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Goal-directed Fluid Management Versus Conventional Fluid Management in Laparoscopic Hysterectomy

2019年10月2日 更新者:Gulseren Yilmaz、Kanuni Sultan Suleyman Training and Research Hospital

Comparison of Conventional Fluid Management With Pleth Variability Index Based Goal-directed Fluid Management in Elective Laparoscopic Hysterectomies.

Fluid management is critical in patients undergoing surgery. Goal-directed fluid management (GDFM) protocols have been shown to decrease the length of hospital stay. In this study, we aimed to compare the effects of conventional fluid management with Pleth Variability Index (PVI) guided on blood lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital stay.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Fluid management is critical in patients undergoing surgery. Goal-directed fluid management (GDFM) protocols have been shown to decrease the length of hospital stay in various kinds of surgical procedures. In this study, we aimed to compare the effects of conventional fluid management with Pleth Variability Index (PVI) guided on blood lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital stay. Patients will be randomized to one of the study arms: group1 (conventional fluid management arm) will receive 0.9 % NaCl at a rate of 4- 8 mL/kg/h, a 250-ml bolus crystalloid/ colloid injection will be administered when the mean arterial blood pressure (MAP) decreased below 65 mmHg.; group 2 (GDFM); group 2 (GDFM group) will receive 0.9 % NaCl at rate of 2 mL/kg/h, a 250-mL bolus crystalloid/colloid injection will be administered when PVI is higher than 13 % over 5 min. In both groups, when MAP is still < 65 mmHg after fluid bolus infusion, 5 mg i.v. bolus ephedrine will be administered. The groups will be compared concerning postoperative blood lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital stay.

研究类型

介入性

注册 (实际的)

100

阶段

  • 不适用

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

    • Please Enter The State Or Province
      • Istanbul、Please Enter The State Or Province、火鸡、34005
        • Kanuni Sultan Suleyman Training and Research Hospital

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

18年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Must be scheduled for laparoscopic hysterectomy Must be American Society of Anesthesiologists (ASA) class I-II-III

Exclusion Criteria:

- American Society of Anesthesiologists (ASA) class IV BMI > 40 kg/m2 Non-sinus heart rhythm MAP <65 mmHg at the onset of anesthesia induction Advanced renal and hepatic impairment Ejection fraction < 50 % Massive bleeding in the perioperative period

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:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:goal-directed fluid management (GDFM)
A pulse oximetry probe will be connected to the fourth finger of the hand in which there was not an arterial catheter in all patients and it will be wrapped so that it would not be affected by the external light. The pulse oximeter will then be connected to a monitor including the PVI software which automatically and continuously calculates the respiratory variations in the photoplethysmogram from data collected noninvasively via a pulse oximetry sensor. 0.9 % NaCl at a rate of 2 mL/kg/h will be infused in PVI- guided GDFM group, a 250-mL bolus crystalloid/colloid injection will be administered when PVI was higher than 13 % over 5 min.
A pulse oximetry probe which transfers data to the monitor with software able to calculate PVI data. The monitor automatically and continuously calculates the respiratory variations in the photoplethysmogram from data collected noninvasively via a pulse oximetry sensor.
无干预:Conventional fluid management group (CFMG)
This group will receive conventional fluid management described as follows: 0.9 % NaCl at a rate of 4- 8 mL/kg/h will be infused in CFGM group, a 250-ml bolus crystalloid/ colloid injection will be administered when the mean arterial blood pressure (MAP) decreased below 65 mmHg.

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
creatinine (mg/dl)
大体时间:3 hours after the operation
Difference in serum creatinine levels between the two groups 3 hours after the operation
3 hours after the operation

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。

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 (实际的)

2019年8月2日

初级完成 (实际的)

2019年9月1日

研究完成 (实际的)

2019年9月10日

研究注册日期

首次提交

2019年5月23日

首先提交符合 QC 标准的

2019年5月31日

首次发布 (实际的)

2019年6月3日

研究记录更新

最后更新发布 (实际的)

2019年10月3日

上次提交的符合 QC 标准的更新

2019年10月2日

最后验证

2019年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • Gulseren2

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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