Condition category
Signs and Symptoms
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
06/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof M.B. Vroom

ORCID ID

Contact details

Academic Medical Center
Intensive Care Volwassenen
C3-423
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR117

Study information

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.

Acronym

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/12/2004

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant 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

Recruitment start date

01/12/2004

Recruitment end date

01/01/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

http://www.amc.uva.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes