METHODS: This is a prospective observational study conducted among critically ill patients aged ≥18 years, intubated and mechanically ventilated within 48 h of ICU admission and stayed in the ICU for at least 72 h. Information on baseline characteristics and nutritional risk status (the modified Nutrition Risk in Critically ill [NUTRIC] score) was collected on day 1. Nutritional intake was recorded daily until death, discharge, or until the twelfth evaluable days. Mortality status was assessed on day 60 based on the patient's hospital record. Patients were divided into 3 groups a) received <2/3 of prescribed energy and protein (both <2/3), b) received ≥2/3 of prescribed energy and protein (both ≥2/3) and c) either energy or protein received were ≥2/3 of prescribed (either ≥2/3). The relationship between the three groups with 60-day mortality was examined by using logistic regression with adjustment for potential confounders. Sensitivity analysis was performed to examine the influence of ICU length of stay (≥7 days) and nutritional risk status.
RESULTS: Data were collected from 154 mechanically ventilated patients (age, 51.3 ± 15.7 years; body mass index, 26.5 ± 6.7 kg/m2; 54% male). The mean modified NUTRIC score was 5.7 ± 1.9, with 56% of the patients at high nutritional risk. The patients received 64.5 ± 21.6% of the amount of energy and 56.4 ± 20.6% of the amount of protein prescribed. Provision of energy and protein at ≥2/3 compared with <2/3 of the prescribed amounts was associated with a trend towards increased 60-day mortality (Adjusted odds ratio [Adj OR] 2.23; 95% confidence interval [CI], 0.92-5.38; p = 0.074). No difference in mortality status was found between energy and protein provision at either ≥2/3 compared with <2/3 of the prescribed amounts (Adj OR 1.61, 95% CI, 0.58-4.45; p = 0.357). Nutritional risk status, not ICU length of stay, influenced the relationship between nutritional adequacy and 60-day mortality.
CONCLUSIONS: Energy and protein adequacy of ≥2/3 of the prescribed amounts were associated with a trend towards increased 60-day mortality among mechanically ventilated critically ill patients. However, neither energy nor protein adequacy alone at ≥ or <2/3 adequacy affect 60-day mortality. Increased mortality was associated with provision of energy and protein at ≥2/3 of the prescribed amounts, which only affected patients with low nutritional risk.
DESIGN: A randomized, double-blind, parallel-group, controlled clinical trial.
SETTING: Diabetes clinic of a teaching hospital in Kuala Lumpur, Malaysia.
PARTICIPANTS: A total of 136 participants with type 2 diabetes, aged 30-70 years, were recruited and randomly assigned to receive either probiotics (n = 68) or placebo (n = 68) for 12 weeks.
OUTCOMES: Primary outcomes were glycemic control-related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The Lactobacillus and Bifidobacterium quantities were measured before and after intervention as an indicator of successful passage of the supplement through gastrointestinal tract.
STATISTICAL ANALYSIS: Intention-to-treat (ITT) analysis was performed on all participants, while per-protocol (PP) analysis was performed on those participants who had successfully completed the trial with good compliance rate.
RESULTS: With respect to primary outcomes, glycated hemoglobin decreased by 0.14 % in the probiotics and increased by 0.02 % in the placebo group in PP analysis (p