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临床试验/NCT01463917
NCT01463917Unknown4 期

Use of Hypertonic Versus Isotonic Solutions in Off Pump Coronary Artery Bypass Graft Surgery Targeting the Left Marginal Branch

Hospital Pitangueiras1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
20
试验地点
1
主要终点
Use of vasoactive drugs in left marginal branch off pump CABG surgery

研究概览

简要总结

This is a comparison between Hypertonic versus isotonic solution in a double blind randomized trial for off pump Coronary Artery Bypass Graft (CABG) surgery targeting the left marginal branch.

Hypertonic solution should provide better tolerance for heart mobilization with less volume expansion and less drugs.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Off pump CABG targeting the left marginal branch

排除标准

  • On pump surgery

研究组 & 干预措施

Hypertonic

Active Comparator

Use of Hypertonic solution during left marginal branch CABG surgery.

干预措施: Hypertonic solution (Drug)

Isotonic

Placebo Comparator

Use of Isotonic solution during left marginal branch CABG surgery.

干预措施: Isotonic (Drug)

结局指标

主要结局

Use of vasoactive drugs in left marginal branch off pump CABG surgery

时间窗: time related to left branch coronary anastomosis for drug need.

Comparison between hypertonic and isotonic solutions for need of vasoactive drugs with heart mobilization during left marginal branch off pump CABG surgery. Data will be collected respectively at 1, 5 and 10 minutes after beggining the left branch coronary anastomosis. Data will be type of drug need and dosage until the end os the anastomosis.

次要结局

  • Fluid balance(Operative period and first operative day)

研究者

发起方
Hospital Pitangueiras
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto Rocha e Silva

Chief, Adult Heart Surgery, MD PHD in Cardiovascular Surgery

Hospital Pitangueiras

研究点 (1)

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