Delirium Clinical Trial
— DLAOfficial title:
Dynamic Light Application to Prevent ICU Acquired Delirium
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
Status | Completed |
Enrollment | 1000 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Jeroen Bosch Hospital | Den bosch |
Lead Sponsor | Collaborator |
---|---|
Jeroen Bosch Ziekenhuis |
Netherlands,
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* Note: There are 38 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | delirium outcome | 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) | duration of ICU stay(average duration 5 days) | No |
Secondary | ICU length-of-stay and ICU mortality | ICU length-of-stay and ICU mortality | duration of ICU stay, (average duration 5 days) | No |
Secondary | duration of mechanical ventilation | duration of ICU stay (average duration 5 days) | No | |
Secondary | Hospital length-of-stay and hospital mortality | duration of hospital stay (average duration 14 days) | No | |
Secondary | serum levels of inflammatory markers and markers of brain damage | 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. | duration of ICU stay (average duration 5 days) | No |
Secondary | urinary levels of markers of circadian rhythm | 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 | duration of ICU stay (average duration 5 days) | No |
Secondary | data of Health-related Quality of Life (HrQoL) questionnaires | 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 | during ICU stay and 3, 6 and 12 months after ICU discharge | No |
Secondary | Delirium-free days without coma in 28 days | 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 | 28 days | No |
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