Clinical trial NCT00125398: GPI 15715 For Sedation in the Intensive Care Unit (ICU) Setting
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Sedation
Intubation
Respiration, Artificial
Keywords: AQUAVAN
GPI 15715
ICU
Sedation
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Safety and tolerability of infusions
Secondary outcomes:
measure: Percentage of patients requiring rescue medications
measure: Evaluation of the onset of effect
measure: Evaluation of satisfaction with sedation
measure: Determination of pharmacokinetic (PK) levels of GPI 15715 in blood
Other outcomes:
Locations:
city: Rogers
country: United States
facility: St. Mary's Hospital
state: Arizona
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics
state: Iowa
city: Auburn
country: United States
facility: Central Maine Pulmonary Associates
state: Maine
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma University Medical Center
state: Oklahoma
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Department of Veterans Affairs, North Texas Health Care System
state: Texas
Study officials:
affiliation: Eisai Inc.
name: James Jones, MD, PharmD
role: STUDY_DIRECTOR
References:
citation: 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.