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. 2019 Sep 3;9(9):CD011749.
doi: 10.1002/14651858.CD011749.pub2.

Pharmacological interventions for the treatment of delirium in critically ill adults

Lisa Burry  1 , Brian Hutton, David R Williamson, Sangeeta Mehta, Neill Kj Adhikari, Wei Cheng, E Wesley Ely, Ingrid Egerod, Dean A Fergusson, Louise Rose
Affiliations

Pharmacological interventions for the treatment of delirium in critically ill adults

Lisa Burry et al. Cochrane Database Syst Rev. .

Abstract

Background: Although delirium is typically an acute reversible cognitive impairment, its presence is associated with devastating impact on both short-term and long-term outcomes for critically ill patients. Advances in our understanding of the negative impact of delirium on patient outcomes have prompted trials evaluating multiple pharmacological interventions. However, considerable uncertainty surrounds the relative benefits and safety of available pharmacological interventions for this population.

Objectives: Primary objective1. To assess the effects of pharmacological interventions for treatment of delirium on duration of delirium in critically ill adults with confirmed or documented high risk of deliriumSecondary objectivesTo assess the following:1. effects of pharmacological interventions on delirium-free and coma-free days; days with coma; delirium relapse; duration of mechanical ventilation; intensive care unit (ICU) and hospital length of stay; mortality; and long-term outcomes (e.g. cognitive; discharge disposition; health-related quality of life); and2. the safety of such treatments for critically ill adult patients.

Search methods: We searched the following databases from their inception date to 21 March 2019: Ovid MEDLINE®, Ovid MEDLINE® In-Process & Other Non-Indexed Citations, Embase Classic+Embase, and PsycINFO using the Ovid platform. We also searched the Cochrane Library on Wiley, the International Prospective Register of Systematic Reviews (PROSPERO) (http://www.crd.york.ac.uk/PROSPERO/), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Web of Science. We performed a grey literature search of relevant databases and websites using the resources listed in Grey Matters developed by the Canadian Agency for Drugs and Technologies in Health (CADTH). We also searched trial registries and abstracts from annual scientific critical care and delirium society meetings.

Selection criteria: We sought randomized controlled trials (RCTs), including quasi-RCTs, of any pharmacological (drug) for treatment of delirium in critically ill adults. The drug intervention was to be compared to another active drug treatment, placebo, or a non-pharmacological intervention (e.g. mobilization). We did not apply any restrictions in terms of drug class, dose, route of administration, or duration of delirium or drug exposure. We defined critically ill patients as those treated in an ICU of any specialty (e.g. burn, cardiac, medical, surgical, trauma) or high-dependency unit.

Data collection and analysis: Two review authors independently identified studies from the search results; four review authors (in pairs) performed data extraction and assessed risk of bias independently. We performed data synthesis through pairwise meta-analysis and network meta-analysis (NMA). Our hypothetical network structure was designed to be analysed at the drug class level and illustrated a network diagram of 'nodes' (i.e. drug classes) and 'edges' (i.e. comparisons between different drug classes from existing trials), thus describing a treatment network of all possible comparisons between drug classes. We assessed the quality of the body of evidence according to GRADE, as very low, low, moderate, or high.

Main results: We screened 7674 citations, from which 14 trials with 1844 participants met our inclusion criteria. Ten RCTs were placebo-controlled, and four reported comparisons of different drugs. Drugs examined in these trials were the following: antipsychotics (n = 10), alpha2 agonists (n = 3; all dexmedetomidine), statins (n = 2), opioids (n = 1; morphine), serotonin antagonists (n = 1; ondansetron), and cholinesterase (CHE) inhibitors (n = 1; rivastigmine). Only one of these trials consistently used non-pharmacological interventions that are known to improve patient outcomes in both intervention and control groups.Eleven studies (n = 1153 participants) contributed to analysis of the primary outcome. Results of the NMA showed that the intervention with the smallest ratio of means (RoM) (i.e. most preferred) compared with placebo was the alpha2 agonist dexmedetomidine (0.58; 95% credible interval (CrI) 0.26 to 1.27; surface under the cumulative ranking curve (SUCRA) 0.895; moderate-quality evidence). In order of descending SUCRA values (best to worst), the next best interventions were atypical antipsychotics (RoM 0.80, 95% CrI 0.50 to 1.11; SUCRA 0.738; moderate-quality evidence), opioids (RoM 0.88, 95% CrI 0.37 to 2.01; SUCRA 0.578; very-low quality evidence), and typical antipsychotics (RoM 0.96, 95% CrI 0.64 to1.36; SUCRA 0.468; high-quality evidence).The NMAs of multiple secondary outcomes revealed that only the alpha2 agonist dexmedetomidine was associated with a shorter duration of mechanical ventilation (RoM 0.55, 95% CrI 0.34 to 0.89; moderate-quality evidence), and the CHE inhibitor rivastigmine was associated with a longer ICU stay (RoM 2.19, 95% CrI 1.47 to 3.27; moderate-quality evidence). Adverse events often were not reported in these trials or, when reported, were rare; pair-wise analysis of QTc prolongation in seven studies did not show significant differences between antipsychotics, ondansetron, dexmedetomidine, and placebo.

