BackgroundCritically ill patients are subject to severe skeletal muscle wasting during intensive care unit (ICU) stay, resulting in impaired short- and long-term functional outcomes and health-related quality of life. Increased protein provision may improve functional outcomes in ICU patients by attenuating skeletal muscle breakdown. Supporting evidence is limited however and results in great variety in recommended protein targets.MethodsThe PRECISe trial is an investigator-initiated, bi-national, multi-center, quadruple-blinded randomized controlled trial with a parallel group design. In 935 patients, we will compare provision of isocaloric enteral nutrition with either a standard or high protein content, providing 1.3 or 2.0 g of protein/kg/day, respectively, when fed on target. All unplanned ICU admissions with initiation of invasive mechanical ventilation within 24 h of admission and an expected stay on ventilator support of at least 3 days are eligible. The study is designed to assess the effect of the intervention on functional recovery at 1, 3, and 6 months following ICU admission, including health-related quality of life, measures of muscle strength, physical function, and mental health. The primary endpoint of the trial is health-related quality of life as measured by the Euro-QoL-5D-5-level questionnaire Health Utility Score. Overall between-group differences will be assessed over the three time points using linear mixed-effects models.DiscussionThe PRECISe trial will evaluate the effect of protein on functional recovery including both patient-centered and muscle-related outcomes.Trial registrationClinicalTrials.gov Identifier: NCT04633421. Registered on November 18, 2020. First patient in (FPI) on November 19, 2020. Expected last patient last visit (LPLV) in October 2023.
MULTIFILE
BackgroundICU patients lose muscle mass rapidly and maintenance of muscle mass may contribute to improved survival rates and quality of life. Protein provision may be beneficial for preservation of muscle mass and other clinical outcomes, including survival. Current protein recommendations are expert-based and range from 1.2 to 2.0 g/kg. Thus, we performed a systematic review and meta-analysis on protein provision and all clinically relevant outcomes recorded in the available literature.MethodsWe conducted a systematic review and meta-analyses, including studies of all designs except case control and case studies, with patients aged ≥18 years with an ICU stay of ≥2 days and a mean protein provision group of ≥1.2 g/kg as compared to <1.2 g/kg with a difference of ≥0.2 g/kg between protein provision groups. All clinically relevant outcomes were studied. Meta-analyses were performed for all clinically relevant outcomes that were recorded in ≥3 included studies.ResultsA total of 29 studies published between 2012 and 2022 were included. Outcomes reported in the included studies were ICU, hospital, 28-day, 30-day, 42-day, 60-day, 90-day and 6-month mortality, ICU and hospital length of stay, duration of mechanical ventilation, vomiting, diarrhea, gastric residual volume, pneumonia, overall infections, nitrogen balance, changes in muscle mass, destination at hospital discharge, physical performance and psychological status. Meta-analyses showed differences between groups in favour of high protein provision for 60-day mortality, nitrogen balance and changes in muscle mass.ConclusionHigh protein provision of more than 1.2 g/kg in critically ill patients seemed to improve nitrogen balance and changes in muscle mass on the short-term and likely 60-day mortality. Data on long-term effects on quality of life are urgently needed.
MULTIFILE
Background: Lipoedema is a chronic disorder of adipose tissue typically involving an abnormal build-up of fat cells in the legs, thighs and buttocks. Occurring almost exclusively in women, it often co-exists with obesity. Due to an absence of clear objective diagnostic criteria, lipoedema is frequently misdiagnosed as obesity, lymphoedema or a combination of both. The purpose of this observational study was to compare muscle strength and exercise capacity in patients with lipoedema and obesity, and to use the findings to help distinguish between lipoedema and obesity. Design: This cross-sectional, comparative pilot study performed in the Dutch Expertise Centre of Lymphovascular Medicine, Drachten, a secondary-care facility, included 44 women aged 18 years or older with lipoedema and obesity. Twenty-two women with lipoedema (diagnosed according the criteria of Wold et al, 1951) and 22 women with body mass index ≥30kg/m2 (obesity) were include in the study. No interventions were undertaken as part of the study. Results: Muscle strength of the quadriceps was measured with the MicroFET™, and functional exercise capacity was measured with the 6-minute walk test. The group with lipoedema had, for both legs, significantly lower muscle strength (left: 259.9 Newtons [N]; right: 269.7 N; p < 0.001) than the group with obesity. The group with lipoedema had a non-significant, but clinically relevant lower exercise-endurance capacity (494.1±116.0 metres) than the group with obesity (523.9±62.9 metres; p=0.296). Conclusions: Patients with lipoedema exhibit muscle weakness in the quadriceps. This finding provides a potential new criterion for differentiating lipoedema from obesity. We recommend adding measuring of muscle strength and physical endurance to create an extra diagnostic parameter when assessing for lipoedema.
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