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Early metabolic support for critically ill trauma patients: A prospective randomized controlled trial.
Stolarski, AE, Young, L, Weinberg, J, Kim, J, Lusczek, E, Remick, DG, Bistrian, B, Burke, P
The journal of trauma and acute care surgery. 2022;(2):255-265
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Abstract
BACKGROUND There is a lack of consensus regarding the optimal nutritional support for trauma patients. We hypothesize that early postinjury metabolic support focusing on adequate protein would modify the metabolic signature and alter the inflammatory environment for critically ill trauma patients. METHODS We conducted a prospective randomized controlled pilot trial for adult patients admitted to the surgical intensive care unit following traumatic injury. Patients were randomized to receive early metabolic support (EMS) (peripheral amino acid infusions) or standard of care (enteral nutrition as soon as feasible). Routine laboratory assessments, nitrogen balance, cytokines, and metabolomic analyses were assessed at baseline and day 5 after intervention. RESULTS A total of 42 trauma patients were randomized into well-balanced groups with similar age (32 years), Injury Severity Score (25), and body mass index (27.4 kg/m2). Early metabolic support provided significantly more protein (1.43 g/kg vs. 0.35 g/kg; p < 0.0001) and more calories (12.6 kcal/kg vs. 7.5 g/kg; p = 0.0012) over the first 5 days as compared with the standard of care. Early metabolic support modified protein catabolism and synthesis as demonstrated by a larger median negative nitrogen balance (-16.3 g vs. -5.3 g; p = 0.03) and a unique metabolomic profile at day 5. The biochemical profile of patients who received EMS was defined by greater declines in circulating levels of stress hormone precursors and increased levels of amino acids. The inflammatory response following EMS resulted in a greater decrease in interleukin-1B (p = 0.02) and increase in soluble interleukin-6 receptor (p = 0.01) between baseline and day 5 as compared with the standard of care. The EMS group had a decreased length of stay (15 vs. 22 days) and decreased surgical intensive care unit length of stay (8 vs. 9 days); however, this disappeared after adjustment for Injury Severity Score in this small population. CONCLUSIONS Early metabolic support with amino acid is safe, modifies metabolism, and may downregulate the inflammatory state associated with significant trauma, warranting a larger trial to assess for improved outcomes. LEVEL OF EVIDENCE Therapeutic/Care Management; Level II.
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Effect of nutritional support in patients with lower respiratory tract infection: Secondary analysis of a randomized clinical trial.
Baumgartner, A, Hasenboehler, F, Cantone, J, Hersberger, L, Bargetzi, A, Bargetzi, L, Kaegi-Braun, N, Tribolet, P, Gomes, F, Hoess, C, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(4):1843-1850
Abstract
BACKGROUND In polymorbid patients with bronchopulmonary infection, malnutrition is an independent risk factor for mortality. There is a lack of interventional data investigating whether providing nutritional support during the hospital stay in patients at risk for malnutrition presenting with lower respiratory tract infection lowers mortality. METHODS For this secondary analysis of a randomized clinical trial (EFFORT), we analyzed data of a subgroup of patients with confirmed lower respiratory tract infection from an initial cohort of 2028 patients. Patients at nutritional risk (Nutritional Risk Screening [NRS] score ≥3 points) were randomized to receive protocol-guided individualized nutritional support to reach protein and energy goals (intervention group) or standard hospital food (control group). The primary endpoint of this analysis was all-cause 30-day mortality. RESULTS We included 378 of 2028 EFFORT patients (mean age 74.4 years, 24% with COPD) into this analysis. Compared to usual care hospital nutrition, individualized nutritional support to reach caloric and protein goals showed a similar beneficial effect of on the risk of mortality in the subgroup of respiratory tract infection patients as compared to the main EFFORT trial (odds ratio 0.47 [95%CI 0.17 to 1.27, p = 0.136] vs 0.65 [95%CI 0.47 to 0.91, p = 0.011]) with no evidence of a subgroup effect (p for interaction 0.859). Effects were also similar among different subgroups based on etiology and type of respiratory tract infection and for other secondary endpoints. CONCLUSION This subgroup analysis from a large nutrition support trial suggests that patients at nutritional risk as assessed by NRS 2002 presenting with bronchopulmonary infection to the hospital likely have a mortality benefit from individualized inhospital nutritional support. The small sample size and limited statistical power calls for larger nutritional studies focusing on this highly vulnerable patient population. CLINICAL TRIAL REGISTRATION Registered under ClinicalTrials.gov Identifier no. NCT02517476.
