Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects
Overview[ - collapse ][ - ]
| Purpose | The study will evaluate the pharmaco-economic consequences of the use of a remifentanil based regimen compared with a conventional sedative based regimen in terms of duration of mechanical ventilation, length of stay in ICU, difference in extubation time and use of concomitant sedative agents. |
|---|---|
| Condition | Sedation |
| Intervention | Drug: midazolam Drug: lorazepam Drug: fentanyl Drug: morphine Drug: remifentanil Drug: propofol |
| Phase | Phase 4 |
| Sponsor | GlaxoSmithKline |
| Responsible Party | GlaxoSmithKline |
| ClinicalTrials.gov Identifier | NCT00158873 |
| First Received | September 8, 2005 |
| Last Updated | October 15, 2008 |
| Last verified | October 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 8, 2005 |
|---|---|
| Last Updated Date | October 15, 2008 |
| Start Date | September 2004 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Health Outcome: Duration of time on mechanical ventilation |
| Current Secondary Outcome Measures | Health Outcome: length of stay in ICU, in hospital, requirement of opioid and sedative agents, duration of extubation process. Safety: haemodynamics and adverse events. Efficacy: sedation and pain scores |
Descriptive Information[ + expand ][ + ]
| Brief Title | Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects |
|---|---|
| Official Title | A Centre-Randomized, Open-Label, Cross-Over Study to Compare the Pharmaco-Economic Consequences of an Ultiva (Remifentanil Hydrochloride) Based Regimen With Conventional Sedative Based Regimens in ICU Subjects Requiring Short-Term Mechanical Ventilation With Analgesia and Sedation |
| Brief Summary | The study will evaluate the pharmaco-economic consequences of the use of a remifentanil based regimen compared with a conventional sedative based regimen in terms of duration of mechanical ventilation, length of stay in ICU, difference in extubation time and use of concomitant sedative agents. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Sedation |
| Intervention | Drug: midazolam Drug: lorazepam Drug: fentanyl Drug: morphine Drug: remifentanil Drug: propofol Other Names:
|
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 224 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - ICU patients with an expected duration of mechanical ventilation for 2 to 3 days and requiring analgesia and sedation. Exclusion criteria: - ICU patients resuscitated in the previous 24 hours, neurotrauma or expecting major surgery, not likely to survive of with limit care status. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Netherlands |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00158873 |
|---|---|
| Other Study ID Numbers | 101653 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | GlaxoSmithKline |
| Study Sponsor | GlaxoSmithKline |
| Collaborators | Not Provided |
| Investigators | Study Director: GSK Clinical Trials, MD GlaxoSmithKline |
| Verification Date | October 2008 |
Locations[ + expand ][ + ]
| GSK Investigational Site | Alkmaar, Netherlands, 1815 JD |
|---|---|
| GSK Investigational Site | Amsterdam, Netherlands, 1081 HV |
| GSK Investigational Site | Apeldoorn, Netherlands, 7334 DZ |
| GSK Investigational Site | Den Bosch, Netherlands, 5211 RW |
| GSK Investigational Site | Den Haag, Netherlands, 2512 VA |
| GSK Investigational Site | Dordrecht, Netherlands, 3318 AT |
| GSK Investigational Site | EDE, Netherlands, 6716 RP |
| GSK Investigational Site | Eindhoven, Netherlands, 5623 EJ |
| GSK Investigational Site | Haarlem, Netherlands, 2035 RC |
| GSK Investigational Site | Helmond, Netherlands, 5707 HA |
| GSK Investigational Site | Hengelo, Netherlands, 7555 DL |
| GSK Investigational Site | Rotterdam, Netherlands, 3015 GJ |
| GSK Investigational Site | Tiel, Netherlands, 4002 WP |
| GSK Investigational Site | Venlo, Netherlands, 5912 BL |
| GSK Investigational Site | Zwolle, Netherlands, 8011 JW |