Valk, J. van der (Joukje (2013) Feasibility study of a randomized controlled trial investigating the effect of clonidine-enhanced sedation on delirium in critically ill ventilated patients. thesis, Medicine.
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Abstract
Context: The incidence of delirium in the intensive care unit is high, especially in sedated and mechanically ventilated patients. Delirium in the ICU is associated with high morbidity and mortality. Recent studies with clonidine and dexmedetomidine suggest a niche for the use of alpha-2 agonists in the treatment and prevention of delirium in all ICU patients. In the critical care setting clonidine is widely used for sedation and to prevent or treat delirium, though large studies investigating this are lacking. Objective: To test the feasibility of a randomised controlled trial investigating if enhanced sedation with clonidine in ventilated critically ill ICU patients is safe and leads to a lower incidence and shorter duration of delirium (CATAPRES trial). This is a test run of the protocol. Design and population: An open-label pilot study in 10 sedated and mechanically ventilated ICU patients. Setting: Deventer Hospital, Deventer, the Netherlands. Method: Patients were treated with clonidine on indication of the clinician without randomisation. The CAM-ICU was used to assess delirium. During the trial the protocol, forms and database were evaluated several times. Changes to improve the study protocol have been made during this pilot study. Main Outcome Measures: Technical flaws and adjustments of the protocol, forms and database. Results and evaluation of the implementation of the CAM-ICU. Results: There was a switch in comparator from midazolam to the placebo natriumcloride. About one third of all study results was missing, because of delay between intubation and start of the study and because results from transferred patients were not obtained. Assessment of the CAM-ICU greatly improved by training of the nurses, improvement of the forms and recognition of the possibility the CAM-ICU cannot be assessed if patients are unable to obey any command. Many other technical flaws occurred for which adjustments were made to the protocol. Conclusions: This pilot study discovered and adjusted many technical flaws in the design, the feasibility was improved, this will increase the quality of the CATAPRES trial.
| Item Type: | Thesis (Thesis) |
|---|---|
| Supervisor name: | Oever, H.L.A. van den and Deventer Hospital |
| Faculty: | Medical Sciences |
| Date Deposited: | 25 Jun 2020 10:53 |
| Last Modified: | 25 Jun 2020 10:53 |
| URI: | https://umcg.studenttheses.ub.rug.nl/id/eprint/1382 |
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