Randomised trial of daily interruption of sedative infusions in adult medical-surgical intensive care unit

ISRCTN	ISRCTN69413086
DOI	https://doi.org/10.1186/ISRCTN69413086
Protocol serial number	N/A
Sponsor	Cretan Critical Care Society (Greece)
Funder	Cretan Critical Care Society (Greece)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mrs Stella Anifantaki
Scientific

Intensive Care Unit
Heraklion University Hospital
Voutes
Heraklion
71110
Greece

Email	stellaanifa@pathfinder.gr

Primary study design	Observational
Study design	Randomised trial
Secondary study design	Randomised controlled trial
Scientific title	Randomised trial of daily interruption of sedative infusions in adult medical-surgical intensive care unit
Study objectives	To access the efficacy of daily interruption of sedative infusions versus interruption guided by the physician.
Ethics approval(s)	Approval received from the Ethics Board of University Hospital of Heraklion, Crete, on the 23rd November 2004 (ref: 10860).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Duration of stay in intensive care 2. Duration of mechanical ventilation 3. Length of stay in the hospital
Key secondary outcome measure(s)	1. Mortality in the intensive care 2. Mortality in the hospital 3. Doses of sedatives 4. Number of diagnostic tests of the brain
Completion date	20/03/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	100
Total final enrolment	97
Key inclusion criteria	Critically ill patients receiving sedation for 48 hours.
Key exclusion criteria	1. Pregnancy 2. Patients first-sedated in another hospital 3. Patients after CardioPulmonary Resuscitation (CPR)
Date of first enrolment	25/11/2004
Date of final enrolment	20/03/2006

Intensive Care Unit

Heraklion
71110
Greece

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/05/2009	06/08/2021	Yes	No

06/08/2021: Publication reference and total final enrolment added.