Splanchnic Nerve Block for Acute Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Central Venous Pressure
研究概览
简要总结
Patients admitted for acute heart failure and undergoing right heart catheterization will be enrolled in this study. Subjects will undergo catheterization of the heart to obtain central cardiac pressure and other cardiac hemodynamic parameters. Subsequently, the subject will undergo a regional nerve block of the splanchnic nerves. Patients will remain in the catheterization lab for the duration of anesthetic block and will be continuously hemodynamically monitored.
This study will be a prospective, uncontrolled clinical trial. The study will not be controlled as invasive monitoring of hemodynamics will be performed, allowing clear demonstration of a cause-effect relationship. The goal of the study is to provide proof of concept.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of heart failure (HF)
- •Prior admissions for decompensated HF
- •Symptomatic with dyspnea with clinical, radiographic or echocardiographic signs of fluid overload
- •On a stable HF drug regimen prior to admission
- •Anticipated hospital stay of at least 2 nights following catheterization procedure
排除标准
- •Ongoing treatment with oral anticoagulation other than aspirin
- •Immunosuppressive medications for solid organ transplant
- •Acute MI (STEMI or NSTEMI) within 7 days
- •Evidence of cardiogenic shock within 48 hours
- •Systolic blood pressure < 90 mmHg or >180 mmHg
- •Restrictive or constrictive cardiomyopathy
- •Chronic kidney disease stage 3 or higher due to primary renal pathology
- •Pregnancy
研究组 & 干预措施
Regional nerve anesthesia
Regional nerve anesthesia of splanchnic nerve
干预措施: splanchnic nerve anesthesia with a local anesthetic (Procedure)
Regional nerve anesthesia
Regional nerve anesthesia of splanchnic nerve
干预措施: regional nerve block with a local anesthetic (Lidocaine) (Drug)
结局指标
主要结局
Central Venous Pressure
时间窗: Baseline, 90 minutes
Pulmonary Arterial Mean Pressure
时间窗: baseline, 30 minutes
Pulmonary Capillary Wedge Pressure
时间窗: baseline, 30 minutes
次要结局
- Cardiac Index(baseline, 30 minutes)
- Right Ventricular Diameter(Baseline, 30 mins)
- Change in Creatinine Level(Baseline; 90 minutes)
- Dyspnea as Measured on Likert Scale(15, 30, 45, 60, 75, 90 minutes; 24 hours)
- Change in Clinical Symptoms, as Measured by 6 Minute Walk Test(Baseline, 90 minutes, 24 hours)
- Pulmonary Artery Systolic Pressure(Baseline, 30 minutes)
- N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Level(Baseline; 90 minutes)
- Ejection Fraction (LVEF)(Baseline, 90 minutes)
- Urine Output Measured in ml Over 3 Hours(Baseline, post-procedure (0-3 hours))
- Left Ventricular Diameter(Baseline, 30 mins)
- Change in Blood Urea Nitrogen (BUN)(Baseline; 90 minutes)