Use of Transdermal Clonidine in Trauma Patients

NCT01139996 | Terminated Phase 4 Results DMC

• 1 other identifier: MHUMC-2010-04-02
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study will attempt to learn how to better treat trauma patients with delirium who are on a breathing machine. Delirium, also known as acute, temporary brain dysfunction, is a common reason why ventilated patients can not be weaned from the breathing machine even though their lungs may be healthy enough to breathe without the machine. The study hopes to show that by decreasing the patient's delirium it will lead to quicker weaning from the breathing machine and possibly a quicker overall recovery as well. Patients enrolled in this study will be treated with Clonidine or placebo. Clonidine is a drug that produces significant calming effects, decreases anxiety, and reduces pain, but with a lower incidence of delirium than other medications used in the ICU for this purpose. Clonidine is not approved by the Federal Food and Drug Administration for treatment of delirium, but is commonly used for this purpose.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Duration of Mechanical Ventilation Following Administration of the First Dose of Clonidine or Placebo

  data were not collected

  2 or more years

Secondary Outcomes (3)

• Incidence and Duration in Hours of Delirium Currently Used

  2 or more years

• Time to Pass First SBT Following Administration of the First Dose of Clonidine or Placebo

  2 or more years

• Mean Incidence and Duration of Delirium

  2 or more years

Study Arms (2)

Transdermal Clonidine/Oral Clonidine

EXPERIMENTAL

An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours

Drug: Clonidine

Comparator

PLACEBO COMPARATOR

Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet

Drug: Placebo

Interventions

Clonidine DRUG

An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours

Transdermal Clonidine/Oral Clonidine

Placebo DRUG

A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet

Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ventilated male or female trauma patient 18 years of age or older admitted to the ICU \>24 hours
• Patient must meet minimal medical criteria for potential extubation (meet criteria for being placed on spontaneous breathing trials per established MUMC SBT protocol)
• Patients must exhibit delirium as assessed by the CAM-ICU assessment tool
• Patient must be declared stable from a neurologic, respiratory and cardiovascular standpoint to receive clonidine by the attending MD
• Consent must be obtained prior to any study procedures

You may not qualify if:

• Patient \< 18 years old
• Bradycardia (HR \< 60)
• Presence of active pacemaker
• Hypotensive (\<90/60)or active treatment of hypotension with vasoactive medications
• Patient actively being treated with Clonidine or dexmedetomidine
• Presence of allergy to Clonidine
• Pregnancy

Sponsors & Collaborators

• Memorial Health University Medical Center: lead

Study Sites (1)

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

MeSH Terms

Conditions

Delirium

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Imran Siddiqui, MD
• Organization: Memorial University Medical Center

research2@memorialhealth.com

912-350-8707

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 9, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Locations

US (1)