Baclofen to prevent agitation in alcohol-addicted patients in the ICU: Study protocol for a randomised controlled trial

Trials

Volumn 17, Issue 1, 2016, Pages

  Vourc'h, Mickael ^a,b   Feuillet, Fanny ^b,c   Mahe, Pierre Joachim ^a,b   Sebille, Véronique ^b,c   Asehnoune, Karim ^a,b   Lasocki, Sigismond ^d   Gergaud, Soizic ^d   Gaillard, Thomas ^d   Lascarrou, Jean Baptiste ^e   Vinatier, Isabelle ^e   Martin Lefevre, Laurent ^e   Yehia, Aihem ^e   Colin, Gwenhael ^e   Lebert, Christine ^e   Fiancette, Maud ^e   Henry Lagarrigue, Matthieu ^e   Lacherad, Jean Claude ^e   Jaber, Samir ^f   Jong, Audrey De ^f   Chanques, Gerald ^f   Roquilly, Antoine ^b   Cinotti, Raphaël ^b   Dit Latte, Dominique Demeure ^b   Reignier, Jean ^b   Garret, Charlotte ^b   Bretonniere, Céric ^b   Brule, Noëlle ^b   Nicolet, Laurent ^b   Zambon, Olivier ^b   Mimoz, Olivier ^g   Moriconi, Mikael ^h   Gacoin, Arnaud ⁱ   Tadie, Jean Marc ⁱ   Tulzo, Yves Le ⁱ   Lescot, Thomas ^j   Morin, Paul ^k   Jonas, Maud ^k   Thibaut, Freddy ^k   Ferrandiere, Martine ^l   more..

^a HÔTEL DIEU   (France)

^b NANTES UNIVERSITY HOSPITAL   (France)

^c UNIVERSITÉ DE NANTES   (France)

^d ANGERS UNIVERSITY HOSPITAL   (France)

^e Hospital Centre   (France)

^f MONTPELLIER UNIVERSITY HOSPITAL   (France)

^g POITIERS UNIVERSITY HOSPITAL   (France)

^h Intensive Care Unit   (France)

ⁱ RENNES UNIVERSITY HOSPITAL   (France)

^j Department of Pathology   (France)

^k Intensive Care Unit Hospital   (France)

^l UNIVERSITY HOSPITAL OF TOURS   (France)

more..

Author keywords

Alcohol withdrawal syndrome; Alcoholism; Baclofen; Delirium tremens; Intensive care; Restlessness

Indexed keywords

ANALGESIC AGENT; BACLOFEN; CREATININE; PLACEBO; SEDATIVE AGENT;

ADULT; AGED; AGGRESSION; ALCOHOL CONSUMPTION; ALCOHOLISM; ARTERY CATHETER; ARTICLE; ARTIFICIAL VENTILATION; CLINICAL PROTOCOL; CONTROLLED STUDY; CREATININE CLEARANCE; DEVICE REMOVAL; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; EXTUBATION; FRANCE; HUMAN; INTENSIVE CARE UNIT; INTRAVENOUS CATHETER; LENGTH OF STAY; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; OUTCOME ASSESSMENT; PATIENT SELECTION; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RESTLESSNESS; SEDATION; SURGICAL DRAINAGE; TRACHEOTOMY; TREATMENT DURATION; URINARY CATHETER; ADOLESCENT; FEMALE; MALE; MIDDLE AGED; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ALCOHOLISM; BACLOFEN; CLINICAL PROTOCOLS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INTENSIVE CARE UNITS; LENGTH OF STAY; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; PSYCHOMOTOR AGITATION; YOUNG ADULT;

EID: 84982311298     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-016-1539-2     Document Type: Article

References (28)