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Medical high-protein nutrition therapy and loss of muscle mass in adult ICU patients: A randomized controlled trial.
Dresen, E, Weißbrich, C, Fimmers, R, Putensen, C, Stehle, P
Clinical nutrition (Edinburgh, Scotland). 2021;(4):1562-1570
Abstract
BACKGROUND & AIMS The degradation of muscle mass and loss of functional proteins due to catabolism are associated with adverse outcomes in critically ill patients. While an adequate supply of protein within a medical nutrition concept is suggested to minimize proteolysis, the specificities on appropriate dosage and timing are still under debate. The current study aimed to evaluate the effect of two different quantities of protein as part of a standardized energetically controlled nutrition therapy for the preservation of muscle mass in the later phase of critical illness. METHODS A randomized controlled trial was conducted in 42 critically ill patients (age 65 ± 15; 12 females; SAPS 45 ± 11; TISS 20 ± 7; SOFA-score 7 ± 3). The subjects were randomly assigned to either the intervention (1.8 g protein/kg body weight [BW]/d) or standard (1.2 g protein/kg BW/d) group. Nutrient supply via enteral and/or parenteral nutrition was calculated based on the individual energy expenditure measured by indirect calorimetry and target protein content. Quadriceps muscle layer thickness (QMLT) was observed through sonography at inclusion, and during the follow-up period, two and four weeks after inclusion. The measurement points were fixed on two sides at the midpoint and two-thirds between the anterior superior iliac spine and top of the patella. The data were analyzed descriptively wherein chi-squared tests or unpaired two-samle t-tests checked group differences. Daily changes in muscle mass were estimated using a linear mixed model. All data are shown as the mean ± standard deviation (SD). RESULTS Actual protein intake reached 1.5 ± 0.5 g and 1.0 ± 0.5 g/kg BW/d in the intervention and standard group, respectively. Mean values of all measurements of QMLT at inclusion (day 13 ± 2 after ICU admission) were 13.5 ± 7.4 mm and 13.4 ± 7.1 mm in the intervention and standard group, respectively (P = 0.967). In both the groups, QMLT decreased over time (P < 0.001), while the estimated mean values of daily QMLT changes were -0.15 ± 0.08 mm (intervention) and -0.28 ± 0.08 mm (standard) without significant between-group differences (intervention effect, P = 0.368; time x intervention effect, P = 0.242). Illness scores and clinical outcomes showed no group differences. CONCLUSION In this single-center trial the increased amounts of protein (1.5 g vs. 1.0 g/kg BW/d) provided through medical nutrition therapy in the late phase of critical illness did not achieve a statistically significant impact on the loss of muscle mass in long-term immobilized ICU patients. Larger multi-center trials are needed to evaluate whether observed numerical differences in muscle mass could be a true finding, and will translate into improved clinical outcomes. TRIAL REGISTRATION German Clinical Trials Register (http://www.drks.de/), DRKS-ID: DRKS00013594.
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A Novel Substrate-Inspired Fluorescence-Based Albumin Detection Improves Assessment of Clinical Outcomes in Hemodialysis Patients Receiving a Nursing Nutrition Intervention.
