Contact information
Type
Scientific
Primary contact
Mrs Stella Anifantaki
ORCID ID
Contact details
Intensive Care Unit
Heraklion University Hospital
Voutes
Heraklion
71110
Greece
stellaanifa@pathfinder.gr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To access the efficacy of daily interruption of sedative infusions versus interruption guided by the physician.
Ethics approval
Approval received from the Ethics Board of University Hospital of Heraklion, Crete, on the 23rd November 2004 (ref: 10860).
Study design
Randomised trial
Primary study design
Observational
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Sedation in critically ill patients
Intervention
Daily interruption of sedative infusions. If during this process the patient needs sedation again then the sedation restarts at half the previous dose and adjusted to reach the desired level of sedation.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Duration of stay in intensive care
2. Duration of mechanical ventilation
3. Length of stay in the hospital
Secondary outcome measures
1. Mortality in the intensive care
2. Mortality in the hospital
3. Doses of sedatives
4. Number of diagnostic tests of the brain
Overall trial start date
25/11/2004
Overall trial end date
20/03/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Critically ill patients receiving sedation for 48 hours.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
1. Pregnancy
2. Patients first-sedated in another hospital
3. Patients after CardioPulmonary Resuscitation (CPR)
Recruitment start date
25/11/2004
Recruitment end date
20/03/2006
Locations
Countries of recruitment
Greece
Trial participating centre
Intensive Care Unit
Heraklion
71110
Greece
Sponsor information
Organisation
Cretan Critical Care Society (Greece)
Sponsor details
Intensive Care Unit
Heraklion University Hospital
Voutes
Heraklion
71110
Greece
georgop@med.uoc.gr
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Cretan Critical Care Society (Greece)
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