Authors' conclusions: We identified trials of varying quality that examined six different drug classes for treatment of delirium in critically ill adults. We found evidence that the alpha2 agonist dexmedetomidine may shorten delirium duration, although this small effect (compared with placebo) was seen in pairwise analyses based on a single study and was not seen in the NMA results. Alpha2 agonists also ranked best for duration of mechanical ventilation and length of ICU stay, whereas the CHE inhibitor rivastigmine was associated with longer ICU stay. We found no evidence of a difference between placebo and any drug in terms of delirium-free and coma-free days, days with coma, physical restraint use, length of stay, long-term cognitive outcomes, or mortality. No studies reported delirium relapse, resolution of symptoms, or quality of life. The ten ongoing studies and the six studies awaiting classification that we identified, once published and assessed, may alter the conclusions of the review.

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Conflict of interest statement

None to declare: Lisa Burry, Neill KJ Adhikari, Wei Cheng, Ingrid Egerod, Dean A Fergusson, Brian Hutton, Sangeeta Mehta, Louise Rose, and David R Williamson.

To declare:

Dr Hutton has previously received honoraria from Cornerstone Research Group for providing methodological advice related to systematic reviews and meta‐analyses. This company does not market any products relevant to this review or therapeutic area.

Dr Ely is an author on four RCTs that met our inclusion criteria (i.e. Girard 2010a; Girard 2018; Page 2013; Page 2017). He was not involved in data extraction or risk of bias assessment for any of the RCTs. He is also supported by NIH funding, which is paid directly to Vanderbilt University. Dr Ely had received funds as honoraria for evidence‐based teaching activities from Orion, Hospira, and Abbott Laboratories education divisions (2015‐2017). At this time, these companies do not produce or market drugs with a specific indication for the treatment of delirium. They do market the sedative drug dexmedetomidine, which is included in this review. Dr Ely is not an author on the dexmedetomidine study included in this review. Dr Ely is currently studying as a co‐investigator in an NIH‐sponsored clinical trial on the off‐label use of delirium treatment.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Network diagrams of pairwise comparisons for the six outcomes with network meta‐analyses.
5
5
Forest plot of comparison: 1 Duration of delirium (log units), outcome: 1.1 Duration of delirium (log units).
6
6
Findings from network meta‐analysis: duration of delirium, delirium‐free and coma‐free days, and days with coma.
7
7
Consistency assumption check: posterior mean deviance contribution plots for RE consistency model vs unrelated means model; they did not suggest violation of the consistency assumption.
8
8
Forest plot of comparison: 2 Delirium‐free and coma‐free days (log units), outcome: 2.1 Delirium‐free and coma‐free days.
9
9
Forest plot of comparison: 3 Days with coma (log units), outcome: 3.1 Days with coma (log units).
10
10
Forest plot of comparison: 4 Duration of mechanical ventilation (log units), outcome: 4.1 Duration of mechanical ventilation (log units).
11
11
Findings from network meta‐analysis: duration of mechanical ventilation, length of ICU and hospital stay.
12
12
Forest plot of comparison: 5 Length of ICU stay (log units), outcome: 5.1 Length of ICU stay (log units).
13
13
Forest plot of comparison: 6 Length of hospital stay (log units), outcome: 6.1 Length of hospital stay (log units).
14
14
Forest plot of comparison: 7 Mortality, outcome: 7.1 Mortality.
15
15
Forest plot of comparison: 8 Akathisia, outcome: 8.1 Akathisia.
16
16
Forest plot of comparison: 9 Arrhythmias, outcome: 9.1 Arrhythmias.
17
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Forest plot of comparison: 10 QTc prolongation, outcome: 10.1 QTc prolongation.
18
18
Forest plot of comparison: 11 Extrapyramidal symptoms, outcome: 11.1 Extrapyramidal symptoms.
1.1
1.1. Analysis
Comparison 1 Duration of delirium (log ratio of means scale), Outcome 1 Duration of delirium (log units).
2.1
2.1. Analysis
Comparison 2 Delirium‐free and coma‐free days (log ratio of means scale), Outcome 1 Delirium‐free and coma‐free days.
3.1
3.1. Analysis
Comparison 3 Days with coma (log ratio of means scale), Outcome 1 Days with coma (log units).
4.1
4.1. Analysis
Comparison 4 Duration of mechanical ventilation (log ratio of means scale), Outcome 1 Duration of mechanical ventilation (log units).
5.1
5.1. Analysis
Comparison 5 Length of ICU stay (log ratio of means scale), Outcome 1 Length of ICU stay (log units).
6.1
6.1. Analysis
Comparison 6 Length of hospital stay (log ratio of means scale), Outcome 1 Length of hospital stay (log units).
7.1
7.1. Analysis
Comparison 7 Mortality, Outcome 1 Mortality.
8.1
8.1. Analysis
Comparison 8 Akathisia, Outcome 1 Akathisia.
9.1
9.1. Analysis
Comparison 9 Arrhythmias, Outcome 1 Arrhythmias.
10.1
10.1. Analysis
Comparison 10 QTc prolongation, Outcome 1 QTc prolongation.
11.1
11.1. Analysis
Comparison 11 Extrapyramidal symptoms, Outcome 1 Extrapyramidal symptoms.
See this image and copyright information in PMC

Update of

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References to other published versions of this review

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