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

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00125398
First received: July 28, 2005
Last updated: November 6, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Postoperative Sedation
Intubation
Respiration, Artificial
Drug: AQUAVAN (fospropofol disodium; GPI 15715 )
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Safety and tolerability of infusions

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 60
Study Start Date: July 2005
Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125398

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

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00125398     History of Changes
Other Study ID Numbers: 3000-0413, GPI 3000-0413, Sedation in an ICU Setting
Study First Received: July 28, 2005
Last Updated: November 6, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
AQUAVAN
GPI 15715
ICU
Sedation

Additional relevant MeSH terms:
Fospropofol
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014