Randomised trial of daily interruption of sedative infusions in adult medical-surgical intensive care unit
| ISRCTN | ISRCTN69413086 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69413086 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/11/2006
- Registration date
- 23/04/2007
- Last edited
- 06/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Stella Anifantaki
Scientific
Scientific
Intensive Care Unit
Heraklion University Hospital
Voutes
Heraklion
71110
Greece
| stellaanifa@pathfinder.gr |
Study information
| Study design | Randomised trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 25/11/2004 |
| Completion date | 20/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Greece
Study participating centre
Intensive Care Unit
Heraklion
71110
Greece
71110
Greece
Sponsor information
Cretan Critical Care Society (Greece)
Research organisation
Research organisation
Intensive Care Unit
Heraklion University Hospital
Voutes
Heraklion
71110
Greece
| georgop@med.uoc.gr |
Funders
Funder type
Research organisation
Cretan Critical Care Society (Greece)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/05/2009 | 06/08/2021 | Yes | No |
Editorial Notes
06/08/2021: Publication reference and total final enrolment added.
