Hemodynamic Effect of Intrathecal Clonidine in Hypertensive Subjects: A Pilot Study to Assess Its Effectiveness in Hypertensive Subjects With Poor Blood Pressure Control (Phase II)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 主要终点
- Change in Blood Pressure After Intrathecal Injection of Clonidine.
研究概览
简要总结
The purpose of this study is to determine the acute efficacy of intrathecal clonidine to reduce blood pressure in hypertensive subjects with poor blood pressure control and describe its effects on cardiovascular function.
详细描述
Hypertension occurs commonly, is associated with major morbidity and mortality, and responds poorly to current therapies in a small minority of compliant patients. The goal of this investigator-initiated study is to determine whether intrathecal administration of clonidine reduces blood pressure in hypertensive patients, focusing on a group who often achieve inadequate blood pressure control with multiple drug therapy.
After consent, pts will be screened and if qualified brought into center and intrathecal injection of clonidine given. Patients will be closely monitored for 4 hours, while data is collected.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of Hypertension
- •Stable systolic blood pressure >140 mmHg and < 190 mmHg
- •On 3 or more antihypertensive medications
- •On a diuretic
- •Patients must be able to understand the risks
排除标准
- •Allergy to clonidine
- •Presently on clonidine orally or transdermally
- •Known or suspected correctable causes of secondary hypertension
- •Breast Feeding or Pregnant women
- •Unstable Ischemic Heart Disease
- •Unstable Angina
- •Intracoronary Stent Placement
- •Coronary bypass within last 6 months
- •Myocardial Infarction within last 6 months
- •Congestive Failure
- •Cardiac Arrhythmias
- •Known Cerebral Vascular Disease
- •Renal Disease
- •Evidence of Injection Site Infection
- •Known Bleeding Disorders
- •Hepatic Insufficiency
- •Renal Insufficiency
- •Participation in an investigational drug study within 30 day of enrollment
- •Prohibited Medications:
- •Clonidine
- •Yohimbine
- •Tricyclic Antidepressants
- •Mirtazapine
- •Digitalis
- •Reserpine
- •Guanethidine
- •Non-Steroidal Anti-inflammatory Medication
- •Alcohol or Barbiturates within 48 hours of study procedure
研究组 & 干预措施
Intrathecal Clonidine
Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.
干预措施: clonidine (Drug)
结局指标
主要结局
Change in Blood Pressure After Intrathecal Injection of Clonidine.
时间窗: Baseline, Every 10 Minutes for first hour after clonidine injection, and every 15 minutes after first hour, until 4 hours after clonidine injection
Subjects baseline blood pressure (systolic blood pressure (SBP), and diastolic blood pressure (DBP)), and blood pressures after clonidine injection was compared against baseline to assess efficacy of clonidine in refractory hypertensive subjects. Subject's blood pressure was monitored continuously after intrathecal injection of clonidine until subjects blood pressure nadir and return to pre clonidine injection level. The mean value reported below are the average changes in blood pressure from baseline (pre clonidine injection) in both SBP and DBP during post clonidine injection blood pressure monitoring for 4 hours. Blood pressure measurements were collected every 10 minutes for first hour after injection, and every 15 minutes after the first hour, up to 4 hours were averaged to report the change from baseline.
次要结局
- Likert Scale Pain Rating(Pre-dose and 1 hour post injection.)
- Changes in Visual Analogue Scale (VAS) Ratings of Sedation and Sensation of Dry Mouth Reported by the Subjects, Pre and 1 Hour Post Injection(Before clonidine injection (Baseline), and at 1 hour after clonidine injection.)