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临床试验/NCT00542516
NCT00542516已完成4 期

Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty: Hydroxyethyl Starch Versus Ringer's Lactate

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2006年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
48
试验地点
1
主要终点
HES expansion plasmatic efficacy

研究概览

简要总结

Currently the most use solution to volemic reposition in hip replacement arthroplasty is the crystalloid solution. This trial intends to compare two different volemic replacements: HES and Ringer's lactate. This research has been analyzing hemodynamic parameters and the coagulation status before and after the pre-expansion with the solutions above mentioned.

详细描述

This trial is randomized an blind to the physician who is analyzing the results.It has been select adults; both sex; ASA I and II. These patients must be submitted to hip arthroplasty replacement. The anesthesia technique is single shot spinal anesthesia. Primary endpoint: assessment alternative; technique replacement volemic with HES 130/04. Secondary endpoint: haemostatic abnormalities; blood loss; transfusion blood.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients involved: adults, ASA I and II;
  • Surgery: hip replacement arthroplasty.

排除标准

  • Allergy starch;
  • Dysfunction renal;
  • Heart insufficiency;
  • Morbid obesity.

研究组 & 干预措施

HES 130/04

Experimental

Pre-expansion with HES

干预措施: Hydroxyethyl Starch (Drug)

Ringer's lactate

Active Comparator

Pre-expansion with Ringer's lactate

干预措施: Hydroxyethyl Starch (Drug)

Ringer's lactate

Active Comparator

Pre-expansion with Ringer's lactate

干预措施: Ringer's lactate (Drug)

结局指标

主要结局

HES expansion plasmatic efficacy

时间窗: 24 hours

次要结局

  • Blood transfusion(24 hours)
  • Haemostatic alterations(24 hours)

研究者

申办方类型
Other

研究点 (1)

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