Rivastigmine for Intensive Care Unit (ICU) Delirium

Phase 4 Terminated 104 enrolled UMC Utrecht Netherlands Brain Foundation · collab Novartis · collab ZonMw: The Netherlands Organisation for Health Research and Development · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Delirium in Intensive Care (IC) patients is a frequent disorder. The aim of this study is to investigate whether treatment of delirium in the ICU with rivastigmine added to haloperidol shortens the duration of delirium in comparison to placebo added to the treatment with haloperidol.

Timeline

Start: 2008-11
Primary completion: 2010-04
Completion: 2010-05

Outcome

Missed primary endpoint

Stopped: “The study is prematurely terminated due to a safety issue”

paper Median duration of delirium was longer in the rivastigmine group (5·0 days, IQR 2·7-14·2) than in the placebo group (3·0 days, IQR 1·0-9·3; p=0·06). PMID 21056464 ↗

paper Rivastigmine did not decrease duration of delirium and might have increased mortality PMID 21056464 ↗

Publications

van Eijk MM, Roes KC, Honing ML, Kuiper MA, Karakus A, van der Jagt M, Spronk PE, van Gool WA, van der Mast RC, Kesecioglu J, Slooter AJ. Effect of rivastigmine as an adjunct to usual care with haloperidol on duration of delirium and mortality in critically ill patients: a multicentre, double-blind, placebo-controlled randomised trial. Lancet. 2010 Nov 27;376(9755):1829-37. doi: 10.1016/S0140-6736(10)61855-7. Epub 2010 Nov 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rivastigmine	Small molecule	6 mg	—