Condition category
Signs and Symptoms
Date applied
17/11/2006
Date assigned
23/04/2007
Last edited
21/09/2007
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

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

Publication citations

Additional files

Editorial Notes