia, 30 min after cardiopulmonary bypass, 6, 24 hours after CPB
次要结局
- alpha-glutathione s-transferase(Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB)
- Alanine Aminotransferase (ALT)(Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB)
- Aspartate transaminase (AST)(Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB)
- Glutathione(Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB)
- Liver Fatty Acid Binding Protein(Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB)
- Intestinal fatty acid binding protein(Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB)
- Serum HSP-70(Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB)
- SH-groups(Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB)
研究者
研究点 (1)
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