Prevention of ICU delirium and delerium related outcome with haloperidol: a study protocol for a multi center radomised controlled trial
Prevention of ICU delirium and delerium related outcome with haloperidol: a study protocol for a multi center radomised controlled trial
Background: delirium is a frequent disorder in intensive care unit (ICU) patients with serious consequences. Therefore, preventive treatment for delirium may be beneficial. Worldwide, haloperidol is the first choice for pharmacological treatment of delirious patients. In daily clinical practice, a lower dose is sometimes used as prophylaxis. Some studies have shown the beneficial effects of prophylactic haloperidol on delirium incidence as well as on mortality, but evidence for effectiveness in ICU patients is limited. The primary objective of our study is to determine the effect of haloperidol prophylaxis on 28-day survival. Secondary objectives include the incidence of delirium and delirium-related outcome and the side effects of haloperidol prophylaxis.
Methods: this will be a multicenter three-armed randomized, double-blind, placebo-controlled, prophylactic intervention study in critically ill patients. We will include consecutive non-neurological ICU patients, aged ?18 years with an expected ICU length of stay >1 day. To be able to demonstrate a 15% increase in 28-day survival time with a power of 80% and alpha of 0.05 in both intervention groups, a total of 2,145 patients will be randomized; 715 in each group. The anticipated mortality rate in the placebo group is 12%. The intervention groups will receive prophylactic treatment with intravenous haloperidol 1 mg/q8h or 2 mg/q8h, and patients in the control group will receive placebo (sodium chloride 0.9%), both for a maximum period of 28-days. In patients who develop delirium, study medication will be stopped and patients will subsequently receive open label treatment with a higher (therapeutic) dose of haloperidol. We will use descriptive summary statistics as well as Cox proportional hazard regression analyses, adjusted for covariates.
Discussion: this will be the first large-scale multicenter randomized controlled prevention study with haloperidol in ICU patients with a high risk of delirium, adequately powered to demonstrate an effect on 28-day survival
Van den Boogaard, B.M.
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Slooter, A.J.
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Bruggeman, R.J.M.
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Schoonhoven, Lisette
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Kuiper, M.A.
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van der Voort, P.J.H.
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Hoogendoorn, M.E.
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Beishuizen, A.
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Schouten, J.
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Spronk, P.E.
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Houterman, S.
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Van der Hoeven, J.G.
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Pickkers, P.
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Van den Boogaard, B.M.
aa15c610-6e6a-47be-bce9-731a8fa5ffb9
Slooter, A.J.
aebd7da7-b349-4267-8a72-cf116573d6d9
Bruggeman, R.J.M.
f3ec30f6-73a7-4d53-879a-fec5710c4806
Schoonhoven, Lisette
46a2705b-c657-409b-b9da-329d5b1b02de
Kuiper, M.A.
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van der Voort, P.J.H.
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Hoogendoorn, M.E.
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Beishuizen, A.
52941244-279b-40e3-9e69-88cf88725628
Schouten, J.
9915afd6-814d-421d-9e71-0a6625c0aa60
Spronk, P.E.
492c310b-fa77-4992-bf1b-eab87d9e42ca
Houterman, S.
cc2555a6-7fbf-47c1-b722-8d7b19527821
Van der Hoeven, J.G.
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Pickkers, P.
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Van den Boogaard, B.M., Slooter, A.J., Bruggeman, R.J.M., Schoonhoven, Lisette, Kuiper, M.A., van der Voort, P.J.H., Hoogendoorn, M.E., Beishuizen, A., Schouten, J., Spronk, P.E., Houterman, S., Van der Hoeven, J.G. and Pickkers, P.
(2013)
Prevention of ICU delirium and delerium related outcome with haloperidol: a study protocol for a multi center radomised controlled trial.
Trials, 14.
(doi:10.1186/1745-6215-14-400).
(PMID:24261644)
Abstract
Background: delirium is a frequent disorder in intensive care unit (ICU) patients with serious consequences. Therefore, preventive treatment for delirium may be beneficial. Worldwide, haloperidol is the first choice for pharmacological treatment of delirious patients. In daily clinical practice, a lower dose is sometimes used as prophylaxis. Some studies have shown the beneficial effects of prophylactic haloperidol on delirium incidence as well as on mortality, but evidence for effectiveness in ICU patients is limited. The primary objective of our study is to determine the effect of haloperidol prophylaxis on 28-day survival. Secondary objectives include the incidence of delirium and delirium-related outcome and the side effects of haloperidol prophylaxis.
Methods: this will be a multicenter three-armed randomized, double-blind, placebo-controlled, prophylactic intervention study in critically ill patients. We will include consecutive non-neurological ICU patients, aged ?18 years with an expected ICU length of stay >1 day. To be able to demonstrate a 15% increase in 28-day survival time with a power of 80% and alpha of 0.05 in both intervention groups, a total of 2,145 patients will be randomized; 715 in each group. The anticipated mortality rate in the placebo group is 12%. The intervention groups will receive prophylactic treatment with intravenous haloperidol 1 mg/q8h or 2 mg/q8h, and patients in the control group will receive placebo (sodium chloride 0.9%), both for a maximum period of 28-days. In patients who develop delirium, study medication will be stopped and patients will subsequently receive open label treatment with a higher (therapeutic) dose of haloperidol. We will use descriptive summary statistics as well as Cox proportional hazard regression analyses, adjusted for covariates.
Discussion: this will be the first large-scale multicenter randomized controlled prevention study with haloperidol in ICU patients with a high risk of delirium, adequately powered to demonstrate an effect on 28-day survival
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Boogaard et al Prevention of ICU delerium2014.pdf
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e-pub ahead of print date: November 2013
Organisations:
Physical & Rehabilitation Health
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Local EPrints ID: 362353
URI: http://eprints.soton.ac.uk/id/eprint/362353
ISSN: 1745-6215
PURE UUID: 7dafd37c-27ce-4d57-b5da-43e68f967ec4
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Date deposited: 20 Feb 2014 14:17
Last modified: 15 Mar 2024 03:41
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Contributors
Author:
B.M. Van den Boogaard
Author:
A.J. Slooter
Author:
R.J.M. Bruggeman
Author:
M.A. Kuiper
Author:
P.J.H. van der Voort
Author:
M.E. Hoogendoorn
Author:
A. Beishuizen
Author:
J. Schouten
Author:
P.E. Spronk
Author:
S. Houterman
Author:
J.G. Van der Hoeven
Author:
P. Pickkers
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