scholarly journals Efficacy of halopeRIdol to decrease the burden of Delirium In adult Critically ill patiEnts (EuRIDICE): study protocol for a prospective randomised multi-centre double-blind placebo-controlled clinical trial in the Netherlands

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036735
Author(s):  
Lisa Smit ◽  
Zoran Trogrlić ◽  
John W Devlin ◽  
Robert-Jan Osse ◽  
Huibert H Ponssen ◽  
...  
Keyword(s):  
Intensive Care ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Controlled Trial ◽  
Neurological Injury ◽  
Study Endpoint ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Icu Discharge

IntroductionDelirium in critically ill adults is associated with prolonged hospital stay, increased mortality and greater cognitive and functional decline. Current practice guideline recommendations advocate the use of non-pharmacological strategies to reduce delirium. The routine use of scheduled haloperidol to treat delirium is not recommended given a lack of evidence regarding its ability to resolve delirium nor improve relevant short-term and longer-term outcomes. This study aims to evaluate the efficacy and safety of haloperidol for the treatment of delirium in adult critically ill patients to reduce days spent with coma or delirium.Methods and analysisEuRIDICE is a prospective, multi-centre, randomised, double-blind, placebo-controlled trial. Study population consists of adult intensive care unit (ICU) patients without acute neurological injury who have delirium based on a positive Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method for the ICU (CAM-ICU) assessment. Intervention is intravenous haloperidol 2.5 mg (or matching placebo) every 8 hours, titrated daily based on ICDSC or CAM-ICU positivity to a maximum of 5 mg every 8 hours, until delirium resolution or ICU discharge. Main study endpoint is delirium and coma-free days (DCFD) up to 14 days after randomisation. Secondary endpoints include (1) 28-day and 1-year mortality, (2) cognitive and functional performance at 3 and 12 months, (3) patient and family delirium and ICU experience, (4) psychological sequelae during and after ICU stay, (4) safety concerns associated with haloperidol use and (5) cost-effectiveness. Differences in DCFDs between haloperidol and placebo group will be analysed using Poisson regression analysis. Study recruitment started in February 2018 and continues.Ethics and disseminationThe study has been approved by the Medical Ethics Committee of the Erasmus University Medical Centre Rotterdam (MEC2017-511) and by the Institutional Review Boards of the participating sites. Its results will be disseminated via peer-reviewed publication and conference presentations.Trial registrationNCT03628391

scholarly journals Effects of probiotic therapy in critically ill patients: a randomized, double-blind, placebo-controlled trial

2007 ◽  
Vol 85 (3) ◽  
pp. 816-823 ◽  
Author(s):  
Cathy Alberda ◽  
Leah Gramlich ◽  
Jon Meddings ◽  
Catherine Field ◽  
Linda McCargar ◽  
...  
Keyword(s):  
Critically Ill ◽  
Critically Ill Patients ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Efficacy of Low-Dose Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

2019 ◽  
Vol 9 (1) ◽  
pp. 69
Author(s):  
Youlim Kim ◽  
Hyung-Sook Kim ◽  
Jong Sun Park ◽  
Young-Jae Cho ◽  
Ho Il Yoon ◽  
...  
Keyword(s):  
Placebo Group ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Low Dose ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Icu Discharge ◽  
Tertiary Teaching ◽  
Delirium Prevention

Purpose: To evaluate the efficacy of short-term low-dose quetiapine for delirium prevention in critically ill patients. Methods: In this prospective, a single-center, randomized, double-blind, placebo-controlled trial, adult patients who were admitted from July 2015 to July 2017 to a medical intensive care unit (ICU) of a tertiary teaching hospital affiliated to Seoul National University were included. Quetiapine (12.5 mg or 25 mg oral at night; N = 16) or placebo (N = 21) was administered according to randomization until ICU discharge or the 10th ICU day. The primary endpoint was the incidence of delirium within the first 10 ICU days. Secondary endpoints included the rate of positive Confusion Assessment Method for the ICU (CAM-ICU) (the number of positive CAM-ICU counts/the number of total CAM-ICU counts), delirium duration, successful extubation, and overall mortality. Result: The incidence of delirium during the 10 days after ICU admission was 46.7% (7/15) in the quetiapine group and 55.0% (11/20) in the placebo group (p = 0.442). In the quetiapine group, the rate of positive CAM-ICU was significantly lower than in the placebo group (14.4% vs. 37.4%, p = 0.048), delirium duration during the study period was significantly shorter (0.28 day vs. 1.83 days, p = 0.018), and more patients in the quetiapine than in the placebo group were weaned from mechanical ventilation successfully (84.6% vs. 47.1%, p = 0.040). Conclusions: Our study suggests that prophylactic use of low-dose quetiapine could be helpful for preventing delirium in critically ill patients. A further large-scale prospective study is needed.

Laxation of critically ill patients with lactulose or polyethylene glycol: A two-center randomized, double-blind, placebo-controlled trial *

2007 ◽  
Vol 35 (12) ◽  
pp. 2726-2731 ◽  
Author(s):  
Johan I. van der Spoel ◽  
Heleen M. Oudemans-van Straaten ◽  
Michael A. Kuiper ◽  
Eric N. van Roon ◽  
Durk F. Zandstra ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

Laxation of critically ill patients with lactulose or polyethylene glycol: A two-center randomized, double-blind, placebo-controlled trial*

2007 ◽  
Vol 35 (12) ◽  
pp. 2726-2731 ◽  
Author(s):  
Johan I. van der Spoel ◽  
Heleen M. Oudemans-van Straaten ◽  
Michael A. Kuiper ◽  
Eric N. van Roon ◽  
Durk F. Zandstra ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo
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