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Completed

NCT Number: NCT00125398

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

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.

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Key information

Conditions

Postoperative Sedation Intubation Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiration, Artificial Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Mary's Hospital, Rogers, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AQUAVAN (fospropofol disodium; GPI 15715 )

Drug

Primary outcomes

  1. Safety and tolerability of infusions

Secondary outcomes

  1. Percentage of patients requiring rescue medications

  2. Evaluation of the onset of effect

  3. Evaluation of satisfaction with sedation

  4. Determination of pharmacokinetic (PK) levels of GPI 15715 in blood

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2007
First posted
Aug 1, 2005
Registry last updated
Nov 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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