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临床试验/NCT01681251
NCT01681251已完成1 期

Goal Directed Therapy for Patients Undergoing Major Vascular Surgery

University of Manitoba2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
2
主要终点
Length of Stay

研究概览

简要总结

The management and delivery of intravenous fluids during surgical operations is one of the important duties for anesthesiologists.

The goal of this study was to determine if goal directed fluid therapy, titrated using the FloTrac monitor's measurement of stroke volume variation results in a decrease in the length of stay of patients undergoing open abdominal aneurysm repair.

详细描述

The management and delivery of intravenous fluids during surgical operations is one of the important duties for anesthesiologists. There is a growing body of evidence that fluid overload in surgical patients is associated with decreased wound healing, slower return of gut function, anastomotic breakdown, pulmonary edema and post-operative visual changes.

In the United States, abdominal aortic aneurysms are diagnosed in 190,000 people per year, and over 50,000 of those have the aneurysm repaired5. Recent advances in endovascular techniques have allowed many of these patients to forego an open repair. However, because of technical difficulties, many patients still require an open repair.

The most common cause of morbidity in these patients is related to post-operative gastrointestinal tract dysfunction. This usually involves an adynamic ileus that the patients develop on the fourth post-operative day. This delays their tolerance of enteral foods and lengthens their hospital stay and hospital costs. It also has the potential of causing more morbidity in that patients may require total parenteral nutrition while awaiting return of bowel function.

There are several causes of this gastrointestinal morbidity including direct mechanical trauma to the bowel during surgery and activation of the inflammatory cascade. These factors are unfortunately not modifiable by the team caring for the patient. One factor that is modifiable is the amount and type of intravenous fluids administered to the patient.

Typically, anesthesiologists decide on the amount of fluid to administer to patients based on parameters such as heart rate, blood pressure and urine output. These are unfortunately unreliable in determining a patient's volume status, as these parameters can be within the normal range, and a patient might still have inadequate perfusion to their vital organs. Further, clinician's reliance on blood pressure as a target for fluid administration ignores the fact that organs require blood flow as well as pressure to function optimally. Until recently, the only way to measure blood flow was with the insertion of a pulmonary artery catheter. Based on several studies showing a lack of benefit of this invasive procedure, it has fallen out of favor in the non-cardiac arena. Newer monitors of cardiac output that can be attached to a patients arterial catheter (commonly placed for major surgical procedures) offer an alternative method for clinicians to measure cardiac output.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical class I-III patients over the age of 18 years
  • Presenting for elective open repair of abdominal aortic aneurysms.

排除标准

  • Weight >120kg
  • Known or suspected valvular aortic insufficiency
  • Renal Dysfunction (serum creatinine >150 μmol/l)
  • Pre-existing bowel dysfunction
  • Active congestive heart failure

结局指标

主要结局

Length of Stay

时间窗: Up to 180 days.

Patients will be assessed for fitness for hospital discharge. This will be used to calculate the length of stay.

次要结局

  • Fluid balance(7 days)
  • Urine output(7 days)
  • Requirement for red blood cell transfusion(7 days)
  • Total Crystalloid Use(5 days)
  • Total Colloid Use(5 days)
  • Serum creatinine(7 days)
  • Postoperative complications(28 days)
  • Neutrophil gelatinase associated lipocalnin (NGAL) levels(Pre-op, immediately post op, 6 hours post-op and 24 hours post-op)

研究者

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

Dr. Duane Funk

Assistant Professor

University of Manitoba

研究点 (2)

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