Trial Outcomes & Findings for Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure (NCT NCT01297335)

Last Updated: 2016-10-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Baseline, Every 10 Minutes for first hour after clonidine injection, and every 15 minutes after first hour, until 4 hours after clonidine injection

Results posted on

2016-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	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. clonidine: Intrathecal Clonidine
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intrathecal Clonidine n=10 Participants All subjects met all inclusion and exclusionary criteria, and we report study subjects' demographic information in following sections.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	57 years STANDARD_DEVIATION 5 • n=93 Participants
Sex: Female, Male Female	8 Participants n=93 Participants
Sex: Female, Male Male	2 Participants n=93 Participants
Race/Ethnicity, Customized African American, Non-hispanic	7 participants n=93 Participants
Race/Ethnicity, Customized White, Non-hispanic	3 participants n=93 Participants
Region of Enrollment United States	10 participants n=93 Participants
Duration of Hypertension Diagnosis	17 years n=93 Participants
Number of active antihypertensive medications 4 active antihypertensive medications	8 participants n=93 Participants
Number of active antihypertensive medications 3 active antihypertensive medications	2 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline, Every 10 Minutes for first hour after clonidine injection, and every 15 minutes after first hour, until 4 hours after clonidine injection

Population: All subjects met inclusion and exclusionary criteria, and was given an intrathecal injection of clonidine. They were followed for changes in blood pressure for 4 hours.

Outcome measures

Outcome measures
Measure	Intrathecal Clonidine n=10 Participants Subject received 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 were delivered. Supine and sitting blood pressures and heart rate were measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.
Change in Blood Pressure After Intrathecal Injection of Clonidine. Change in mean SBP after clonidine injection	79 mm Hg Standard Deviation 28
Change in Blood Pressure After Intrathecal Injection of Clonidine. Change in DBP after clonidine injection	37 mm Hg Standard Deviation 17

SECONDARY outcome

Timeframe: Pre-dose and 1 hour post injection.

Population: All subjects met inclusion and exclusionary criteria, and received intrathecal injection of clonidine. Subjects were asked to rate their baseline pain on Likert scale prior to receiving intrathecal clonidine injection, and 1 hour post intrathecal clonidine 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.

Outcome measures

Outcome measures
Measure	Intrathecal Clonidine n=10 Participants Subject received 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 were delivered. Supine and sitting blood pressures and heart rate were measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.
Likert Scale Pain Rating Pre-injection average Likert score	6.5 units on a scale Standard Deviation 1.9
Likert Scale Pain Rating Post-injection average Likert score	3.6 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: Before clonidine injection (Baseline), and at 1 hour after clonidine injection.

Population: All qualified subjects were given intrathecal clonidine and were asked to rate level of sedation and sensation of dry mouth before clonidine injection (baseline) and 1 hour post injection on VAS scale.

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.

Outcome measures

Outcome measures
Measure	Intrathecal Clonidine n=10 Participants Subject received 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 were delivered. Supine and sitting blood pressures and heart rate were measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.
Changes in Visual Analogue Scale (VAS) Ratings of Sedation and Sensation of Dry Mouth Reported by the Subjects, Pre and 1 Hour Post Injection Change in level of sedation	3.36 cm Standard Deviation 3.66
Changes in Visual Analogue Scale (VAS) Ratings of Sedation and Sensation of Dry Mouth Reported by the Subjects, Pre and 1 Hour Post Injection Change in sensation of dry mouth	3.47 cm Standard Deviation 3.93

Adverse Events

Intrathecal Clonidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Director

The Center for Clinical Research

Phone: 3367656181

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place