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临床试验/NCT00469716
NCT00469716已完成4 期

Infusion of Hypertonic Saline-hetastarch in Cardiac Surgery

Haukeland University Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2007年4月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Cardiac output, intrathoracic blood volume, extravascular lung water, global enddiastolic volume

研究概览

简要总结

Cardiopulmonary bypass(CPB) is associated with increased fluid extravasation and edema formation. A continuous infusion of a mixture of hypertonic saline/hydroxyethyl starch (HSH)during CPB reduced fluid extravasation and total fluid gain during bypass in an animal model. We hypothesize that a continuous infusion of HSH will reduce fluid load and increase hemodynamic and respiratory functions in patients undergoing coronary artery bypass with CPB.

详细描述

Cardiopulmonary bypass (CPB) is associated with fluid overload and edema formation occasionally resulting in vital organ dysfunction affecting heart, respiratory system , gastrointestinal tract and brain. Hyperosmolar/hyperoncotic preparations (HSH/HSD) have been used in cardiac surgery essentially with the aim to mobilize fluid excess and improve postoperative cardiorespiratory function.Most studies dealing with the administration of HSD or HSH during and after CPB, have used protocols recommended for treatment of severe hypovolemia and shock, that is 4 mL/kg as a bolus, given within minutes.In animal experiments we have used HSD or HSH, 1 mL/kg/h to a total dose of 4 mL/kg during CPB. The use of HSH/HSD reduced the total fluid gain about 50 % and resulted in significantly lower content of tissue water in vital organs as heart and lungs. In the actual clinical trial we hypothesize that a continuous infusion of HSH will reduce fluid load and increase hemodynamic and respiratory functions monitored with the PiCCO system in patients undergoing coronary artery bypass with CPB.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for elective coronary artery bypass graft surgery

排除标准

  • Age <18 years or > 75 years
  • BMI< 18 or > 30
  • Left ventricular ejection fraction < 40%
  • Emergency operations
  • Additional valvular diseases
  • Impaired renal function
  • Serum sodium> 145 mmol/l
  • Hematocrit< 30%
  • Use of clopidogrel the last 5 days

结局指标

主要结局

Cardiac output, intrathoracic blood volume, extravascular lung water, global enddiastolic volume

时间窗: 12 hours

次要结局

  • Time to extubation, fluid balance, paO2/FiO2- ratio, frequency of atrial fibrillation, cytokines, time to ICU-release and hospital release.

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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