Elsevier

Clinical Nutrition

Volume 35, Issue 1, February 2016, Pages 18-26
Clinical Nutrition

Randomized control trials
Readmission and mortality in malnourished, older, hospitalized adults treated with a specialized oral nutritional supplement: A randomized clinical trial

https://doi.org/10.1016/j.clnu.2015.12.010Get rights and content
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Summary

Background

Hospitalized, malnourished older adults have a high risk of readmission and mortality.

Objective

Evaluation of a high-protein oral nutritional supplement (HP-HMB) containing beta-hydroxy-beta-methylbutyrate on postdischarge outcomes of nonelective readmission and mortality in malnourished, hospitalized older adults.

Design

Multicenter, randomized, placebo-controlled, double-blind trial.

Setting

Inpatient and posthospital discharge.

Patients

Older (≥65 years), malnourished (Subjective Global Assessment [SGA] class B or C) adults hospitalized for congestive heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease.

Interventions

Standard-of-care plus HP-HMB (n = 328) or a placebo supplement (n = 324), 2 servings/day.

Measurements

Primary composite endpoint was 90-day postdischarge incidence of death or nonelective readmission. Other endpoints included 30- and 60-day postdischarge incidence of death or readmission, length of stay (LOS), SGA class, body weight, and activities of daily living (ADL).

Results

The primary composite endpoint was similar between HP-HMB (26.8%) and placebo (31.1%). No between-group differences were observed for 90-day readmission rate, but 90-day mortality was significantly lower with HP-HMB relative to placebo (4.8% vs. 9.7%; relative risk 0.49, 95% confidence interval [CI], 0.27 to 0.90; p = 0.018). The number-needed-to-treat to prevent 1 death was 20.3 (95% CI: 10.9, 121.4). Compared with placebo, HP-HMB resulted in improved odds of better nutritional status (SGA class, OR, 2.04, 95% CI: 1.28, 3.25, p = 0.009) at day 90, and an increase in body weight at day 30 (p = 0.035). LOS and ADL were similar between treatments.

Limitations

Limited generalizability; patients represent a selected hospitalized population.

Conclusions

Although no effects were observed for the primary composite endpoint, compared with placebo HP-HMB decreased mortality and improved indices of nutritional status during the 90-day observation period.

Clinical trial registration

www.ClinicalTrials.gov NCT01626742.

Keywords

High-protein beta-hydroxy-beta-methylbutyrate
Hospitalization
Lean body mass
Malnourished
NOURISH study
Oral nutritional supplement

Abbreviations

ADL
activities of daily living
AMI
acute myocardial infarction
CHF
congestive heart failure
CI
confidence interval
COPD
chronic pulmonary obstructive disease
HMB
beta-hydroxy-beta-methylbutyrate
HP-HMB
high-protein beta-hydroxy-beta-methylbutyrate
ITT
intention-to-treat
LBM
lean body mass
LOS
length of stay
LS
least squares
MMSE
Mini Mental State Examination
NNT
number needed to treat
NOURISH
Nutrition effect On Unplanned ReadmIssions and Survival in Hospitalized patients
ONS
oral nutritional supplements
PNA
pneumonia
QoL
quality of life
SD
standard deviation
SE
standard error
SGA
Subjective Global Assessment

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