The Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures: Effect on Acid-Base Status and Renal Functions
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intraoperative volume replacement therapy
研究概览
简要总结
This study compares the effect of infusion of two types of modern hydroxyethyl starch on the renal function and acid-base in patients undergoing urologic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
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
- •Age group above 18 years,
- •ASA І and ІІ,
- •Patients who will be scheduled to undergo radical prostatectomy or cystectomy with bladder replacement
排除标准
- •A known allergy to HES,
- •Renal insufficiency (serum creatinine of >2.5 mg/dL),
- •Significant hepatic disease (liver function tests more than three times the upper limit of normal),
- •Coagulation disorders (INR > 1.5).
研究组 & 干预措施
VOL group
patients will receive 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)
干预措施: 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany) (Drug)
TET group
patient will receive 6% HES 130/0.42 in a balanced electrolyte containing Na+140 mmol/L, Cl- 118 mmol/L, K +4 mmol/L, Ca++ 2.5 mmol/L, Mg++ 1 mmol/L, acetate- 24 mmol/L and malate-- 5 mmol/L
干预措施: Tetraspan, B. Braun, Melsungen, Germany (Drug)
结局指标
主要结局
Intraoperative volume replacement therapy
时间窗: From randomization, for the duration of surgery and up to transfer from the operating room to the ICU or recovery room, an expected average of 6 hours
volume of the study drug in milliliters that will be needed for hemodynamic stabilization until the end of surgery (ie, the cumulative volume of the study drug in milliliters administered up to this time point).
次要结局
- Acid base and Renal function(24 hours after randomization)
研究者
Ahmed Mukhtar
Assistant professor of anesthesia Cairo University
Kasr El Aini Hospital