Your browser doesn't support javascript.
loading
Efficacy of haloperidol to decrease the burden of delirium in adult critically ill patients: the EuRIDICE randomized clinical trial.
Smit, Lisa; Slooter, Arjen J C; Devlin, John W; Trogrlic, Zoran; Hunfeld, Nicole G M; Osse, Robert Jan; Ponssen, Huibert H; Brouwers, Arjen J B W; Schoonderbeek, Jeannette F; Simons, Koen S; van den Boogaard, Mark; Lens, Judith A; Boer, Dirk P; Gommers, Diederik A M P J; Rietdijk, Wim J R; van der Jagt, Mathieu.
Afiliação
  • Smit L; Department of Intensive Care Adults, Erasmus MC-University Medical Centre, Room Ne-415, PO BOX 2040, 3000 CA, Rotterdam, The Netherlands.
  • Slooter AJC; Departments of Psychiatry, Intensive Care Medicine and UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
  • Devlin JW; Department of Neurology, UZ Brussel and Vrije Universiteit Brussel, Brussels, Belgium.
  • Trogrlic Z; School of Pharmacy, Northeastern University, Boston, USA.
  • Hunfeld NGM; Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, USA.
  • Osse RJ; Department of Intensive Care Adults, Erasmus MC-University Medical Centre, Room Ne-415, PO BOX 2040, 3000 CA, Rotterdam, The Netherlands.
  • Ponssen HH; Department of Intensive Care Adults, Erasmus MC-University Medical Centre, Room Ne-415, PO BOX 2040, 3000 CA, Rotterdam, The Netherlands.
  • Brouwers AJBW; Department of Hospital Pharmacy, Erasmus MC-University Medical Centre, Rotterdam, The Netherlands.
  • Schoonderbeek JF; Department of Psychiatry, Erasmus MC-University Medical Centre, Rotterdam, The Netherlands.
  • Simons KS; Department of Intensive Care, Albert Schweitzer Hospital, Dordrecht, The Netherlands.
  • van den Boogaard M; Department of Intensive Care Adults, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.
  • Lens JA; Department of Intensive Care, Ikazia Hospital, Rotterdam, The Netherlands.
  • Boer DP; Department of Intensive Care Medicine, Jeroen Bosch Hospital, 's Hertogenbosch, The Netherlands.
  • Gommers DAMPJ; Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
  • Rietdijk WJR; Department of Intensive Care, IJsselland Hospital, Capelle aan den IJssel, The Netherlands.
  • van der Jagt M; Department of Intensive Care, Maasstad Hospital, Rotterdam, The Netherlands.
Crit Care ; 27(1): 413, 2023 10 30.
Article em En | MEDLINE | ID: mdl-37904241
BACKGROUND: The role of haloperidol as treatment for ICU delirium and related symptoms remains controversial despite two recent large controlled trials evaluating its efficacy and safety. We sought to determine whether haloperidol when compared to placebo in critically ill adults with delirium reduces days with delirium and coma and improves delirium-related sequelae. METHODS: This multi-center double-blind, placebo-controlled randomized trial at eight mixed medical-surgical Dutch ICUs included critically ill adults with delirium (Intensive Care Delirium Screening Checklist ≥ 4 or a positive Confusion Assessment Method for the ICU) admitted between February 2018 and January 2020. Patients were randomized to intravenous haloperidol 2.5 mg or placebo every 8 h, titrated up to 5 mg every 8 h if delirium persisted until ICU discharge or up to 14 days. The primary outcome was ICU delirium- and coma-free days (DCFDs) within 14 days after randomization. Predefined secondary outcomes included the protocolized use of sedatives for agitation and related behaviors, patient-initiated extubation and invasive device removal, adverse drug associated events, mechanical ventilation, ICU length of stay, 28-day mortality, and long-term outcomes up to 1-year after randomization. RESULTS: The trial was terminated prematurely for primary endpoint futility on DSMB advice after enrolment of 132 (65 haloperidol; 67 placebo) patients [mean age 64 (15) years, APACHE IV score 73.1 (33.9), male 68%]. Haloperidol did not increase DCFDs (adjusted RR 0.98 [95% CI 0.73-1.31], p = 0.87). Patients treated with haloperidol (vs. placebo) were less likely to receive benzodiazepines (adjusted OR 0.41 [95% CI 0.18-0.89], p = 0.02). Effect measures of other secondary outcomes related to agitation (use of open label haloperidol [OR 0.43 (95% CI 0.12-1.56)] and other antipsychotics [OR 0.63 (95% CI 0.29-1.32)], self-extubation or invasive device removal [OR 0.70 (95% CI 0.22-2.18)]) appeared consistently more favorable with haloperidol, but the confidence interval also included harm. Adverse drug events were not different. Long-term secondary outcomes (e.g., ICU recall and quality of life) warrant further study. CONCLUSIONS: Haloperidol does not reduce delirium in critically ill delirious adults. However, it may reduce rescue medication requirements and agitation-related events in delirious ICU patients warranting further evaluation. TRIAL REGISTRATION: ClinicalTrials.gov (#NCT03628391), October 9, 2017.
Assuntos
Palavras-chave

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Antipsicóticos / Delírio Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Crit Care Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Holanda

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Antipsicóticos / Delírio Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Crit Care Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Holanda