- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00125398
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
Study Overview
Status
Intervention / Treatment
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
Enrollment
Phase
- Phase 2
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Require 2 to 8 hours of intubation and mechanical ventilation following elective surgery
- American Society of Anesthesiologists (ASA) status of I-IV
Exclusion Criteria:
- Requires emergency agency
- Requires neuromuscular blockers during sedation
- Requires use of epidural drug administration during sedation
Study Plan
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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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.
Clinical Trials on Intubation
-
Spanish Network for Research in Infectious DiseasesCompletedIntubation | Intubation Complication | Intubation; Difficult or FailedSpain
-
University Hospital, Clermont-FerrandSociété Française d'Anesthésie-Réanimation (SFAR)Not yet recruitingEndotracheal Intubation | Intubation Complication | Intubation; Difficult or Failed
-
Emory UniversityTerminatedAirway Morbidity | Intubation Complication | Anesthesia Intubation Complication | Tracheal Intubation Morbidity | Failed or Difficult Intubation, SequelaUnited States
-
Catharina Ziekenhuis EindhovenCompletedAnesthesia Intubation Complication | Intubation; Difficult | Failed or Difficult Intubation | Failed or Difficult Intubation, Initial EncounterNetherlands
-
Children's Hospital of PhiladelphiaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedIntubation Complication | Intubation;Difficult | Failed or Difficult Intubation, SequelaUnited States, Canada, Singapore
-
Children's Hospital of PhiladelphiaAgency for Healthcare Research and Quality (AHRQ)RecruitingIntubation Complication | Intubation; Difficult | Failed or Difficult Intubation, SequelaUnited States, Canada, Japan, Italy, New Zealand, Singapore, Australia, Austria, Germany, India, United Kingdom
-
Kaohsiung Medical University Chung-Ho Memorial...CompletedIntubation, Nasotracheal IntubationTaiwan
-
Kaohsiung Medical University Chung-Ho Memorial...CompletedIntubation Complication | Intubation, DifficultTaiwan
-
Huazhong University of Science and TechnologyCompletedIntubation Complication | Intubation; DifficultChina
-
University at BuffaloTerminatedIntubation Complication | Intubation;DifficultUnited States
Clinical Trials on AQUAVAN (fospropofol disodium; GPI 15715 )
-
Eisai Inc.PPDCompletedCoronary Artery Bypass Surgery | Ischemic Coronary Artery Disease
-
Eisai Inc.CompletedAnesthesia | BronchoscopyUnited States
-
Eisai Inc.CompletedProcedural SedationUnited States
-
West China HospitalCompleted
-
Eisai Inc.Omnicare Clinical Research; MDS Pharma Services; Bio Analytical Research Corporation and other collaboratorsCompletedColonoscopy | Colon Polyps
-
Eisai Inc.CompletedColonic Polyps | ColonoscopyUnited States
-
Eisai Inc.PPD; Covance; Quest Pharmaceutical ServicesTerminated
-
Eisai Inc.PPD; Covance; Quest Pharmaceutical ServicesTerminated
-
Eisai Inc.PPD; MDS Pharma Services; Bio Analytical Research Corporation; Coghlan Group (Plasma...CompletedColonoscopy | Colon Polyps