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

NCT ID: NCT00125398

Last Updated: 2008-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2007-05-31

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.

Conditions

Postoperative Sedation; Intubation; Respiration, Artificial

Keywords

AQUAVAN; GPI 15715; ICU; Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

AQUAVAN (fospropofol disodium; GPI 15715 )

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

James Jones, MD, PharmD

Role: STUDY_DIRECTOR

Eisai Inc.

Locations

St. Mary's Hospital

Rogers, Arizona, United States

Jackson Memorial Hospital

Miami, Florida, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Central Maine Pulmonary Associates

Auburn, Maine, United States

Boston Medical Center

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Cooper University Hospital

Camden, New Jersey, United States

Long Island Jewish Medical Center

New Hyde Park, New York, United States

New York University School of Medicine

New York, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Oklahoma University Medical Center

Oklahoma City, Oklahoma, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Department of Veterans Affairs, North Texas Health Care System

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21596879 (View on PubMed)

Other Identifiers

GPI 3000-0413

Identifier Type: -

Identifier Source: secondary_id

Sedation in an ICU Setting

Identifier Type: -

Identifier Source: secondary_id

3000-0413

Identifier Type: -

Identifier Source: org_study_id