|- candidate number||1190|
|- NTR Number||NTR117|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||14-aug-2005|
|- Secondary IDs||N/A |
|- Public Title||Costs and effects of strategies to prevent oversedation in Intensive Care patients.|
|- Scientific Title||Randomized trial comparing the effects of BIS monitoring and daily wake up with clinical assessment on ICU length of stay and costs in sedated ICU patients.|
|- hypothesis||Objective: |
To compare patient safety, inversely estimated as the duration of ICU stay, and costs between three groups of patients:
1. Those in whom sedatives will be administered continuously and in whom sedation level will be monitored clinically and with BIS (index group 1).
2. Patients in whom the administration of sedatives will be interrupted daily (index group 2).
3. Patients in whom sedative agents will be administered continuously and in whom sedation level will be assessed clinically (reference group).
Research question – Which of the three strategies mentioned above is associated with shortest duration of ICU stay and with lowest costs?
|- Healt Condition(s) or Problem(s) studied||Oversedation, Intensive Care (IC) patients|
|- Inclusion criteria||1. Consecutive ICU patients who are 18 years or older;|
2. Patients who are sedated for less than 24 hours;
3. Patients who are expected to need sedation for at least another day.
|- Exclusion criteria||1. Patients who have been transferred from another ICU where sedative agents have been administered for more than 24 hours;|
2. Patients with a decreased level of consciousness (defined as a Glasgow Coma Scale score of 12 or lower immediately before sedatives were administrated), will also be excluded;
3. Patients with an acute cerebral disease in whom the level of consciousness may decrease during admission.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2004|
|- planned closingdate||1-jan-2007|
|- Target number of participants||600|
|- Interventions||Patients will be randomised to one of the following three arms of the trial:|
1. Continuous infusion of sedative agents and clinical assessment of the level of sedation with BIS monitoring (index group 1);
2. Daily interruption of sedative infusions (index group 2);
3. Continuous infusion of sedative agents and clinical assessment of the level of sedation (reference group).
|- Primary outcome||Duration of ICU stay, which is used as an inverse indicator of patient safety.|
|- Secondary outcome||1. The duration of mechanical ventilation;|
2. The number and type of accidentally removed catheters;
3. The use and type of additional diagnostic tests to evaluate possible oversedation;
4. The number of re-admissions to the ICU;
5. The length of hospital stay;
6. The score on the questionnaire on stressful events (Rotondi);
7. Cumulative survival from admission to the ICU until three months;
8. Direct, medical costs of used health care resources and indirect, non-medical costs of lost productivity.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. M.B. Vroom|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. M.B. Vroom|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Background: |
Sedatives are frequently administered to Intensive Care Unit (ICU) patients to facilitate mechanical ventilation. As many of these patients have metabolic alterations, oversedation is very common.
Oversedation presents as difficulties in weaning from the mechanical ventilator, which increases the risk of several conditions as well as costs. Currently, the level of sedation is estimated clinically. However, this is impossible once a patient is not responsive due to deep sedation.
The recently developed bispectral index (BIS) monitor may increase accuracy of sedation assessment.
To increase patient safety in the administration of sedative agents in the ICU.
Multicentre, randomised controlled trial.
Study population - ICU patients from three university hospitals and one non-university hospital in the Netherlands.
Continuous infusion of sedative agents and assessment of the level of sedation with clinical monitoring and the BIS score, the weighted sum of different EEG parameters
(index group 1): daily interruption of sedative infusions
(index group 2): and continuous infusion of sedatives and clinical assessment of the level of sedation (reference group).
Duration of ICU stay, inversely indicating patient safety (primary).
Secondary outcomes include:
survival until three months after admission to the ICU, length of hospital stay, frequency of stressful experiences in the patients, and medical and non-medical costs.
A cost-minimisation analysis will be performed including direct, medical costs of used health care resources and indirect, non-medical costs of lost productivity.
Unit costing will be done in accordance with existing Dutch guidelines for health care research.
Patient outcome assessment will be restricted to recollections of stressful events during ICU stay.
|- Main changes (audit trail)|
|- RECORD||10-aug-2005 - 4-nov-2009|