You, L, Wang, X, Wang, W
Medical science monitor : international medical journal of experimental and clinical research. 2021;:e930257
Abstract
BACKGROUND Albumin level does not precisely reflect nutritional status. We aimed to investigate the impact of a nutrition intervention on hemodialysis patients by use of fluorescence-based plasma albumin (FPA) detection. MATERIAL AND METHODS Eighty patients underwent maintenance hemodialysis for more than half a year and had a mean albumin <3.5 g/dL for over 3 months. The subjects were randomly divided into either a Control Group (CG) or an Intervention Group (IG). The IG received nutritional supplementation, and the CG group received routine nutritional support for 12 months. FPA and plasma albumin (PA) concentrations were measured. The fluorescence probe 1,3-Dichloro-7-hydroxy-9,9-dimethyl-2(9H)-acridone methyl biphenyl benzoate was used in FPA detection. Quality of life was estimated using WHOQOL-BREF (Quality of Life Scale developed through the World Health Organization), the 36-Item Short-Form Survey (SF-36), and the 6-minute walking test (6MWT). RESULTS After a 6-month and a 12-month intervention, PA and FPA concentrations increased, and the increase in FPA concentration was higher than that of PA in the IG group (P<0.05). Comparatively, the parameters of quality of life and 6MWT were improved in the IG group (P<0.05) but there were only minor changes in the CG group (P>0.05). There is an obvious association between the changes in FPA concentration and the parameters of quality of life and 6MWT but not PA. CONCLUSIONS Use of the fluorescence probe improves the detection sensitivity of plasma albumin and provides a potential method to assess clinical outcomes in hemodialysis patients.
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Effectiveness of early versus delayed exercise and nutritional intervention on segmental body composition of sarcopenic elders - A randomized controlled trial.
Chang, KV, Wu, WT, Huang, KC, Han, DS
Clinical nutrition (Edinburgh, Scotland). 2021;(3):1052-1059
Abstract
BACKGROUND & AIMS Although resistance training with nutritional support is considered the best treatment option for sarcopenia, the importance of home-based exercise should not be overlooked. For managing sarcopenia, a fundamental issue is whether home-based exercise or a supervised training program should be administered first. Therefore, the present trial aimed to compare the effect of early versus delayed exercise intervention with nutritional support on the physical performance and body composition of sarcopenic elders. METHODS The study was a randomized controlled trial using a parallel-group design. Each group received two therapeutic periods lasted 12 weeks with an interval of 2 weeks in between. Physical performance and body composition were assessed at baseline and immediately following the end of the first and second phases. One phase included hospital-based resistance training and nutritional support (amino acid, calcium, and vitamin D3), whereas the other phase included home-based exercise. In the early intervention group, supervised exercise and nutrition supplementation were administered first followed by home-based exercise, whereas the sequence was reversed in the delayed intervention group. The influence of intervention sequence on the outcome variables was examined using a 3∗2 repeated-measures analysis of variance. The primary endpoints were defined as changes in lean mass and related physical function (grip strength and gait speed) over 12 and 26 weeks of interventions. RESULTS A total of 57 sarcopenic elders were randomly assigned to the early (n = 29) and delayed (n = 28) intervention groups. Among the primary endpoints, the only significant group-time interaction was recognized on the changes of lower extremity lean mass (p = 0.039). The early intervention was associated with an earlier increase in lower extremity lean mass (770.8 g, 95% confidence interval (CI), 564.8 g-976.9 g) than delayed intervention (294.2 g, 95% CI, -42.13 to 630.5 g) which was evident from the between-group comparison between baseline and the 1st follow-up (p = 0.016). No significant effect of group-time interaction was observed on the physical performance and other components of body composition. CONCLUSIONS Early exercise and nutritional intervention may be helpful in an earlier restoration of lower extremity muscle mass but not physical function in sarcopenic elders. When designing a rehabilitation program for patients with sarcopenia, resistance training with nutrition support can be prescribed first for the rapid enlargement of the muscle volume, and structuralized home-based exercise can be administered subsequently to preserve the prior intervention effect. TRIAL REGISTRATION ClinicalTrials.gov (NCT02779088).
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Reduced mortality risk in malnourished hospitalized older adult patients with COPD treated with a specialized oral nutritional supplement: Sub-group analysis of the NOURISH study.
