Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery
2012年6月25日 更新者：Fresenius Kabi Japan
Examination of Volume Effect and Safety of 6 % Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery - an Uncontrolled, Open-labelled, Multi-centre Study
The study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for restoration and maintenance of hemodynamics during the investigational period in patients undergoing major elective surgery.
Up to 50 mL 6% hydroxyethyl starch/kg body weight will be administered from start of surgery until two hours after end of surgery.
The study hypothesis is that 6 % hydroxyethyl starch 130/0.4 will have a reliable volume effect and can be safely administered up to the dose limit.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
20
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Okayama、日本、700-8558
- Okayama University
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Tokyo、日本、162-8666
- Tokyo Women's Medical University
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Tokyo、日本、157-8535
- National Center for Child Health and Development
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Hokkaido
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Sapporo、Hokkaido、日本、060-8543
- Sapporo Medical University, School of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients undergoing major elective surgery
- Adults patients (≥20 years of age): expected blood loss of ≥ 1000mL Pediatric patients (<20 years of age): expected blood loss ≥ 15 mL/kg
- Adult patients: Routine measurement of Central Venous Pressure (CVP)
Exclusion Criteria:
- Known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs
- ASA classification ≥ IV
- Adult patients: renal failure with oliguria (<400 mL urin /24hours) and anuria Pediatric patients: renal failure with oliguria and anuria not related to hypovolemia
- Known bleeding disorders
- Other contra-indications according to the current SmPC of Voluven 6% solution for infusion.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：1个
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1: Up to 50 ml 6 % hydroxyethyl starch 130/0.4/kg
body weight administered intravenously from start of surgery (skin incision) until two hours after end of surgery.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Volume Effect
大体时间：Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery
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Volume effect will be assessed by evaluating the following parameter:
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Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fluid Balance
大体时间：From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery
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Fluid balance = fluid input vs. fluid output
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From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery
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Hemodynamics
大体时间：From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery
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From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery
|
|
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CVP
大体时间：Immediately before or after induction of anesthesia (depending on routine procedures), every hour after skin incision, and 2 hours after surgery
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Central venous pressure (CVP); not mandatory for pediatric patients
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Immediately before or after induction of anesthesia (depending on routine procedures), every hour after skin incision, and 2 hours after surgery
|
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Hematology
大体时间：One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, every hour after skin incision (adults), end of surgery (adults), 2 hours and 24 hours after end of surgery
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One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, every hour after skin incision (adults), end of surgery (adults), 2 hours and 24 hours after end of surgery
|
|
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Clinical Chemistry
大体时间：One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours after end of surgery (pediatric patients), and 24 hours after end of surgery
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One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours after end of surgery (pediatric patients), and 24 hours after end of surgery
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Hemostasis
大体时间：One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours and 24 hours after end of surgery
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One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours and 24 hours after end of surgery
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Body Temperature
大体时间：One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery, 2 hours and 24 hours after end of surgery
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One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery, 2 hours and 24 hours after end of surgery
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ECG
大体时间：Screening, 2 hours and 24 hours after end of surgery
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Not mandatory for pediatric patients
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Screening, 2 hours and 24 hours after end of surgery
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Urinalysis
大体时间：Immediately before or after induction of anesthesia (depending on routine procedures) and 24 hours after surgery
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Not mandatory for pediatric patients
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Immediately before or after induction of anesthesia (depending on routine procedures) and 24 hours after surgery
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Local and Systemic Tolerance
大体时间：After each administration of study drug
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After each administration of study drug
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(Serious) Adverse Events
大体时间：From signing informed consent until 28 days follow up
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From signing informed consent until 28 days follow up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Akiyoshi Namiki, MD, PhD、Emeritus Professor Sapporo Medical University; CEO, Otaru City Hospitals, Hokkaido, Japan
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年5月1日
初级完成 (实际的)
2010年12月1日
研究完成 (实际的)
2010年12月1日
研究注册日期
首次提交
2010年5月17日
首先提交符合 QC 标准的
2010年5月20日
首次发布 (估计)
2010年5月21日
研究记录更新
最后更新发布 (估计)
2012年6月26日
上次提交的符合 QC 标准的更新
2012年6月25日
最后验证
2012年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.