Last updated: 11/07/2018 19:48:48
An open label, non-comparator, multi-centre study to assess the safety, efficacy and pharmacokinetics of remifentanil in Intensive Care Unit patients with varying degrees of renal dysfunction requiring analgesia and sedation in association with mechanical ventilation.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open label, non-comparator, multi-centre study to assess the safety, efficacy and pharmacokinetics of remifentanil in Intensive Care Unit patients with varying degrees of renal dysfunction requiring analgesia and sedation in association with mechanical ventilation.
Trial description: An open label, non-comparator, multi-centre study to assess the safety, efficacy and pharmacokinetics of remifentanil in Intensive Care Unit patients with varying degrees of renal dysfunction requiring analgesia and sedation in association with mechanical ventilation.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Breen D, Wilmer A, Bodenham A et al. Offset of pharmacodynamic effects and safety of remifentanil in intensive care unit patients with various degrees of renal impairment. Critical Care 2004 8: R21-30.
Pitsiu M, Wilmer A, Bodenham A et al. Pharmacokinetics of remifentanil and its major metabolite remifentanil acid in ICU patients with renal impairment. British Journal of Anaesthesia 2004 92:4;493-503.
Medical condition
Anaesthesia
Product
remifentanil
Collaborators
Not applicable
Study date(s)
February 2000 to September 2000
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2000-10-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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