Deutz, NE, Ziegler, TR, Matheson, EM, Matarese, LE, Tappenden, KA, Baggs, GE, Nelson, JL, Luo, M, Hegazi, R, Jonnalagadda, SS, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(3):1388-1395
Abstract
BACKGROUND Hospitalized, malnourished older adults with chronic obstructive pulmonary disease (COPD) have an elevated risk of readmission and mortality. OBJECTIVE Post-hoc, sub-group analysis from the NOURISH study cohort examined the effect of a high-protein oral nutritional supplement (ONS) containing HMB (HP-HMB) in malnourished, hospitalized older adults with COPD and to identify predictors of outcomes. METHODS The NOURISH study (n = 652) was a multicenter, randomized, placebo-controlled, double-blind trial. The COPD subgroup (n = 214) included hospitalized, malnourished (based on Subjective Global Assessment), older adults (≥65 y), with admission diagnosis of COPD who received either standard-of-care plus HP-HMB (n = 109) or standard-of-care and a placebo supplement (n = 105) prescribed 2 servings/day from within 3 days of hospital admission (baseline) and up to 90 days after discharge. The primary study outcome was a composite endpoint of incidence of death or non-elective readmission up to 90-day post-discharge, while secondary endpoints included changes in hand-grip strength, body weight, and nutritional biomarkers over time. Categorical outcomes were analyzed using Cochran-Mantel-Haenszel tests, longitudinal data by repeated measures analysis of covariance; and changes from baseline by analysis of covariance. p-values ≤ 0.05 were considered statistically significant. Multivariate logistic regression was used to model predictors of the primary outcome and components. RESULTS In patients with COPD, 30, 60, and 90-day hospital readmission rate did not differ, but in contrast, 30, 60, and 90-day mortality risk was approximately 71% lower with HP-HMB supplementation relative to placebo (1.83%, 2.75%, 2.75% vs. 6.67%, 9.52% and 10.48%, p = 0.0395, 0.0193, 0.0113, resp.). In patients with COPD, compared to placebo, intake of HP-HMB resulted in a significant increase in handgrip strength (+1.56 kg vs. -0.34 kg, p = 0.0413) from discharge to day 30; increased body weight from baseline to hospital discharge (0.66 kg vs. -0.01 kg, p < 0.05) and, improvements in blood nutritional biomarker concentrations. The multivariate logistic regression predictors of the death, readmission or composite endpoints in these COPD patients showed that participants who were severely malnourished (p = 0.0191) and had a Glasgow prognostic score (GPS) Score of 1 or 2 had statistically significant odds of readmission or death (p = 0.0227). CONCLUSIONS Among malnourished, hospitalized patients with COPD, supplementation with HP-HMB was associated with a markedly decreased mortality risk, and improved handgrip strength, body weight, and nutritional biomarkers within a 90-day period after hospital discharge. This post-hoc, subgroup analysis highlights the importance of early identification of nutritional risk and administration of high-protein ONS in older, malnourished patients with COPD after hospital admission and continuing after hospital discharge.
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Effects of using the MyFood decision support system on hospitalized patients' nutritional status and treatment: A randomized controlled trial.
