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

Intubation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00125398
• Other study ID #: 3000-0413
• Secondary ID: GPI 3000-0413Sed
• Status: Completed
• Phase: Phase 2
• First received: July 28, 2005
• Last updated: November 6, 2008
• Start date: July 2005
• Est. completion date: May 2007

Study information

• Verified date: November 2008
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubation
• Postoperative Sedation
• Respiration, Artificial

Intervention

Drug:
• AQUAVAN (fospropofol disodium; GPI 15715 )

Locations

Country	Name	City	State
United States	Central Maine Pulmonary Associates	Auburn	Maine
United States	Boston Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Cooper University Hospital	Camden	New Jersey
United States	Department of Veterans Affairs, North Texas Health Care System	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Iowa Hospital and Clinics	Iowa City	Iowa
United States	Jackson Memorial Hospital	Miami	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	New York University School of Medicine	New York	New York
United States	Oklahoma University Medical Center	Oklahoma City	Oklahoma
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois
United States	St. Mary's Hospital	Rogers	Arizona
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of infusions
Secondary	Percentage of patients requiring rescue medications
Secondary	Evaluation of the onset of effect
Secondary	Evaluation of satisfaction with sedation
Secondary	Determination of pharmacokinetic (PK) levels of GPI 15715 in blood