The impact of high versus standard enteral protein provision on functional recovery following intensive care admission (PRECISE trial): study protocol for a randomized controlled, quadruple blinded, multicenter, parallel group trial in mechanically ventilated patients
Rob J. J. van GasselJulia L.M. BelsKatrien TartagliaBas C. T. van BusselSander M. J. van KuijkAdam M. DeaneZudin PuthuchearyPeter J.M. WeijsLilian VloetBert BeishuizenAshley De Bie DekkerVincent FraipontStoffel LamoteDidier LedouxClarissa I. E. ScheerenElisabeth De WaeleArthur R. H. van ZantenDieter MesottenMarcel C.G. van de Poll
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Abstract Background Critically 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. Methods The 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. Discussion The PRECISe trial will evaluate the effect of protein on functional recovery including both patient-centered and muscle-related outcomes. Trial registration ClinicalTrials.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.Keywords:
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Nutrition practices for preterm infants during the first few weeks of life can be divided into three phases: the parenteral nutrition (PN), enteral nutrition (EN), and transition (TN) phases; the TN phase includes both PN and EN. Our purpose was to analyze nutrition practices for very preterm infants during the TN phase and their association with the infants' growth during the first 28 days of life.Data from 268 very preterm infants <32 weeks old from six neonatal intensive care units were analyzed retrospectively. The TN phase was defined as enteral feedings of 30-120 ml/kg/d. Postnatal growth failure (PGF) was defined as a 28-day growth velocity <15 g/kg/d. Differences in protein and energy intake between the PGF and non-PGF groups during the TN phase were calculated, and risk factors for PGF were identified using multivariate regression analysis.The total protein (parenteral + enteral) intake during the TN was 3.16 (2.89, 3.47) g/kg/d, which gradually decreased as the enteral feeding volume increased in the TN phase. The total energy (parenteral + enteral) intake during the TN phase was 115.72 (106.98, 122.60) kcal/kg/d. The PGF group had a lower total protein intake (parenteral + enteral) than the non-PGF group had [3.09 (2.85, 3.38) g/kg/d vs. 3.27 (3.06, 3.57) g/kg/d, P = 0.007, respectively]. No significant difference was found in energy intake during the TN phase. The variables associated with PGF included a lower total protein (parenteral + enteral) intake, a smaller day of age at the end of the TN phase, and a higher birth weight z-score.Increasing the total protein intake (parenteral + enteral) during the TN could reduce the incidence of PGF.
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Objective To investigate the clinical efficacy of enteral nutrition support in patients with mechanical ventilation.Methods Eighty-four mechanically ventilated patients in intensive care unit(ICU) were divided into enteral nutrition(EN) group(n=42) and parenteral nutrition(PN) group(n=42).The PN group received energy by central venous pathways,while the EN group by nasogastric tube.Nutritional indicators,immune indicators and disease outcome indicators,complications in the two groups were observed before and after treatment.Results After treatment,nutrition indicators and immune parameters were significantly higher in the EN group than in the PN group.Mechanical ventilation duration and ICU admission duration were significantly less than in the PN group.Mortality and complications were significantly lower than in the PN group.Conclusion Enteral nutrition support can improve the mechanical ventilation in critically ill patients,nutritional status and immune function,and promote the rehabilitation of patients.
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• We sought to determine whether an excess in energy intake as total parenteral nutrition would result in liver biochemical and histological changes in the presence of a functional gastrointestinal tract. Three groups of rats were given amounts of total parenteral nutrition that provided either 25% (total parenteral nutrition-25), 100% (total parenteral nutrition-100), or 200% (total parenteral nutrition-200) of a rat's energy requirements. Rat chow and water were available ad libitum. Food intake decreased in proportion to the amount of total parenteral nutrition infused; it ceased with total parenteral nutrition-200. Liver glycogen and triglyceride concentrations were higher with high energy intake (total parenteral nutrition-100 and total parenteral nutrition-200), while total liver nitrogen concentrations remained unchanged. No cholestasis, inflammation, or fibrosis was seen histologically. Fatty vacuoles were increased with total parenteral nutrition (more so with total parenteral nutrition-200) but a prompt return to normal liver features was observed after cessation of total parenteral nutrition and the resumption of normal food intake. (Arch Surg. 1990;125:447-450)
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Objective To assess the combined application of staged enteral and parenteral nutrition support in patients with acute pancreatitis. Methods Sixty patients with acute pancreatitis who underwent conservative treatment were divided into total parenteral nutrition and staged parenteral and enteral nutrition. The changes of clinical indicators and clinical outcome were recorded. Results All of the 30 cases in the total parenteral nutrition+enteral nutrition group tolerated the enteral nutrition.One week after nutrition support from parenteral nutrition to enteral nutrition, total protein serum albumin and blood calcium significantly increased (P0.01);ALT and AST significantly decreased (P0.01).The blood glucose was significantly decreased (P0.05).The average hospital stay was shorter in the total parenteral nutrition+enteral nutrition group than in the total parenteral nutrition group(P0.05),and the average charge and total charge were cheaper in the total parenteral nutrition+enteral nutrition group than in the total parenteral nutrition group.Conclusion The results of glucose and nutritional indicators in total parenteral nutrition and enteral nutrition are better than in total parenteral nutrition group.
