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临床试验/NCT02638623
NCT02638623已完成不适用

Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery and Reduce Complications in Arthroplasty Patients?

West Virginia University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Number of Participants With Postoperative Complications

研究概览

简要总结

The investigators are testing the hypothesis that administering 2L of body temperature warmed lactated ringer's intravenously prior to surgery can optimize the postoperative and recovery of patients undergoing total hip and total knee arthroplasty.

详细描述

Hip and knee arthroplasty are safe and reliable surgeries for the majority of patients, but a small percentage experience major complications such as myocardial infarction, deep vein thrombosis (DVT), and pulmonary embolism (PE). As these complications are related to local tissue hypoxemia and patient immobility, interventions that can improve the ability of the heart to deliver blood to the tissue and help patients mobilize earlier in their postoperative course may decrease these complications. Based on recent evidence, it has been shown that many patients are dehydrated before surgery, which can make them feel nauseous, tired, and increase their perception of pain making them less likely to mobilize. This predisposes them to DVTs, pulmonary embolism, nausea and vomiting. Peri-operative dehydration can also decrease the ability of the lungs to oxygenate the blood properly and can place additional stress on the heart, which can increase the risk of heart attacks. The specific aim is to determine if patients' peri-operative hemodynamics can be improved with preoperative administration of 2 L of lactated ringers, and consequently reduce postoperative complications and improve recovery in arthroplasty patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients >= 18 years of age, undergoing a total primary knee or hip arthroplasty

排除标准

  • Patients weighing less than 80 kg.
  • Patients undergoing irrigation and debridement, explantation, or revision will not be eligible.
  • history of kidney disease, congestive heart failure, pulmonary edema, cirrhosis of the liver, or history of systemic fluid overloard will be excluded from the study.
  • No one will be excluded based on gender, ethnicity or race.

研究组 & 干预措施

Drug Lactated Ringer

Active Comparator

Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement

干预措施: Lactated Ringer (Drug)

Placebo

Placebo Comparator

Covered empty bag with no hydration supplement

干预措施: Placebo (Drug)

结局指标

主要结局

Number of Participants With Postoperative Complications

时间窗: 90 days post surgery

Patients found to have a 90-day postoperative complication categorized as Infection, CHF/Fluid overload, MI, DVT/PE, other

次要结局

  • Volume of Fluid Administred(surgical period)
  • 90 Day Readmission Count(90 days postop)
  • Duration of Surgery(Incision to end of surgery)
  • Emesis Episodes(Hospital Stay)
  • Duration of Hospital Stay (Hours)(Surgery to hospital discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Dietz, MD

Assistant Professor, MD

West Virginia University

研究点 (1)

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