NCT05783505

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jun 2023Oct 2026

First Submitted

Initial submission to the registry

January 8, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

2.3 years

First QC Date

January 8, 2023

Last Update Submit

June 12, 2025

Conditions

Agitation,Psychomotor

Keywords

ICUAgitationPhysical RestraintsNon-pharmacologic interventionsDexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • ICU-free days

    28 days

Secondary Outcomes (17)

  • Incidence rate of accidentally removed medical devices

    14 days

  • Incidence rate of (self-extubation induced) reintubations

    14 days

  • Days with delirium

    14 days

  • Days with coma

    14 days

  • Number of delirium- and coma-free days

    14 days

  • +12 more secondary outcomes

Other Outcomes (2)

  • Incidence rate of falls out of bed

    14 days

  • A secondary Bayesian analysis of the trial including heterogeneity of treatment effect

    To be conducted within one year after study completion

Study Arms (2)

Treatment group

EXPERIMENTAL

Multicomponent intervention program

Other: Multicomponent intervention program

Control group

NO INTERVENTION

Standard care

Interventions

Multicomponent intervention programOTHER

Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed

Treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult ICU patients (aged ≥18) with an expected ICU stay of \>24 hours
  • Patients who are (expected to become) agitated within the first 14 days of their ICU admission

You may not qualify if:

  • Contra indication for dexmedetomidine use (i.e., AV-block grade 2 or 3 unless a pacemaker is present, uncontrolled hypotension, acute cerebrovascular condition or known/suspected hypersensitivity);
  • Neurological patients with an (expected risk of) increased intracranial pressure;
  • An intoxication as a result of drug abuse (e.g., ethanol, γ-Hydroxybutyrate, opioids, benzodiazepines);
  • Support with Extracorporeal Membrane Oxygenation (ECMO);
  • Difficult airway (e.g., a Cormack and Lehane laryngoscopy grade 4 view or a tumor causing airway obstruction);
  • A high risk of physical aggression towards healthcare professionals;
  • No consent for long term follow up in the MONITOR-IC study;
  • Not able to read or understand the Dutch language and no relatives able to assist;
  • Enrolment in other sedation studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

RECRUITING

Bravis Ziekenhuis

Bergen op Zoom, Netherlands

RECRUITING

Amphia Ziekenhuis

Breda, Netherlands

RECRUITING

Elkerliek Ziekenhuis

Helmond, Netherlands

RECRUITING

VieCuri Medisch Centrum

Venlo, Netherlands

RECRUITING

Related Publications (1)

  • Kooken RWJ, Tilburgs B, Ter Heine R, Ramakers B, van den Boogaard M; PRAISE study group. A multicomponent intervention program to Prevent and Reduce AgItation and phySical rEstraint use in the ICU (PRAISE): study protocol for a multicenter, stepped-wedge, cluster randomized controlled trial. Trials. 2023 Dec 11;24(1):800. doi: 10.1186/s13063-023-07807-x.

    PMID: 38082351DERIVED

MeSH Terms

Conditions

Psychomotor Agitation

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Study Officials

  • Bram Tilburgs, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Mark van den Boogaard, PhD

    Radboud University Medical Center

    STUDY DIRECTOR

Central Study Contacts

Rens Kooken, MSc

CONTACT

+31 24 361 6735rens.kooken@radboudumc.nl

Bram Tilburgs, PhD

CONTACT

+31 24 361 4996bram.tilburgs@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicenter stepped wedge cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2023

First Posted

March 24, 2023

Study Start

June 1, 2023

Primary Completion

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

June 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

upon reasonable request

Locations

NL(5)