GPI 15715 For Sedation in the Intensive Care Unit (ICU) Setting

November 6, 2008 updated by: Eisai Inc.

A Phase II, Randomized, Open-Label Study to Examine the Safety and Efficacy of GPI 15715 for Sedation of Patients Requiring Intubation and Mechanical Ventilation in the Intensive Care Unit Setting

Patients who are in the intensive care unit after surgery and require mechanical breathing support (intubation and ventilation) usually require sedation to avoid agitation and excessive stress responses. Short-acting sedatives such as midazolam and propofol are the drugs typically used for this. Propofol provides for fast sedation and fast recovery from sedation. Midazolam is slower to sedation and slower for recovery, but may provide some advantages over propofol, such as a lower incidence of hypotension (low blood pressure). This study will look at propofol compared to a product with fast sedation and recovery like that of propofol but with less of a chance for hypotension like with midazolam. Patients will be treated with the product for up to 8 hours and then will be monitored for 8 hours following treatment.

Study Overview

Detailed Description

Patients who are intubated and ventilated and will require up to 8 hours of sedation in the ICU are eligible for participation in this study. Patients will be randomized to receive 1 of 3 treatments. One treatment is standard of care, a propofol infusion. The other two treatment arms are infusions of GPI 15715 (AQUAVAN), one with a bolus and one without.

Patients will be treated for up to 8 hours and monitored for eight hours post treatment. If there are signs of agitation during the up to 8 hour treatment period, the infusion of the sedative medicine will be increased according to protocol.

Blood samples will be obtained periodically during the course of the study for safety evaluation and pharmacokinetic assessments. When the patient is ready for extubation or the end of the 8 hour study period has been reached, the infusion of the sedative agent will be discontinued and the patient will be monitored for 8 hours post treatment.

Guilford Pharmaceuticals was acquired by MGI PHARMA on October 3, 2005.

Study Type

Interventional

Enrollment

60

Phase

  • Phase 2

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

    • Arizona
      • Rogers, Arizona, United States, 72756
        • St. Mary's Hospital
    • Florida
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital and Clinics
    • Maine
      • Auburn, Maine, United States, 04210
        • Central Maine Pulmonary Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10016
        • New York University School Of Medicine
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75216
        • Department of Veterans Affairs, North Texas Health Care System

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Require 2 to 8 hours of intubation and mechanical ventilation following elective surgery
  2. American Society of Anesthesiologists (ASA) status of I-IV

Exclusion Criteria:

  1. Requires emergency agency
  2. Requires neuromuscular blockers during sedation
  3. Requires use of epidural drug administration during sedation

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety and tolerability of infusions

Secondary Outcome Measures

Outcome Measure
Percentage of patients requiring rescue medications
Evaluation of the onset of effect
Evaluation of satisfaction with sedation
Determination of pharmacokinetic (PK) levels of GPI 15715 in blood

Collaborators and Investigators

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

Sponsor

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.

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

July 1, 2005

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

July 28, 2005

First Submitted That Met QC Criteria

July 28, 2005

First Posted (Estimate)

August 1, 2005

Study Record Updates

Last Update Posted (Estimate)

November 7, 2008

Last Update Submitted That Met QC Criteria

November 6, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • 3000-0413
  • GPI 3000-0413
  • Sedation in an ICU Setting

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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