Delirium Clinical Trial
— MICEOfficial title:
Melatonin Use in the Intensive Care Elderly Population
The investigators are studying the use of Melatonin in non-ventilated patients over the age of 65. Primary endpoint will be assesments of delirium, with secondary endpoints to include length of stay, use of anti-psychotic medications, and mortality
Status | Recruiting |
Enrollment | 600 |
Est. completion date | January 2018 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Non-ventilated Patients over the age of 65 Exclusion Criteria: - Patients with head trauma or Neurosurgical intervention - Patients <65 years of age - Patients with an expected life expectancy <48 hours - Blind patients - Patients with a seizure history - Patients with uncontrolled hypertension - Patients with a supratheraputic (>3.0) INR - Patients on strong CYP1A2 inhibitors: ciprofloxacin, fluvoxamine, methoxsalen, ofloxacin, primaquine - Patients who do not speak English or Spanish |
Country | Name | City | State |
---|---|---|---|
United States | Parkview Medical Center | Pueblo | Colorado |
Lead Sponsor | Collaborator |
---|---|
MICE Trial Group |
United States,
Arendt J. In what circumstances is melatonin a useful sleep therapy? Consensus statement, WFSRS focus group, Dresden, November 1999. J Sleep Res. 2000 Dec;9(4):397-8. Review. — View Citation
Artemiou P, Bily B, Bilecova-Rabajdova M, Sabol F, Torok P, Kolarcik P, Kolesar A. Melatonin treatment in the prevention of postoperative delirium in cardiac surgery patients. Kardiochir Torakochirurgia Pol. 2015 Jun;12(2):126-33. doi: 10.5114/kitp.2015.52853. Epub 2015 Jun 30. — View Citation
Bellapart J, Boots R. Potential use of melatonin in sleep and delirium in the critically ill. Br J Anaesth. 2012 Apr;108(4):572-80. doi: 10.1093/bja/aes035. Review. — View Citation
Bourne RS, Mills GH, Minelli C. Melatonin therapy to improve nocturnal sleep in critically ill patients: encouraging results from a small randomised controlled trial. Crit Care. 2008;12(2):R52. doi: 10.1186/cc6871. Epub 2008 Apr 18. — View Citation
Bourne RS, Mills GH. Melatonin: possible implications for the postoperative and critically ill patient. Intensive Care Med. 2006 Mar;32(3):371-9. Epub 2006 Feb 14. Review. — View Citation
Chakraborti D, Tampi DJ, Tampi RR. Melatonin and melatonin agonist for delirium in the elderly patients. Am J Alzheimers Dis Other Demen. 2015 Mar;30(2):119-29. doi: 10.1177/1533317514539379. Epub 2014 Jun 18. Review. — View Citation
Chen S, Shi L, Liang F, Xu L, Desislava D, Wu Q, Zhang J. Exogenous Melatonin for Delirium Prevention: a Meta-analysis of Randomized Controlled Trials. Mol Neurobiol. 2016 Aug;53(6):4046-4053. doi: 10.1007/s12035-015-9350-8. Epub 2015 Jul 21. — View Citation
Hatta K, Kishi Y, Wada K, Takeuchi T, Odawara T, Usui C, Nakamura H; DELIRIA-J Group. Preventive effects of ramelteon on delirium: a randomized placebo-controlled trial. JAMA Psychiatry. 2014 Apr;71(4):397-403. doi: 10.1001/jamapsychiatry.2013.3320. — View Citation
Huang HW, Zheng BL, Jiang L, Lin ZT, Zhang GB, Shen L, Xi XM. Effect of oral melatonin and wearing earplugs and eye masks on nocturnal sleep in healthy subjects in a simulated intensive care unit environment: which might be a more promising strategy for ICU sleep deprivation? Crit Care. 2015 Mar 19;19:124. doi: 10.1186/s13054-015-0842-8. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delirium | Length of Hospital Stay, Average of 1 week | ||
Secondary | Use of Antipsychotic Medications | Length of Hospital Stay, Average of 1 week | ||
Secondary | Average RASS Score | Length of Hospital Stay, Average of 1 week | ||
Secondary | ICU days | Length of Hospital Stay, Average of 1 week | ||
Secondary | Hospital Days | Length of Hospital Stay, Average of 1 week | ||
Secondary | 30 day mortality | 30 days post D/C | ||
Secondary | 90 day mortality | 90 days post D/C |
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