An interventional study of Multicomponent intervention program in Agitation,Psychomotor, sponsored by Radboud University Medical Center. Recruiting at 5 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
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Despite deleterious effects, physical restraints are still commonly used in (expected to become) agitated patients in Dutch ICUs (20-25%). This study aims to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints in (expected to become) agitated adult ICU patients.
Applying physical restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated. Nonetheless, PR are still used in approximately 20-25% of all patients during their intensive care unit (ICU) stay in the Netherlands. The aim of this study is to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints on short- and long-term outcomes and healthcare costs in (expected to become) agitated adult ICU patients.
231 studies on the registry are indexed under Psychomotor Agitation; 28 are open to participants now.
This study's planned enrollment of 480 is above the median of 100 across 188 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Multicomponent intervention program
Other: Multicomponent intervention program
Standard care
Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed
ICU-free days
Time frame: 28 days
Incidence rate of accidentally removed medical devices
Time frame: 14 days
Incidence rate of (self-extubation induced) reintubations
Time frame: 14 days
Days with delirium
Assessed using the Intensive Care Delirium Screening Checklist (ICDSC), Confusion Assessment Method for the ICU (CAM-ICU), or the Delirium Observation Screening scale for the ward (DOS)
Time frame: 14 days
Days with coma
Assessed using the Richmond Agitation and Sedation Scale (RASS)
Time frame: 14 days
Number of delirium- and coma-free days
Time frame: 14 days
Days with physical restraints
Time frame: 14 days
Days with dexmedetomidine (and total administered dose)
Time frame: 14 days
Dexmedetomidine related adverse events (e.g., hypotension, bradycardia) that required intervention
Time frame: 14 days
Days with propofol (and total administered dose)
Time frame: 14 days
Duration of mechanical ventilation in days
Time frame: up to 180 days
Hospital length of stay in days
Time frame: up to 180 days
Mortality
Time frame: at 28 days, 3 months and 12 months
Physical outcome
E.g., fatigue, frailty, new or worsened physical problems, assessed using validated questionnaires
Time frame: at ICU admission, 3, 12 and 24 months
Mental outcome
E.g., post traumatic stress disorder (PTSD), anxiety, depression, assessed using validated questionnaires
Time frame: at ICU admission 3, 12 and 24 months
Cognitive outcome
E.g., cognitive impairment, assessed using a validated questionnaire
Time frame: at 3, 12 and 24 months
Quality of life
Assessed using a validated QoL questionnaire
Time frame: at ICU admission, 3, 12 and 24 months
Cost-effectiveness
Measured by cost per Quality-Adjusted Life Year (QALY)
Time frame: 12 months
Incidence rate of falls out of bed
Time frame: 14 days
A secondary Bayesian analysis of the trial including heterogeneity of treatment effect
A secondary Bayesian analysis of the trial including heterogeneity of treatment effect
Time frame: To be conducted within one year after study completion
Plan to share: Yes — upon reasonable request
Ran from Jun 2023 to primary completion in Oct 2025, 28 months.
Of 36 non-industry interventional studies with no phase under Psychomotor Agitation, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 42. This study's 28 months is above that.
Counting every sponsor, half of 36 studies reached it within 17 months; a quarter within 6 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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