Paulsen, MM, Paur, I, Gjestland, J, Henriksen, C, Varsi, C, Tangvik, RJ, Andersen, LF
Clinical nutrition (Edinburgh, Scotland). 2020;(12):3607-3617
Abstract
BACKGROUND & AIMS Compliance to guidelines for disease-related malnutrition is documented as poor. The practice of using paper-based dietary recording forms with manual calculation of the patient's nutritional intake is considered cumbersome, time-consuming and unfeasible among the nurses and does often not lead to appropriate nutritional treatment. We developed the digital decision support system MyFood to deliver a solution to these challenges. MyFood is comprised of an app for patients and a website for nurses and includes functions for dietary recording, evaluation of intake compared to requirements, and a report to nurses including tailored recommendations for nutritional treatment and a nutritional care plan for documentation. The study aimed to investigate the effects of using the MyFood decision support system during hospital stay on adult patients' nutritional status, treatment and hospital length of stay. The main outcome measure was weight change. METHODS The study was a parallel-arm randomized controlled trial. Patients who were allocated to the intervention group used the MyFood app during their hospital stay and the nurses were encouraged to use the MyFood system. Patients who were allocated to the control group received routine care. RESULTS We randomly assigned 100 patients (51.9 ± 14 y) to the intervention group (n = 49) and the control group (n = 51) between August 2018 and February 2019. Losses to follow-up were n = 5 in the intervention group and n = 1 in the control group. No difference was found between the two groups with regard to weight change. Malnutrition risk at discharge was present in 77% of the patients in the intervention group and 94% in the control group (p = 0.019). Nutritional treatment was documented for 81% of the patients in the intervention group and 57% in the control group (p = 0.011). A nutritional care plan was created for 70% of the intervention patients compared to 16% of the control patients (p < 0.001). CONCLUSIONS The intervention had no effect on weight change during hospital stay. A higher proportion of the patients in the control group was malnourished or at risk of malnutrition at hospital discharge compared to the patients in the intervention group. The documentation of nutritional intake, treatment and nutritional care plans was higher for the patients using the MyFood system compared to the control group. This trial was registered at clinicaltrials.gov (NCT03412695).
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Safety, feasibility, and effect of an enhanced nutritional support pathway including extended preoperative and home enteral nutrition in patients undergoing enhanced recovery after esophagectomy: a pilot randomized clinical trial.
Liu, K, Ji, S, Xu, Y, Diao, Q, Shao, C, Luo, J, Zhu, Y, Jiang, Z, Diao, Y, Cong, Z, et al
Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus. 2020;(2)
Abstract
The aims of this pilot study are to evaluate the feasibility, safety, and effectiveness of conducting an enhanced nutritional support pathway including extended preoperative nutritional support and one month home enteral nutrition (HEN) for patients who underwent enhanced recovery after esophagectomy. We implemented extended preoperative nutritional support and one month HEN after discharge for patients randomized into an enhanced nutrition group and implemented standard nutritional support for patients randomized into a conventional nutrition group. Except the nutritional support program, both group patients underwent the same standardized enhanced recovery after surgery programs of esophagectomy based on published guidelines. Patients were assessed at preoperative day, postoperative day 7 (POD7), and POD30 for perioperative outcomes and nutritional status. To facilitate the determination of an effect size for subsequent appropriately powered randomized clinical trials and assess the effectiveness, the primary outcome we chose was the weight change before and after esophagectomy. Other outcomes including body mass index (BMI), lean body mass (LBM), appendicular skeletal muscle mass index (ASMI), nutrition-related complications, and quality of life (QoL) were also analyzed. The intention-to-treat analysis of the 50 randomized patients showed that there was no significant difference in baseline characteristics. The weight (-2.03 ± 2.28 kg vs. -4.05 ± 3.13 kg, P = 0.012), BMI (-0.73 ± 0.79 kg/m2 vs. -1.48 ± 1.11 kg/m2, P = 0.008), and ASMI (-1.10 ± 0.37 kg/m2 vs. -1.60 ± 0.66 kg/m2, P = 0.010) loss of patients in the enhanced nutrition group were obviously decreased compared to the conventional nutrition group at POD30. In particular, LBM (48.90 ± 9.69 kg vs. 41.96 ± 9.37 kg, p = 0.031) and ASMI (7.56 ± 1.07 kg/m2 vs. 6.50 ± 0.97 kg/m2, P = 0.003) in the enhanced nutrition group were significantly higher compared to the conventional nutrition group at POD30, despite no significant change between pre- and postoperation. In addition, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 scores revealed that enhanced nutritional support improved the QoL of patients in physical function (75.13 ± 9.72 vs. 68.33 ± 7.68, P = 0.009) and fatigue symptom (42.27 ± 9.93 vs. 49.07 ± 11.33, P = 0.028) compared to conventional nutritional support. This pilot study demonstrated that an enhanced nutritional support pathway including extended preoperative nutritional support and HEN was feasible, safe, and might be beneficial to patients who underwent enhanced recovery after esophagectomy. An appropriately powered trial is warranted to confirm the efficacy of this approach.
