Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Decrease in Mean Arterial Blood Pressure of 15 mm Hg [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]10 subjects with a decrease in Mean Arterial Blood Pressure of 15 mm Hg which is the minimal decrease that will be used to determine clinical significance.
- Intrathecal Clonidine Response Characterization #1 [ Time Frame: Pre-dose and 1 hour intervals ] [ Designated as safety issue: No ]
- One-minute isometric grip challenge
- Intrathecal Clonidine Response Characterization #2 [ Time Frame: Pre-dose and 1 hour intervals ] [ Designated as safety issue: No ]
- Numeric Pain Score on 11-point Likert Scale
- Intrathecal Clonidine Response Characterization #3 [ Time Frame: Pre-dose and 1 hour intervals ] [ Designated as safety issue: No ]
- Level of sedation and dry mouth on 10 cm visual analog scale (VAS)
|Study Start Date:||February 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: 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.
Other Name: catapres
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297335
|Principal Investigator:||Richard L. Rauck, MD||Owner|