Traditional Intravenous Versus Oral Fluid Management in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Body Weight
研究概览
简要总结
Purpose: Evidence-based guidelines on optimal perioperative fluid management have not been established in patients undergoing orthopaedic surgery. Recent randomized trials in major abdominal surgery suggest that large amounts of IV fluid may increase morbidity and hospital stay. This study will investigate the effects of two regimens of intraoperative fluid management ("traditional" vs. "oral") with physiologic and patient function as primary outcome measures after surgery.
详细描述
Evidence-based guidelines on optimal perioperative fluid management have not been established in patients undergoing orthopaedic surgery. Typical intraoperative and post-operative fluid management has been arbitrary without evidence based guidelines established following total joint replacement. The investigators have observed many patients post-operatively with side effects such as fluid overload leading to medical complications requiring either prolonged hospitalization or readmission. Additionally, this overload may lead to wound healing complications secondary to fluid shifts which may be devastating in this patient population. Recent randomized trials in major abdominal surgery suggest that large amounts of IV fluid may increase morbidity and hospital stay. Additionally, this increase fluid may be detrimental in patients with anastomosis leading to failure and/or complications in this patient population. The investigators have defined to specific groups of interest to study in this patient population with regards to fluid management. The first group is the "traditional" IV fluid group where the anesthesiologist gives an unspecific amount of fluid intraoperatively and post-operatively the patient gets a set amount of fluid based on "protocol" on the orthopaedic floor (i.e. 75 cc/hour until good oral intake). This is the protocol utilized by most orthopaedic practices throughout the United States. The second group is defined as patients who are given a specific protocol preoperatively to optimize hydration, followed by limited fluids intraoperatively based on physiologic parameters. This study will investigate the effects of two regimens of intraoperative fluid management ("traditional" vs. "oral") with
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Patients between the ages of 18-75 years old undergoing a primary total knee arthroplasty for a diagnosis of degenerative osteoarthritis who do not meet the exclusion criteria listed below
排除标准
- •Volume-dependent cardiac conditions:
- •Aortic stenosis
- •Pulmonary valve stenosis
- •Subaortic stenosis
- •Severe Aortic Insufficiency
- •Chronic systolic heart failure
- •Eisenmeinger Syndrome
- •Severe pulmonary HTN
- •Chronic or paroxysmal dysrhythmias
- •Pre-operative electrolyte abnormalities
- •Abnormalities of the HPA (hypothalamic-pituitary axis)
- •Stage 3 Chronic Kidney Disease (or worse)
- •Patients taking angiotensin receptor blockers (ARB)
- •Patients with uncontrolled diabetes mellitus (patient with A1C of 7+ or on insulin)
- •Patients whose BMI is > 35 38 or < 19
- •Current use of long acting narcotic medication or 3 or more months of daily short acting narcotic medication
- •Patients at risk for electrolyte abnormalities, dehydration or intra-operative hypotension. (patients taking angiotensin receptor blockers, ACE inhibitors (48 hours prior to surgery) and Diuretics)
- •Patients with severe, untreated or uncontrolled GERD.
- •Patients that cannot receive spinal anesthesia (e.g. patient with back fusions)
- •Pre-Operative Anemia
结局指标
主要结局
Body Weight
时间窗: Change is patients weight from baseline at pre op to two weeks post op.
Patient Weight will be monitored
次要结局
- Knee Range of Motion(Post Op Day 1, 2 Weeks and 6 Weeks Post Op)
- Number of Participants With Thromboembolic Disease(Post Opeartive until the 6 week follow up appointment)
- Number of Patients Re-admitted Post TKA(up to 6 weeks post op)
- Postoperative Pain Assessment Using Visual Analog Scale(Every 4 hours, averaged daily, reported at Post op day 1 and 2 (while in the hospital), weeks 1, 2, 3, and 4 (3 times a day))
- Patient Reported Outcomes - Knee Society Score(KSS)(pre-operatively as well as at their 2 week and 6 week follow up appointments)
- Leg Anthropometric (Girth) Measurements(Post op Day 1, 2 weeks and 6 weeks Post Op)
- Quadriceps Strength Measure With a Handheld Dynamometer(Post Op day 1, 2 Week and 6 Week Post OP)
- Veterans Rand -12(2 week and 6 week follow up appointments)
- Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS)(pre-operatively as well as at their 2 week and 6 week follow up appointments)
- Total IV Fluids Received(Duration of IV intervention, up to 2 days)
- Number of Participants With Requiring Transfusions(intra operative, Post Op Day #1 or #2)
- Number of Participants With Off Wound Complications Post Operative(Up to 6 weeks Post OP)
- Time up and GO(preoperative appointment and once again at their 2 and 6 weeks postoperatively)
- 30 Second STS Test(preoperative appointment and once again at their 2 and 6 weeks postoperatively)
- Length of the Hospitalization(Daily up to 2 days while hospitalized)
- Bioimpedence(pre-op visit, Post Op Day #1 as well as their 2 week and 6 week visit)
- PONV (Post-operative Nausea and Vomiting)(Daily up to 2 days while hospitalized)
研究者
Jason Jennings
Principal Investigator
Colorado Joint Replacement