1. Alonso J, Ferrer M, Romera B. The European Study of the Epidemiology of Mental Disorders (ESEMeD/MHEDEA 2000) project: rationale and methods. 2002;11(2):55-67. doi: 10.1002/mpr.123.
2. Guerin S, Laplanche A, Dunant A. Alcohol-attributable mortality in France. 2013;23(4):588-93. doi: 10.1093/eurpub/ckt015.
3. Vourc'h G, Hatton F, Tiret L. Epidemiologic study of anesthesia complications in France. Bull Acad Natl Med. 1983;167(8):939-45.
4. Canarelli T, Cadet A, Palle C. Indicateurs de la morbidité et de la mortalité liées à l'alcool en France. Bull Epidemiol Hebdo. 2006;n°34-35:252-5.
5. Sanders RD, Pandharipande PP, Davidson AJ, Ma D, Maze M. Anticipating and managing postoperative delirium and cognitive decline in adults. BMJ. 2011;343:d4331.
6. Pandharipande P, Shintani A, Peterson J. Lorazepam is an independent risk factor for transitioning to delirium in intensive care unit patients. Anesthesiology. 2006;104(1):21-6.
7. Pisani MA, Murphy TE, Araujo KLB, Slattum P, Van Ness PH, Inouye SK. Benzodiazepine and opioid use and the duration of intensive care unit delirium in an older population. Crit Care Med. 2009;37(1):177-83. doi: 10.1097/CCM.0b013e318192fcf9.
8. Lavie P. Sleep disturbances in the wake of traumatic events. N Engl J Med. 2001;345(25):1825-32. doi: 10.1056/NEJMra012893.
9. Liang C, Chen J, Gu W. Chronic alcoholism increases the induction dose of propofol. Acta Anaesthesiol Scand. 2011;55(9):1113-7. doi: 10.1111/j.1399-6576.2011.02497.x.
10. Wolfson B, Freed B. Influence of alcohol on anesthetic requirements and acute toxicity. Anesthesia Analg. 1980;59(11):826-30.
11. Spies CD, Nordmann A, Brummer G, et al. Intensive care unit stay is prolonged in chronic alcoholic men following tumor resection of the upper digestive tract. Acta Anaesthesiol Scand. 1996;40(6):649-56.
12. Levkoff SE, Evans DA, Liptzin B, et al. Delirium. The occurrence and persistence of symptoms among elderly hospitalized patients. Arch Intern Med. 1992;152(2):334-40.
13. Francis J, Martin D, Kapoor WN. A prospective study of delirium in hospitalized elderly. JAMA. 1990;263(8):1097-101.
14. Ely EW, Shintani A, Truman B, et al. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
15. Griffin RE, Gross GA, Teitelbaum HS. Delirium tremens: a review. J Am Osteopath Assoc. 1993;93(9):924-929-32-935.
16. Kril JJ, Halliday GM. Brain shrinkage in alcoholics: a decade on and what have we learned? Prog Neurobiol. 1999;58(4):381-7.
17. Neiman J. Alcohol as a risk factor for brain damage: neurologic aspects. Alcohol Clin Exp Res. 1998;22(7 Suppl):346S-51.
18. Gacouin A, Tadie JM, Sauvadet E. At-risk drinking is independently associated with ICU and one-year mortality in critically ill nontrauma patients*. Crit Care Med. 2014;42(4):860-7. doi: 10.1097/CCM.0000000000000041.
19. Clark BJ, Williams A, Feemster LMC, et al. Alcohol screening scores and 90-day outcomes in patients with acute lung injury. Crit Care Med. 2013;41(6):1518-25. doi: 10.1097/CCM.0b013e318287f1bb.
20. Tønnesen H, Petersen KR, Højgaard L, et al. Postoperative morbidity among symptom-free alcohol misusers. Lancet. 1992;340(8815):334-7.
21. Addolorato G, Leggio L, Abenavoli L, et al. Baclofen in the treatment of alcohol withdrawal syndrome: a comparative study vs diazepam. Am J Med. 2006;119(3):276.e13-e18. doi: 10.1016/j.amjmed.2005.08.042.
22. Lyon JE, Khan RA, Gessert CE, Larson PM, Renier CM. Treating alcohol withdrawal with oral baclofen: a randomized, double-blind, placebo-controlled trial. J Hosp Med. 2011;6(8):469-74. doi: 10.1002/jhm.928.
23. Addolorato G, Leggio L, Ferrulli A, Cardone S. Effectiveness and safety of baclofen for maintenance of alcohol abstinence in alcohol-dependent patients with liver cirrhosis: randomised, double-blind controlled study. The Lancet. 2007;370(9603):1915-1922. doi: 10.1016/S0140-6736(07)61814-5.
24. Addolorato G, Leggio L, Ferrulli A, Cardone S, Bedogni G, Caputo F, et al. Dose--response effect of baclofen in reducing daily alcohol intake in alcohol dependence: secondary analysis of a randomized, double-blind, placebo-controlled trial. Alcohol and Alcoholism. 2011;46(3):312-317. doi: 10.1093/alcalc/agr017.
25. Rigal L, Alexandre-Dubroeucq C, de Beaurepaire R. Abstinence and 'low-risk' consumption 1 year after the initiation of high-dose baclofen: a retrospective study among 'high-risk' drinkers. Alcohol Alcohol. 2012;47(4):439-42. doi: 10.1093/alcalc/ags028.
26. Riker RR, Fraser GL. The new practice guidelines for pain, agitation, and delirium. Am J Crit Care. 2013;22(2):153-7. doi: 10.4037/ajcc2013480.
27. Friede T, Kieser M. Sample size recalculation for binary data in internal pilot study designs. Pharm Stat. 2004;3(4):269-79. doi: 10.1002/pst.140.
28. Friede T, Kieser M. Sample size recalculation in internal pilot study designs: a review. Biom J. 2006;48(4):537-55.