Comparison of Albumin and Ringer's Solution for Optimization of the Plasma Volume and Hemodynamics During Laparoscopic Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Plasma volume expansion after a fluid bolus
研究概览
简要总结
A short bolus infusion of fluid, called "fluid challenge" is commonly recommended for fluid treatment during longer surgery. However a prolonged increase of the blood volume is a prerequisite to recommend the technique. The purpose with the study is to examine the plasma expanding effect of three different fluid challenge strategies (acetated Ringers 4 ml/kg body weight, albumin 5% 4 ml/kg body weight or albumin 20% 1 ml/kg body weight), using hemoglobin as a dilution indicator.
详细描述
60 patients scheduled for laparoscopic abdominal surgery, with a duration exceeding 90 minutes will be included in the study. These are randomized to three different groups (20 in each groups): The first group of patients will receive boluses of acetated Ringers 4 ml/kg body weight. The second albumin 4 ml/kg body weight and the third group albumin 20% 1 ml/kg body weight.
Hemoglobin, albumin and colloid osmotic pressure (COP) is sampled the day before surgery and in the morning directly prior to the anesthesia. Bioimpedance, urine osmolality and urine-creatinin are also measured. After induction of surgery a Cardio Q probe is inserted threw the nose into the esophagus, for circulatory measurements. Initial/baseline blood samples are taken after insufflation of carbon dioxide to the abdomen. Before every bolus of fluid and 5, (10), 15, 20, 30, 40, (50) and (60) minutes new blood samples are taken for determination of hemoglobin, albumin and COP. Artery blood gases are sampled 15 minutes after every infusion or depending on the clinical need.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent to participate in the study
- •For women: relevant contraceptive, menopausal or a negative pregnancy test.
- •ASA category I to III
- •Laparoscopic abdominal surgery, with a duration of at least 90 minutes.
- •18 to 80 years
排除标准
- •Patients with known cardiac failure
- •<18 or >80 years
- •known allergy to albumin
- •extracellular hyperhydration or hypervolemia
- •kidney failure
- •pregnancy or planned pregnancy
研究组 & 干预措施
acetated Ringers
The circulatory effect of a bolus infusion with 4 ml/kg body weight of acetated Ringers will be studied. If cardiac output increase with 10% a second bolus will be infused and further studied.
干预措施: acetated Ringers (Drug)
albumin 5%
The circulatory effect of a bolus infusion with 4 ml/kg body weight of Albumin 5% will be studied. If cardiac output increases with 10% a second bolus will be infused and further studied.
干预措施: albumin 5% (Drug)
albumin 20%
The circulatory effect of a bolus infusion with 1 ml/kg body weight of Albumin 20% will be studied. If cardiac output increase with 10% a second bolus will be infused and further studied.
干预措施: albumin 20% (Drug)
结局指标
主要结局
Plasma volume expansion after a fluid bolus
时间窗: 60 minutes after an intravenous fluid bolus
Plasma volume using hemoglobin as an indicator of dilution
次要结局
- Stroke Volume(60 minutes after an intravenous fluid bolus)
- Arterial Blood Pressure(60 minutes after an intravenous fluid bolus)
- Heart Rate(60 minutes after an intravenous fluid bolus)
- Bioimpedance(18 to 24 hours)
- arterial serum sodium(60 minutes after an intravenous fluid bolus)
- Fluid Balance(18 to 24 hours)
- Serum Creatinin(18 to 24 hours)
- arterial pH(60 minutes after an intravenous fluid bolus)
- arterial Base Excess(60 minutes after an intravenous fluid bolus)
- arterial serum chloride(60 minutes after an intravenous fluid bolus)
研究者
Joachim Zdolsek
consultant, assoc prof
University Hospital, Linkoeping