A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Heart Surgery

March 20, 2017 updated by: Hospira, now a wholly owned subsidiary of Pfizer

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel, Multicenter Study Evaluating the Efficacy and Safety of Dexmedetomidine in the Prevention of Postoperative Delirium in Subjects Undergoing Heart Surgery With Cardiopulmonary Bypass

The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing heart valve surgery with or without coronary artery bypass surgery (CABG) using cardiopulmonary bypass (CPB).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Postoperative delirium is an acute decline in cognition and attention which is usually transient but when delirium persists, it can impact cognitive function, morbidity and mortality. Currently, there are no drugs to prevent delirium but dexmedetomidine has the potential to meet this unmet medical need.

Dexmedetomidine is currently approved for use for 24 hours in patients on ventilators in the Intensive Care Unit(ICU). This study is to determine whether or not dexmedetomidine can prevent delirium after heart surgery. Study participation will last from randomization prior to surgery, to 3 days after surgery. Dexmedetomidine will be given through an intravenous catheter beginning at sternal closure and continue throughout the stay in the ICU. Delirium will be assessed prior to surgery and for 72 hours after surgery. This assessment will consist of questions that will evaluate memory and thought process. Thirty days after surgery, questions will be asked regarding the patients feelings about their health status and hospital billing information will be collected.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University
    • Maryland
      • Towson, Maryland, United States, 21204-7582
        • Midatlantic Cardiovascular Associates
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Cardiovascular and Thoracic Surgical Associates
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43214
        • Cardiothoracic and Vascular Surgical Specialists
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Houston, Texas, United States, 77030
        • Texas Heart Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22908-0710
        • University of Virginia Health System, Dept. of Anesthesiology
      • Norfolf, Virginia, United States, 23507
        • Santara Norfolk General Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult (≥18 years old) male or female who will undergo elective heart valve surgery (with or without CABG and using CPB) with general anesthesia and require an overnight stay in the ICU following surgery.

  • If female, subject is non-lactating and is either:

    1. Not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy.
    2. Of childbearing potential but is not pregnant at time of baseline and is practicing one of the following methods of birth control: oral or parenteral contraceptives, doublebarrier method, vasectomized partner, or abstinence from sexual intercourse.
  • Subject is American Society of Anesthesiologists (ASA) Physical Status II, III, or IV.
  • Subject (or subject's legally authorized representative) has voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB).

Exclusion Criteria:

  • Cognitive function level by Mini Mental State Exam (MMSE) of ≤ 20 at screening.
  • Subject has a positive CAM-ICU result for delirium at Screening.
  • Subject requires chronic anti-psychotic therapy.
  • Subject has participated in a trial with any experimental drug or experimental implantable device within 30 days prior to the study drug administration, or has ever been enrolled in this study.
  • Subject is known to be in liver failure.
  • Subject has an anticipated potential for increased intracranial pressure or an uncontrolled seizure disorder or known psychiatric illness that could confound a normal response during study assessment.
  • Subject has acute myocardial infarction, HR <50 bpm, SBP <90 mmHg, is hemodynamically unstable requiring systemic inotropic drugs or intra-aortic counterpulsation balloon pump within the last 72 hours.
  • Subject is anticipated to require hypothermic circulatory arrest during this surgical procedure.
  • Subject has received treatment with a α2-agonist or antagonist (within 14 days of study entry).
  • Subject for whom opiates, propofol, Dexmedetomidine or other α2-agonists are contraindicated.
  • Subject has, per the investigator's judgment, a known or suspected physical or psychological dependence on an abused drug, other than alcohol.
  • Subject has any condition or factor which, in the Investigator's opinion, might increase the risk to the subject.
  • Subject is not expected to live more than 60 days.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine
Drug: Dexmedetomidine
Placebo Comparator: Placebo (PBO)
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects who experienced any postoperative delirium up to 3 days following surgery
Time Frame: Postoperative period (3-days): Twice daily (6:00 - 9:00 AM and 5:00 - 8:00 PM)
The presence of postoperative delirium will be determined by the Confusion Assessment Method (CAM-ICU)
Postoperative period (3-days): Twice daily (6:00 - 9:00 AM and 5:00 - 8:00 PM)

Secondary Outcome Measures

Outcome Measure
Time Frame
Daily percentage of subjects who experienced postoperative delirium
Time Frame: At each day during 3-day postoperative delirium
At each day during 3-day postoperative delirium
Duration of postoperative delirium as determined by CAM-ICU up to 3 days post surgery
Time Frame: Up to 3 days post surgery
Up to 3 days post surgery
Postoperative use of all analgesics
Time Frame: During postextubation period (Approximately 3 days)
During postextubation period (Approximately 3 days)
Time to extubation after arrival in ICU
Time Frame: From the time of ICU arrival to the time of ICU discharge (Approximately 3 days)
From the time of ICU arrival to the time of ICU discharge (Approximately 3 days)
Length of ICU stay
Time Frame: From the time of ICU arrival to the time of ICU discharge (Approximately 3 days)
From the time of ICU arrival to the time of ICU discharge (Approximately 3 days)

Collaborators and Investigators

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

Sponsor

Hospira, now a wholly owned subsidiary of Pfizer

Investigators

  • Study Director: Paula Bokesch, MD, Hospira, now a wholly owned subsidiary of Pfizer

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

April 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

April 23, 2007

First Submitted That Met QC Criteria

April 23, 2007

First Posted (Estimate)

April 24, 2007

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEX-06-06

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.

Clinical Trials on Delirium

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe