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Dynamic Light Application to Prevent ICU Acquired Delirium (DLA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01274819
First Posted: January 12, 2011
Last Update Posted: October 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
K.S. Simons, Jeroen Bosch Ziekenhuis
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dynamic Light Application to Prevent ICU Acquired Delirium

Resource links provided by NLM:


Further study details as provided by K.S. Simons, Jeroen Bosch Ziekenhuis:

Primary Outcome Measures:
  • delirium outcome [ Time Frame: duration of ICU stay(average duration 5 days) ]
    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) ]
    ICU length-of-stay and ICU mortality

  • duration of mechanical ventilation [ Time Frame: duration of ICU stay (average duration 5 days) ]
  • Hospital length-of-stay and hospital mortality [ Time Frame: duration of hospital stay (average duration 14 days) ]
  • serum levels of inflammatory markers and markers of brain damage [ Time Frame: duration of ICU stay (average duration 5 days) ]
    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) ]
    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 ]
    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 ]
    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


Enrollment: 1000
Study Start Date: July 2011
Study Completion Date: September 2013
Primary Completion Date: September 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274819


Locations
Netherlands
Jeroen Bosch Hospital
Den bosch, Netherlands, 5211 nl
Sponsors and Collaborators
Jeroen Bosch Ziekenhuis
Investigators
Principal Investigator: KS Simons, drs Jeroen Bosch Hospital
  More Information

Publications:
Peterson JF, Pun BT, Dittus RS, Thomason JW, Jackson JC, Shintani AK, Ely EW. Delirium and its motoric subtypes: a study of 614 critically ill patients. J Am Geriatr Soc. 2006 Mar;54(3):479-84.
Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. Epub 2001 Nov 8.
Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62.
Thomason JW, Shintani A, Peterson JF, Pun BT, Jackson JC, Ely EW. Intensive care unit delirium is an independent predictor of longer hospital stay: a prospective analysis of 261 non-ventilated patients. Crit Care. 2005 Aug;9(4):R375-81. Epub 2005 Jun 1.
Ouimet S, Kavanagh BP, Gottfried SB, Skrobik Y. Incidence, risk factors and consequences of ICU delirium. Intensive Care Med. 2007 Jan;33(1):66-73. Epub 2006 Nov 11.
Pisani MA, Kong SY, Kasl SV, Murphy TE, Araujo KL, Van Ness PH. Days of delirium are associated with 1-year mortality in an older intensive care unit population. Am J Respir Crit Care Med. 2009 Dec 1;180(11):1092-7. doi: 10.1164/rccm.200904-0537OC. Epub 2009 Sep 10.
Balas MC, Happ MB, Yang W, Chelluri L, Richmond T. Outcomes Associated With Delirium in Older Patients in Surgical ICUs. Chest. 2009 Jan;135(1):18-25. doi: 10.1378/chest.08-1456. Epub 2008 Nov 18.
Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62.
Leslie DL, Marcantonio ER, Zhang Y, Leo-Summers L, Inouye SK. One-year health care costs associated with delirium in the elderly population. Arch Intern Med. 2008 Jan 14;168(1):27-32. doi: 10.1001/archinternmed.2007.4.
Devlin JW, Fong JJ, Howard EP, Skrobik Y, McCoy N, Yasuda C, Marshall J. Assessment of delirium in the intensive care unit: nursing practices and perceptions. Am J Crit Care. 2008 Nov;17(6):555-65; quiz 566.
Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76.
Vidán MT, Sánchez E, Alonso M, Montero B, Ortiz J, Serra JA. An intervention integrated into daily clinical practice reduces the incidence of delirium during hospitalization in elderly patients. J Am Geriatr Soc. 2009 Nov;57(11):2029-36. doi: 10.1111/j.1532-5415.2009.02485.x. Epub 2009 Sep 15.
Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.
Riker RR, Shehabi Y, Bokesch PM, Ceraso D, Wisemandle W, Koura F, Whitten P, Margolis BD, Byrne DW, Ely EW, Rocha MG; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009 Feb 4;301(5):489-99. doi: 10.1001/jama.2009.56. Epub 2009 Feb 2.
Pandharipande PP, Pun BT, Herr DL, Maze M, Girard TD, Miller RR, Shintani AK, Thompson JL, Jackson JC, Deppen SA, Stiles RA, Dittus RS, Bernard GR, Ely EW. Effect of sedation with dexmedetomidine vs lorazepam on acute brain dysfunction in mechanically ventilated patients: the MENDS randomized controlled trial. JAMA. 2007 Dec 12;298(22):2644-53.
Maldonado JR, Wysong A, van der Starre PJ, Block T, Miller C, Reitz BA. Dexmedetomidine and the reduction of postoperative delirium after cardiac surgery. Psychosomatics. 2009 May-Jun;50(3):206-17. doi: 10.1176/appi.psy.50.3.206.
Devlin JW, Roberts RJ, Fong JJ, Skrobik Y, Riker RR, Hill NS, Robbins T, Garpestad E. Efficacy and safety of quetiapine in critically ill patients with delirium: a prospective, multicenter, randomized, double-blind, placebo-controlled pilot study. Crit Care Med. 2010 Feb;38(2):419-27. doi: 10.1097/CCM.0b013e3181b9e302.
Han CS, Kim YK. A double-blind trial of risperidone and haloperidol for the treatment of delirium. Psychosomatics. 2004 Jul-Aug;45(4):297-301.
Kalisvaart KJ, de Jonghe JF, Bogaards MJ, Vreeswijk R, Egberts TC, Burger BJ, Eikelenboom P, van Gool WA. Haloperidol prophylaxis for elderly hip-surgery patients at risk for delirium: a randomized placebo-controlled study. J Am Geriatr Soc. 2005 Oct;53(10):1658-66.
Cooper AB, Thornley KS, Young GB, Slutsky AS, Stewart TE, Hanly PJ. Sleep in critically ill patients requiring mechanical ventilation. Chest. 2000 Mar;117(3):809-18. Erratum in: Chest 2001 Mar;119(3):993.
Freedman NS, Gazendam J, Levan L, Pack AI, Schwab RJ. Abnormal sleep/wake cycles and the effect of environmental noise on sleep disruption in the intensive care unit. Am J Respir Crit Care Med. 2001 Feb;163(2):451-7.
Weinhouse GL, Schwab RJ, Watson PL, Patil N, Vaccaro B, Pandharipande P, Ely EW. Bench-to-bedside review: delirium in ICU patients - importance of sleep deprivation. Crit Care. 2009;13(6):234. doi: 10.1186/cc8131. Epub 2009 Dec 7. Review.
Shirani A, St Louis EK. Illuminating rationale and uses for light therapy. J Clin Sleep Med. 2009 Apr 15;5(2):155-63. Review.
Van Someren EJ, Kessler A, Mirmiran M, Swaab DF. Indirect bright light improves circadian rest-activity rhythm disturbances in demented patients. Biol Psychiatry. 1997 May 1;41(9):955-63.
Satlin A, Volicer L, Ross V, Herz L, Campbell S. Bright light treatment of behavioral and sleep disturbances in patients with Alzheimer's disease. Am J Psychiatry. 1992 Aug;149(8):1028-32.
Wilson LM. Intensive care delirium. The effect of outside deprivation in a windowless unit. Arch Intern Med. 1972 Aug;130(2):225-6.
Keep P, James J, Inman M. Windows in the intensive therapy unit. Anaesthesia. 1980 Mar;35(3):257-62.
Taguchi T, Yano M, Kido Y. Influence of bright light therapy on postoperative patients: a pilot study. Intensive Crit Care Nurs. 2007 Oct;23(5):289-97. Epub 2007 Aug 9.
Scheer FA, Buijs RM. Light affects morning salivary cortisol in humans. J Clin Endocrinol Metab. 1999 Sep;84(9):3395-8.
Anderson JL, Glod CA, Dai J, Cao Y, Lockley SW. Lux vs. wavelength in light treatment of Seasonal Affective Disorder. Acta Psychiatr Scand. 2009 Sep;120(3):203-12. doi: 10.1111/j.1600-0447.2009.01345.x. Epub 2009 Feb 3.
Riemersma-van der Lek RF, Swaab DF, Twisk J, Hol EM, Hoogendijk WJ, Van Someren EJ. Effect of bright light and melatonin on cognitive and noncognitive function in elderly residents of group care facilities: a randomized controlled trial. JAMA. 2008 Jun 11;299(22):2642-55. doi: 10.1001/jama.299.22.2642.
Cajochen C, Zeitzer JM, Czeisler CA, Dijk DJ. Dose-response relationship for light intensity and ocular and electroencephalographic correlates of human alertness. Behav Brain Res. 2000 Oct;115(1):75-83.
Zeitzer JM, Dijk DJ, Kronauer R, Brown E, Czeisler C. Sensitivity of the human circadian pacemaker to nocturnal light: melatonin phase resetting and suppression. J Physiol. 2000 Aug 1;526 Pt 3:695-702.
Viola AU, James LM, Schlangen LJ, Dijk DJ. Blue-enriched white light in the workplace improves self-reported alertness, performance and sleep quality. Scand J Work Environ Health. 2008 Aug;34(4):297-306. Epub 2008 Sep 22.
Dijk DJ, Cajochen C. Melatonin and the circadian regulation of sleep initiation, consolidation, structure, and the sleep EEG. J Biol Rhythms. 1997 Dec;12(6):627-35. Review.
Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7.
Oostenbrink JB, Koopmanschap MA, Rutten FF. Standardisation of costs: the Dutch Manual for Costing in economic evaluations. Pharmacoeconomics. 2002;20(7):443-54.
Aurell J, Elmqvist D. Sleep in the surgical intensive care unit: continuous polygraphic recording of sleep in nine patients receiving postoperative care. Br Med J (Clin Res Ed). 1985 Apr 6;290(6474):1029-32.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: K.S. Simons, Drs, Jeroen Bosch Ziekenhuis
ClinicalTrials.gov Identifier: NCT01274819     History of Changes
Other Study ID Numbers: DLA 2011
First Submitted: January 11, 2011
First Posted: January 12, 2011
Last Update Posted: October 16, 2013
Last Verified: October 2013

Keywords provided by K.S. Simons, Jeroen Bosch Ziekenhuis:
delirium
confusion

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders


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