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A prospective randomized controlled trial on the value of prophylactic oral nutritional supplementation in locally advanced nasopharyngeal carcinoma patients receiving chemo-radiotherapy.
Huang, S, Piao, Y, Cao, C, Chen, J, Sheng, W, Shu, Z, Hua, Y, Jiang, F, Hu, Q, Chen, X, et al
Oral oncology. 2020;:105025
Abstract
OBJECTIVES We investigated the effect of prophylactic oral nutrition supplements (ONS) in locally advanced nasopharyngeal carcinoma patients receiving neoadjuvant chemotherapy and concurrent chemoradiotherapy (CCRT). METHODS Eligible patients were randomly assigned to an intervention or control group. Patients in the intervention group were supported with prophylactic ONS from the beginning of CCRT. The control group received nutritional support only when necessary. Bodyweight, hematological indexes, nutritional status, and quality of life were measured at baseline and before, during, and after RT. RESULTS We evaluated 114 patients from October 2016 to May 2018. More than half of patients experienced significant weight loss during CCRT, which continued for three months after radiotherapy (RT). Compared to baseline, the rate of weight loss ≥ 5% before, during, at the end of RT, and one and three months after RT were 3.5%, 28.9%, 51.8%, 61.4%, and 61.4%, respectively. Nutritional status and global health status scores progressively decreased during treatment. The rate of RT interruption was higher in the control group than in the intervention group (7.14% vs. 0%, χ2 = 4.29, P = 0.04). More patients experienced concurrent chemotherapy interruption in the control group than in the intervention group (28.57% vs 10.34%, χ2 = 6.08, P = 0.01). There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups. CONCLUSIONS Malnutrition and weight loss progressively increased during treatment. Prophylactic ONS can improve tolerance to CCRT, but it offers no advantage on short-term weight loss or nutritional assessment scores.
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Cost-effectiveness of an exercise and nutritional intervention versus usual nutritional care during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial.
Perrier, L, Foucaut, AM, Morelle, M, Touillaud, M, Kempf-Lépine, AS, Heinz, D, Gomez, F, Meyrand, R, Baudinet, C, Berthouze, S, et al
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2020;(6):2829-2842
Abstract
We undertook a cost-effectiveness analysis (CEA) to compare an exercise and nutritional program with the usual nutritional care concomitant to adjuvant chemotherapy in localized breast cancer patients. The CEA was designed as part of the interventional, controlled, randomized, single-center, open-label PASAPAS study. Breast cancer patients receiving first-line adjuvant chemotherapy at a French Comprehensive Cancer Center were randomized 2:1 to a 6-month exercise program of supervised indoor and outdoor group sessions in addition to usual nutritional care (exercise arm) or a usual nutritional care group receiving dietary and physical activity counseling (control arm). Costs were assessed from the French national insurance perspective (in Euros, 2012). Incremental cost-effectiveness ratios (ICERs) were calculated for four criteria: body mass index, waist circumference, body fat percentage, and estimated aerobic capacity. Uncertainty around the ICERs was captured by a probabilistic analysis using a non-parametric bootstrap method. The analysis was based on 60 patients enrolled between 2011 and 2013. Average intervention costs per participant were €412 in the exercise arm (n = 41) and €117 (n = 19) in the control arm. Total mean costs were €17,344 (standard deviation 9,928) and €20,615 (standard deviation 14,904), respectively, did not differ significantly (p = 0.51). The 6-month exercise program was deemed to be cost-effective compared with usual care for the estimated aerobic capacity. Multicenter randomized studies with long-term costs and outcomes should be done to provide additional evidence. Clinical trial: The PASAPAS study is registered under ClinicalTrials.gov. Trial registration ID: NCT01331772.