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Daily interruption of sedation in critically ill children.


- candidate number6529
- NTR NumberNTR2030
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-sep-2009
- Secondary IDsMEC-2009-156 METC Erasmus MC Rotterdam
- Public TitleDaily interruption of sedation in critically ill children.
- Scientific TitleDaily interruption of sedation + protocolized sedation (DSI+PS) vs. protocolized sedation (PS) in critically ill children.
- ACRONYM
- hypothesisDaily interruption of sedation combined with protocolized sedation in critically ill children receiving mechanical ventilation will result in more ventilator-free days than protocolized sedation only.
- Healt Condition(s) or Problem(s) studiedOpioids, Paediatric patients, Sedation, Critically ill children, Midazolam, Pharmacokinetics, Pharmacodynamics
- Inclusion criteria1. Age 0-17 years;
2. At least 37 weeks of post conceptual age;
3. Anticipated duration of mechanical ventilation of > 48 hours;
4. Need for sedative/analgesic drugs;
5. Parental informed consent.
- Exclusion criteria1. Anticipated death whitin 48 hours;
2. Withdrawal of life support/DNR;
3. Patients in whom level of sedation cannot be scored with COMFORT behavior score due to neurological abnormalities;
4. Neurological, respiratory or cardiac instability that may not tolerate inadequate sedation;
5. Withdrawal of informed consent.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2009
- planned closingdate1-okt-2012
- Target number of participants200
- InterventionsPatients will be randomised in two groups:
1. Daily interruption of sedative infusions and protocolized sedation (intervention group);
2. Protocolized sedation only (control group).
- Primary outcomeThe number of ventilator-free days at 28 days, as defined by the number of days a patient breathes without mechanical assistance for at least 48 consecutive hours from day 1 to day 28 after randomization.
- Secondary outcome1. Safety (auto-extubation and reintubation, accidental displacement of catheters and feeding tubes, changes in blood pressure, heart rate, respiratory rate or alarms in those parameters that need medication on adjustments in ventilator settings);
2. Dosing requirements for sedative drugs;
3. Adequacy of sedation (based on scores outside of ranges);
4. Incidence of withdrawal symptoms;
5. Length of stay in the inetnsive care unit and in hospital (days);
6. 30-day mortality;
7. Costs at 28 days;
8. Incidence of posttraumatic stress disorder symptoms and quality of life at 3 months.
- TimepointsPatients are followed during their stay at the pediatric intenisve care unit and the hospital, with a maximum of 28 days. Three months after discharge quality of life and symptoms of posttraumatic stress disorder will be assessed using validated questionnaires.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M. Hoog, de
- CONTACT for SCIENTIFIC QUERIESDr. M. Hoog, de
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Sophia Children's Hospital
- PublicationsN/A
- Brief summaryIn adult intensive care (ICU) patients, daily interruption of sedation (DSI) is an effective method of improving sedation management and results in a decrease of the duration of mechanical ventilation, length of stay in the ICU and length of stay in the hospital. The aim of this multicentre, randomized controlled study is to determine the feasibility and efficacy of DSI in pediatric intensive care patients.
- Main changes (audit trail)
- RECORD28-sep-2009 - 4-nov-2009


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