GPI 15715 For Sedation in the Intensive Care Unit (ICU) Setting
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
3 other identifiers
interventional
60
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2005
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 28, 2005
CompletedFirst Posted
Study publicly available on registry
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedNovember 7, 2008
November 1, 2008
July 28, 2005
November 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of infusions
Secondary Outcomes (4)
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
Interventions
Eligibility Criteria
You may qualify if:
- Require 2 to 8 hours of intubation and mechanical ventilation following elective surgery
- American Society of Anesthesiologists (ASA) status of I-IV
You may not qualify if:
- Requires emergency agency
- Requires neuromuscular blockers during sedation
- Requires use of epidural drug administration during sedation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (17)
St. Mary's Hospital
Rogers, Arizona, 72756, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242, United States
Central Maine Pulmonary Associates
Auburn, Maine, 04210, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
New York University School of Medicine
New York, New York, 10016, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Department of Veterans Affairs, North Texas Health Care System
Dallas, Texas, 75216, United States
Related Publications (1)
Candiotti KA, Gan TJ, Young C, Bekker A, Sum-Ping ST, Kahn R, Lebowitz P, Littman JJ. A randomized, open-label study of the safety and tolerability of fospropofol for patients requiring intubation and mechanical ventilation in the intensive care unit. Anesth Analg. 2011 Sep;113(3):550-6. doi: 10.1213/ANE.0b013e31821d7faf. Epub 2011 May 19.
PMID: 21596879DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James Jones, MD, PharmD
Eisai Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 28, 2005
First Posted
August 1, 2005
Study Start
July 1, 2005
Study Completion
May 1, 2007
Last Updated
November 7, 2008
Record last verified: 2008-11