OBJECTIVES:
To assess the efficacy of ramelteon in preventing delirium, an acute neuropsychiatric condition associated with increased morbidity and mortality, in the perioperative, ICU setting.

DESIGN:
Parallel-arm, randomized, double-blinded, placebo-controlled trial.

SETTING:
Academic medical center in La Jolla, California.

PATIENTS:
Patients greater than or equal to 18 years undergoing elective pulmonary thromboendarterectomy.

INTERVENTIONS:
Ramelteon 8 mg or matching placebo starting the night prior to surgery and for a maximum of six nights while in the ICU.

MEASUREMENTS AND MAIN RESULTS:
Incident delirium was measured twice daily using the Confusion Assessment Method-ICU. The safety outcome was coma-free days assessed by the Richmond Agitation-Sedation Scale. One-hundred twenty participants were enrolled and analysis completed in 117. Delirium occurred in 22 of 58 patients allocated to placebo versus 19 of 59 allocated to ramelteon (relative risk, 0.8; 95% CI, 0.5-1.4; p = 0.516). Delirium duration, as assessed by the number of delirium-free days was also similar in both groups (placebo median 2 d [interquartile range, 2-3 d] vs ramelteon 3 d [2-5 d]; p = 0.181). Coma-free days was also similar between groups (placebo median 2 d [interquartile range, 1-3 d] vs ramelteon 3 d [2-4 d]; p = 0.210). We found no difference in ICU length of stay (median 4 d [interquartile range, 3-5 d] vs 4 d [3-6 d]; p = 0.349), or in-hospital mortality (four vs three deaths; relative risk ratio, 0.7; 95% CI, 0.2-3.2; p = 0.717), all placebo versus ramelteon, respectively.

CONCLUSIONS:
Ramelteon 8 mg did not prevent postoperative delirium in patients admitted for elective cardiac surgery

PMID: 31567351 DOI: 10.1097/CCM.0000000000004004

OBJECTIVE:
ICU survivors suffer from long-lasting physical, mental, and cognitive health impairments, also called “postintensive care syndrome”. However, an overview of the effectiveness of interventions to prevent or mitigate these impairments is lacking. The aim of this study is to assess the effectiveness of nonpharmacologic interventions.

DATA SOURCES:
PubMed, CINAHL, PsycINFO, Embase, and Cochrane Library were systematically searched from inception until July 19, 2018.

STUDY SELECTION:
(Non)randomized clinical trials, controlled before-after studies, and interrupted time series were included. Outcomes of interest included patients’ physical, mental and cognitive outcomes, quality of life, and outcomes such as social functioning and functional status, measured after hospital discharge

DATA EXTRACTION:
Two independent reviewers selected studies, extracted data, and assessed the risk of bias. Pooled mean differences and standardized mean differences were calculated using random-effect meta-analyses.

DATA SYNTHESIS:
After screening 17,008 articles, 36 studies, including 10 pilot studies, were included (n = 5,165 ICU patients). Interventions were subdivided into six categories: 1) exercise and physical rehabilitation programs; 2) follow-up services; 3) psychosocial programs; 4) diaries; 5) information and education; and 6) other interventions. Many outcomes favored the interventions, but significant differences were only found for diaries in reducing depression (two studies, n = 88; standardized mean difference, 0.68; 95% CI, 0.14-1.21) and anxiety (two studies, n = 88; standardized mean difference, 0.44; 95% CI, 0.01-0.87) and exercise programs in improving the Short Form Health Survey-36 Mental Component Score (seven studies, n = 664; mean difference, 2.62; 95% CI, 0.92-4.32).

CONCLUSIONS:
There is thin evidence that diaries and exercise programs have a positive effective on mental outcomes. Despite outcomes favoring the intervention group, other commonly used nonpharmacologic interventions in daily ICU practice are not supported by conclusive evidence from this meta-analysis. To improve recovery programs for ICU survivors, more evidence is needed from robust intervention studies using standardized outcomes.

PMID: 31464769          DOI:  10.1097/CCM.0000000000003974