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Total Parenteral Nutrition (TPN), which uses intravenous administration of nutrients, minerals and vitamins, is essential in sustaining premature infants until they transition to enteral feeds. There is limited information on metabolomic differences between infants on TPN and enteral feeds. We performed untargeted global metabolomics on urine samples collected between 23-30 days of life from 314 infants born &lt;29 weeks gestational age from the TOLSURF and PROP cohorts. Principal component analysis across all metabolites showed a separation of infants solely on TPN as compared to infants who had transitioned to enteral feeds, indicating global metabolomic differences between infants based on feeding status. Among 913 metabolites that passed quality control filters, 609 varied in abundance between infants on TPN vs enteral feeds at p&lt;0.05. Of these, 88% were in the direction of higher abundance in the urine of infants on enteral feeds. In a subset of infants with longitudinal analysis, both concurrent and delayed changes in metabolite levels were observed with initiation of enteral feeds. Infants on enteral feeds had higher concentrations of essential amino acids, lipids, and vitamins, which are necessary for growth and development, suggesting a nutritional benefit of an enteral feeding regimen.
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Total Parenteral Nutrition (TPN), which uses intravenous administration of nutrients, minerals and vitamins, is essential for sustaining premature infants until they transition to enteral feeds, but there is limited information on metabolomic differences between infants on TPN and enteral feeds. We performed untargeted global metabolomics on urine samples collected between 23–30 days of life from 314 infants born <29 weeks gestational age from the TOLSURF and PROP cohorts. Principal component analysis across all metabolites showed a separation of infants solely on TPN compared to infants who had transitioned to enteral feeds, indicating global metabolomic differences between infants based on feeding status. Among 913 metabolites that passed quality control filters, 609 varied in abundance between infants on TPN vs. enteral feeds at p < 0.05. Of these, 88% were in the direction of higher abundance in the urine of infants on enteral feeds. In a subset of infants in a longitudinal analysis, both concurrent and delayed changes in metabolite levels were observed with the initiation of enteral feeds. These infants had higher concentrations of essential amino acids, lipids, and vitamins, which are necessary for growth and development, suggesting the nutritional benefit of an enteral feeding regimen.
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To review and discuss the evidence and arguments to combine enteral nutrition and parenteral nutrition in the ICU, in particular with reference to the Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients (EPaNIC) study.The EPaNIC study shows an advantage in terms of discharges alive from the ICU when parenteral nutrition is delayed to day 8 as compared with combining enteral nutrition and parenteral nutrition from day 3 of ICU stay.The difference between the guidelines from the European Society of Enteral and Parenteral Nutrition in Europe and American Society for Parenteral and Enteral Nutrition/Society of Critical Care Medicine in North America concerning the combination of enteral nutrition and parenteral nutrition during the initial week of ICU stay was reviewed. The EPaNIC study clearly demonstrates that early parenteral nutrition in the ICU is not in the best interests of most patients. Exactly at what time point the combination of enteral nutrition and parenteral nutrition should be considered is still an open question.
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To examine the aluminum content of several commercially available enteral nutrition formulas and parenteral solutions.Twelve enteral nutrition formulas and 10 parenteral solutions were commonly used in routine clinical care of patients and obtained from different medical companies in Turkey. The aluminum contents were determined by electrothermal atomic absorption spectrophotometry.We found that aluminum concentration in the enteral nutrition formulas and the parenteral solutions to range from 87.6 to 961.2 ng/mL and 58.4 to 1232.0 ng/mL, respectively.Careful clinical and biochemical monitoring are warranted to determine whether it will be necessary to eliminate aluminum contamination of enteral and parenteral preparations used in patients, particularly infants, with reduced kidney function who may be at risk for aluminum intoxication.
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This study aimed to characterize which are the early determinants of immediate failure of the use of noninvasive mechanical ventilation (NIMV) outside the ICU.This prospective study included patients who were admitted to the Military Hospital in Guayaquil, Ecuador. Each variable was analyzed independently by using a multiple logistic regression model toward establishing an association with the event.A total of 249 cases of NIMV over a 10 year period of its application outside the ICU was included in the study. Fifty-five (22.10%) patients were transferred to the ICU, A multivariate analysis showed that the determinants of immediate NIMV failure outside the ICU were the following: age (OR: 1.12; P = 0.03); SBP (OR: 1.04; P = 0.001); HR (OR: 1.66; P < 0.0001); pCO₂ (OR: 1.16; P = 0.007); pO2 (OR: 1.35; P = 0.003); levels of IPAP (OR: 1.35; P < 0.0001); and the number of quadrants affected, as shown in a chest X-ray (OR: 1.40; P < 0.0001).The number of affected quadrants in a chest X-ray, tachyarrhythmia and hypoxemia may be useful in the initial decision in the use of NIMV outside the ICU. High values of IPAP, the persistence of elevated pCO₂, arterial hypotension, and age could be useful as a second screening associated with immediate NIMV failure outside the ICU.
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