SedationPhase 4NCT00158873
Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects
A Phase 4 study testing midazolam, lorazepam and fentanyl in people with Sedation, run by GlaxoSmithKline at 15 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation
- What is being tested?
- midazolam, lorazepam and fentanyl
- How many people
- 224 participants
- Where
- 15 sitesNetherlands
- Study dates
- Sep 2004to not given
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU patients with an expected duration of mechanical ventilation for 2 to 3 days and requiring analgesia and sedation.
Who cannot join
- ICU patients resuscitated in the previous 24 hours, neurotrauma or expecting major surgery, not likely to survive of with limit care status.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Netherlands15 sites
GSK Investigational Site
's-Hertogenbosch, 5211 RW
GSK Investigational Site
Alkmaar, 1815 JD
GSK Investigational Site
Amsterdam, 1081 HV
GSK Investigational Site
Apeldoorn, 7334 DZ
GSK Investigational Site
Dordrecht, 3318 AT
GSK Investigational Site
Ede, 6716 RP
GSK Investigational Site
Eindhoven, 5623 EJ
GSK Investigational Site
Haarlem, 2035 RC
GSK Investigational Site
Helmond, 5707 HA
GSK Investigational Site
Hengelo, 7555 DL
GSK Investigational Site
Rotterdam, 3015 GJ
GSK Investigational Site
The Hague, 2512 VA
GSK Investigational Site
Tiel, 4002 WP
GSK Investigational Site
Venlo, 5912 BL
GSK Investigational Site
Zwolle, 8011 JW
About this study
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
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.
- Conditions
- Sedation
- Being tested
- midazolam, lorazepam, fentanyl, morphine, remifentanil
- Keywords
- ICU mechanical ventilation analgesia sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolamDrug
lorazepamDrug
fentanylDrug
morphineDrug
remifentanilDrug
propofolDrug
Also called midazolam, lorazepam, fentanyl, morphine
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Outcome: Duration of time on mechanical ventilation
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2004
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 SedationStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 224 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158873
- Sponsor's protocol ID
- 101653
- Status last verified
- Oct 2008
- First submitted
- 8 Sep 2005
- Last updated
- 16 Oct 2008
- Results posted
- No
Publications
Al MJ, Hakkaart L, Tan SS, Bakker J. Cost-consequence analysis of remifentanil-based analgo-sedation vs. conventional analgesia and sedation for patients on mechanical ventilation in the Netherlands. Crit Care. 2010;14(6):R195. doi: 10.1186/cc9313. Epub 2010 Nov 1.
PubMed 21040558
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00158873
- Acronym / sponsor ID
- 101653
- Conditions
- Sedation
- Keywords
- ICU mechanical ventilation analgesia sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- First posted
- 12 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ICU patients with an expected duration of mechanical ventilation for 2 to 3 days and requiring analgesia and sedation.
Key exclusion criteria (1 listed)
- ICU patients resuscitated in the previous 24 hours, neurotrauma or expecting major surgery, not likely to survive of with limit care status.
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 |
|---|---|---|
| midazolam | Drug | – |
| lorazepam | Drug | – |
| fentanyl | Drug | – |
| morphine | Drug | – |
| remifentanil | Drug | – |
| propofolAlso: midazolam, lorazepam, fentanyl, morphine | Drug | – |
Primary outcome
Health Outcome: Duration of time on mechanical ventilation
1 secondary outcome
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
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 16 Oct 2008.
- Derived from this study: PubMed 21040558Al MJ, Hakkaart L, Tan SS, Bakker J. Cost-consequence analysis of remifentanil-based analgo-sedation vs. conventional analgesia and sedation for patients on mechanical ventilation in the Netherlands. Crit Care. 2010;14(6):R195. doi: 10.1186/cc9313. Epub 2010 Nov 1.
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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.
GSK Clinical Trials, MD study director
GlaxoSmithKline
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing midazolam, lorazepam and fentanyl in people with Sedation, run by GlaxoSmithKline at 15 sites in Netherlands.
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 1 inclusion and 1 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 16 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Health Outcome: Duration of time on mechanical ventilation. 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 NCT00158873, 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 16 Oct 2008.