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| ID | Type | Description | Link |
|---|---|---|---|
| GPI 3000-0413 | |||
| Sedation in an ICU Setting |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AQUAVAN (fospropofol disodium; GPI 15715 ) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of infusions |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients requiring rescue medications | ||
| Evaluation of the onset of effect | ||
| Evaluation of satisfaction with sedation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Jones, MD, PharmD | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Mary's Hospital | Rogers | Arizona | 72756 | United States | ||
| Jackson Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21596879 | Derived | 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. |
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| Determination of pharmacokinetic (PK) levels of GPI 15715 in blood |
| Miami |
| Florida |
| 33136 |
| United States |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | United States |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | United States |
| Central Maine Pulmonary Associates | Auburn | Maine | 04210 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| New York University School of Medicine | New York | New York | 10016 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Department of Veterans Affairs, North Texas Health Care System | Dallas | Texas | 75216 | United States |
| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C472965 | fospropofol |
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