Postoperative SedationPhase 2NCT00125398
GPI 15715 For Sedation in the Intensive Care Unit (ICU) Setting
A Phase 2 study testing AQUAVAN (fospropofol disodium; GPI 15715 ) in people with Postoperative Sedation and Intubation, run by Eisai Inc. at 17 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Sedation, Intubation, Respiration, Artificial
- What is being tested?
- AQUAVAN (fospropofol disodium; GPI 15715 )
- How many people
- 60 participants
- Where
- 17 sitesUnited States
- Study dates
- Jul 2005to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Require 2 to 8 hours of intubation and mechanical ventilation following elective surgery
- American Society of Anesthesiologists (ASA) status of I-IV
Who cannot join
- Requires emergency agency
- Requires neuromuscular blockers during sedation
- Requires use of epidural drug administration during sedation
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Central Maine Pulmonary Associates
Auburn, Maine, 04210
Boston Medical Center
Boston, Massachusetts, 02118
Cooper University Hospital
Camden, New Jersey, 08103
Department of Veterans Affairs, North Texas Health Care System
Dallas, Texas, 75216
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
Jackson Memorial Hospital
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
New York University School of Medicine
New York, New York, 10016
Mount Sinai School of Medicine
New York, New York, 10029
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
St. Mary's Hospital
Rogers, Arizona, 72756
Montefiore Medical Center
The Bronx, New York, 10467
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
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
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.
Read the 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
- Being tested
- AQUAVAN (fospropofol disodium; GPI 15715 )
- Keywords
- AQUAVAN, GPI 15715, ICU, Sedation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQUAVAN (fospropofol disodium; GPI 15715 )Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of infusions
Secondary outcomes (4)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2005 (estimated)
- Study startJul 2005
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative SedationStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Jones, MD, PharmD, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125398
- Sponsor's protocol ID
- 3000-0413
- Other IDs
- GPI 3000-0413, Sedation in an ICU Setting
- Status last verified
- Nov 2008
- First submitted
- 28 Jul 2005
- Last updated
- 7 Nov 2008
- Results posted
- No
Publications
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.
PubMed 21596879
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00125398
- Acronym / sponsor ID
- 3000-0413
- Conditions
- Postoperative Sedation, Intubation, Respiration, Artificial
- Keywords
- AQUAVAN, GPI 15715, ICU, Sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- May 2007 (actual)
- First posted
- 1 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Require 2 to 8 hours of intubation and mechanical ventilation following elective surgery
- American Society of Anesthesiologists (ASA) status of I-IV
Key exclusion criteria (3 listed)
- Requires emergency agency
- Requires neuromuscular blockers during sedation
- Requires use of epidural drug administration during sedation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AQUAVAN (fospropofol disodium; GPI 15715 ) | Drug | – |
Primary outcome
Safety and tolerability of infusions
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2008.
- Derived from this study: PubMed 21596879Candiotti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Jones, MD, PharmD study director
Eisai Inc.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AQUAVAN (fospropofol disodium; GPI 15715 ) in people with Postoperative Sedation and Intubation, run by Eisai Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of infusions. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00125398, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2008.