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Dynamic Light Application to Prevent ICU Acquired Delirium (DLA)

This study is currently recruiting participants.
Verified April 2013 by Jeroen Bosch Ziekenhuis
Sponsor:
Information provided by (Responsible Party):
K.S. Simons, Jeroen Bosch Ziekenhuis
ClinicalTrials.gov Identifier:
NCT01274819
First received: January 11, 2011
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

Rationale: Delirium is a frequently encountered problem in ICU patients and leads to increased morbidity and mortality; Delirium in the ICU is associated with sleep deprivation which is among others caused by a disrupted circadian rhythm; Dynamic Light application aims at restoring a proper circadian rhythm by rhythmically alternating light intensity and has shown beneficial effects in sleep quality. Whether DLA improves sleep quality and reduces delirium incidence in ICU patients is not known

Goals/endpoints:

To evaluate the feasibility of dynamic light application in the ICU and to study the effects of dynamic light application on the incidence of delirium, duration of mechanical ventilation, the number of ICU and hospital days, and mortality in a mixed population of medical and surgical ICU patients. In a subgroup of patients with a high risk of developing delirium, markers of circadian rhythm, inflammation and brain damage and post ICU HRQoL will be assessed Study design: prospective randomized single centre trial Study population: adult ICU patients > 18 years old with an expected duration of stay of more than 24 hours Intervention: Patients will be randomized between Standard Care or Standard Care + DLA; When receiving standard care, normal lighting settings will be used in that patient room, which can be controlled by the medical personnel; In the rooms of patients randomized to the DLA group, DL is applied with a changing intensity during the day according to a fixed rhythm, which is regulated centrally. In addition when necessary, an intervention light can be used which can be operated in the patient room.

Study parameters/endpoints: incidence of delirium as measured by the CAM-ICU; duration of mechanical ventilation, ICU and total hospital mortality; ICU and hospital LOS; Serum levels of inflammatory markers and markers of brain damage, urinary levels of markers of circadian rhythm, data of HRQoL questionnaires and total light exposure in both groups


Condition Intervention
Delirium
Confusion
 Other: Dynamic Light

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dynamic Light Application to Prevent ICU Acquired Delirium

Resource links provided by NLM:

MedlinePlus related topics: Delirium
U.S. FDA Resources

Further study details as provided by Jeroen Bosch Ziekenhuis:

Primary Outcome Measures:
  • delirium outcome [ Time Frame: duration of ICU stay(average duration 5 days) ] [ Designated as safety issue: No ]
    This is a composite endpoint of incidence of delirium during ICU stay, 28-day delirium free days (28-DFD) and 28-day ventilator free days (28-VFD)


Secondary Outcome Measures:
  • ICU length-of-stay and ICU mortality [ Time Frame: duration of ICU stay, (average duration 5 days) ] [ Designated as safety issue: No ]
    ICU length-of-stay and ICU mortality

  • duration of mechanical ventilation [ Time Frame: duration of ICU stay (average duration 5 days) ] [ Designated as safety issue: No ]
  • Hospital length-of-stay and hospital mortality [ Time Frame: duration of hospital stay (average duration 14 days) ] [ Designated as safety issue: No ]
  • serum levels of inflammatory markers and markers of brain damage [ Time Frame: duration of ICU stay (average duration 5 days) ] [ Designated as safety issue: No ]
    when patients are considered to be at high risk of developing ICU acquired delirium ( using a validated scoring system) blood samples will be drawn on days 1, 3, 5, 7, 14, 21, and 28 after inclusion in the study and stored at -80 degrees until analysis.

  • urinary levels of markers of circadian rhythm [ Time Frame: duration of ICU stay (average duration 5 days) ] [ Designated as safety issue: No ]
    in a subgroup of long-stay ICU patients 3-hour urinary samples of cortisol and melatonin will taken during 24 hours to determine the circadian rhythm and the possible effect of DLA on this rhythm

  • data of Health-related Quality of Life (HrQoL) questionnaires [ Time Frame: during ICU stay and 3, 6 and 12 months after ICU discharge ] [ Designated as safety issue: No ]
    3 and 6 months after ICU discharge, a validated HrQoL will be sent to patients homes to assess their QoL after the ICU stay and to detect differences between the DLA and reference group

  • Delirium-free days without coma in 28 days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    To assess whether Dynamic Light not only influences incidence of delirium, but also duration of delirium, 28-day delirium free days without coma is used as a marker of duration of delirium. Patients who leave the ICU with a delirium (defined as a positive CAM-ICU score within 3 days of ICU discharge) will be followed on the wards using nurse charts and the delirium observation scale (DOS) to assess duration of delirium after ICU discharge


Estimated Enrollment: 1000
Study Start Date: July 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dynamic light
ICU patients exposed to dynamic light during ICU stay
 Other: Dynamic Light
Dynamic Light Application (DLA) is a light application which exposes the subject in the room to a varying light intensity and light temperature during the day thus mimicking a natural daylight exposure.
Other Name: Philips
No Intervention: Normal Light
control group is exposed to normal light during ICU stay

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ICU-patients >18 yrs old
  • expected duration of stay > 24 hrs

Exclusion Criteria:

  • life expectancy of <48 hrs on ICU admission
  • necessity of prolonged deep sedation
  • blindness
  • inability to speak or understand dutch
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274819

Contacts
Contact: KS Simons, drs +31 (0)735532447 k.simons@jbz.nl
Contact: C.P.C de Jager, drs +31 (0)735532447 p.dejager@jbz.nl

Locations
Netherlands
Jeroen Bosch Hospital Recruiting
Den bosch, Netherlands, 5211 nl
Contact: Jeroen Jansen     +31(0)735532857     J.Jansen3@jbz.nl    
Contact: Jeannette Schoep     +31(0)735538725     j.schoep@jbz.nl    
Principal Investigator: KS Simons, drs            
Sub-Investigator: C.P.C. de Jager, drs            
Sponsors and Collaborators
Jeroen Bosch Ziekenhuis
Investigators
Principal Investigator: KS Simons, drs Jeroen Bosch Hospital
  More Information

Publications:

Responsible Party: K.S. Simons, Drs, Jeroen Bosch Ziekenhuis
ClinicalTrials.gov Identifier: NCT01274819     History of Changes
Other Study ID Numbers: DLA 2011
Study First Received: January 11, 2011
Last Updated: April 16, 2013
Health Authority: The Netherlands; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Jeroen Bosch Ziekenhuis:
delirium
confusion

Additional relevant MeSH terms:
Confusion
Delirium
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013