Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure

September 1, 2016 updated by: The Center for Clinical Research, Winston-Salem, NC

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: clonidine
Intrathecal Clonidine
Other Names:
  • catapres

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Pressure After Intrathecal Injection of Clonidine.
Time Frame: 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.
Baseline, Every 10 Minutes for first hour after clonidine injection, and every 15 minutes after first hour, until 4 hours after clonidine injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Likert Scale Pain Rating
Time Frame: Pre-dose and 1 hour post injection.
Likert scale is 11 point digital pain rating system that asks subjects to rate their pain from 0 to 10. Rating of 0 means no pain at all, and in increasing order, 10 would mean worst pain imaginable/ unbearable pain.
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
Time Frame: Before clonidine injection (Baseline), and at 1 hour after clonidine injection.
Subjects were asked to rate severity of two of the most common side effects of clonidine, sedation and sensation of dry mouth, at pre and post (1 hour after) intrathecal administration of clonidine. The mean changes between pre and post injection VAS ratings of sedation and sensation of dry mouth are reported below. The VAS scale ranges from 1 to 10 cm, with higher values indicating higher level of sedation and higher level of dry mouth.
Before clonidine injection (Baseline), and at 1 hour after clonidine injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Center for Clinical Research, Winston-Salem, NC

Collaborators

Medtronic

Investigators

  • Principal Investigator: Richard L. Rauck, MD, Owner

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 15, 2011

First Posted (Estimate)

February 16, 2011

Study Record Updates

Last Update Posted (Estimate)

October 19, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1461 Clonidine
  • 1461 (Other Identifier: CSL Behring)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

no individual's data will be shared with anyone other than the members of the study staff, and the confidentiality will be maintained in accordance with HIPAA rules.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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