Costs and effects of strategies to prevent oversedation in Intensive Care patients
| ISRCTN | ISRCTN43010133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43010133 |
| Secondary identifying numbers | NTR117 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 06/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof M.B. Vroom
Scientific
Scientific
Academic Medical Center
Intensive Care Volwassenen
C3-423
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Study information
| Study design | Multicentre, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| 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. |
| Study objectives | Objective: To compare patient safety, inversely estimated as the duration of Intensive Care Unit (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 Bispectral Index (BIS) (index group 1) 2. Patients in whom the administration of sedatives will be interrupted daily (index group 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? |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Oversedation in intensive care |
| Intervention | 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) |
| Intervention type | Other |
| Primary outcome measure | Duration of ICU stay, which is used as an inverse indicator of patient safety. |
| Secondary outcome measures | 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 over sedation 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 |
| Overall study start date | 01/12/2004 |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 600 |
| Key inclusion criteria | Consecutive ICU patients who are 18 years or older, who are sedated for less than 24 hours and who are expected to need sedation for at least another day. |
| Key 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) 3. Patients with an acute cerebral disease in whom the level of consciousness may decrease during admission |
| Date of first enrolment | 01/12/2004 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
University/education
University/education
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Research organisation
The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
