An Open Label Trial to Decrease Signs and Symptoms of Orthostatic Hypotension Using Midodrine in Patients With Preserved Cardiac Output (CO) and an Intravenous Fluid Bolus for Patients With Low CO Following Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in Orthostatic Hypotension Questionnaire Score
研究概览
简要总结
Orthostatic hypotension following total hip arthroplasty is known to limit the ability of patients to perform physical therapy (PT) and increase the length of hospital stay and costs. Our goal is to prospectively study the effects of oral midodrine on the signs and symptoms of orthostatic hypotension in 20 patients and the effects of intravenous fluid on the signs of symptoms of orthostatic hypotension in 10 patients. Midodrine will be administered to patients with suspected low SVV, and an intravenous fluid bolus will be administered to patients with low CO. 120 patients will be consented with a view to studying 30 patients who meet the inclusion criteria for orthostatic hypotension. Patients who receive midodrine or the fluid bolus will undergo hemodynamic measurements at 30 min, 1 hr, 2 hrs, 3 hrs, and 4 hrs post-intervention. All patients will undergo measurements for blood pressure, arterial augmentation index, and heart rate at baseline (pre-op; holding area) and the time of first PT attempt. Patients will be monitored up to post-operative day 3. The working hypothesis is that midodrine or fluid therapy will significantly raise the mean arterial blood pressure (MAP) by 5 mmHg+ and/or cause a significant change in the Orthostatic Hypotension Questionnaire (characterized by a two-point improvement in symptom score).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of participating surgeons undergoing unilateral primary total hip arthroplasty
- •Ages 18-90
- •English-speaking
- •If the patients are diagnosed with orthostatic hypotension (fall in SBP of at least 20 mmHg or DBP of at least 10 mmHg within 3 min of assuming a sitting/standing position)
排除标准
- •Body mass index > 40
- •Low ejection fraction (<50%)
- •Clinical diagnosis of congestive heart failure
- •Aortic insufficiency characterized as greater than moderate
- •Severe uncontrolled hypertension
- •Symptomatic bradycardia (HR < 50 bpm and symptoms)
- •Creatinine > 1.2 mg/dl
- •Hepatic insufficiency
- •Severe respiratory disease in which supplemental oxygen is required
- •History of severe urinary retention
- •Use of MAO inhibitors
- •Severe supine hypertension (SBP >= 150 mmHg or DBP >= 90 mmHg)
- •History of visual problems and using fludrocortisone acetate
- •Contraindication for repeated BP measurements
- •Revision THA and additional procedures
- •Clonidine use
研究组 & 干预措施
Midodrine
Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once.
干预措施: Midodrine (Drug)
Intravenous fluid bolus
Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once.
干预措施: Intravenous fluid bolus (Other)
结局指标
主要结局
Change in Orthostatic Hypotension Questionnaire Score
时间窗: From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs)
次要结局
- Length of Stay(Length of the hospital stay (average of 4 days))