Functional, cognitive, and nutritional decline in 435 elderly nursing home residents after the first wave of the COVID-19 Pandemic.

PURPOSE: Many institutionalized older people have died during the first wave of COVID-19. Other related consequences have not yet been described objectively. The aim of this study was to compare functional, cognitive, and nutritional status before and after the first wave among nursing home residents, in both COVID-19 and non-COVID-19 patients. METHODS: Older adults institutionalized in four nursing homes were assessed from May to June 2020, by a geriatric multidisciplinary team in collaboration with the nursing homes staff. Comprehensive geriatric assessment was performed including functional, cognitive, and nutritional variables before and after the first wave of the pandemic. Data from residents with positive results for microbiological testing for SARS-CoV-2 were compared with those who did not. RESULTS: 435 nursing home residents were included. The median age was 86.77 ± 8.5 years, 78.4% were women. 190 (43.9%) tested positive for coronavirus. Functional decline after the first wave was detected in 20.2% according to the Barthel Index and in 18.5% according to functional ambulation categories, p < 0.001. Cognitive status worsened by 22 and 25.9% according to the global deterioration scale (p < 0.001) and Lobo's Mini-Examen Cognoscitivo (p 0.01), respectively. Onset of depressive symptoms was found in 48% (p < 0.001). The prevalence of malnutrition increased by 36.8 and 38.4% lost weight. When comparing the functional, cognitive, and nutritional decline between COVID-19 and non-COVID-19 patients no clinical or statistically significant differences were found except for the presence of prior malnutrition, higher in the COVID-19 group. CONCLUSION: We observed a significative functional, cognitive, and nutritional decline in institutionalized elderly after the first wave of COVID-19. These results may be caused by the lockdown itself, since no differences have been found between COVID-19 and non-COVID-19 patients. According to these results, interventions are necessary during social isolation or confinement to prevent systemic decline in the elderly.

Guía de práctica clínica sobre el diagnóstico y tratamiento de la hiponatremia / Hyponatraemia diagnosis and treatment clinical practice guidelines

La hiponatremia se define como una concentración sérica de sodio <135mmol/L y es el trastorno hidroelectrolítico más frecuente en la práctica clínica. La hiponatremia puede causar un amplio espectro de síntomas clínicos, desde sutiles hasta graves o incluso mortales, y se asocia con aumento de la morbimortalidad y prolongación de la estancia hospitalaria. A pesar de ello, el manejo de los pacientes con hiponatremia sigue siendo problemático. La prevalencia de hiponatremia en enfermedades muy diferentes y su manejo por muy diversos especialistas han fomentado la existencia de protocolos de diagnóstico y tratamiento muy diversos, que varían con la especialidad y la institución. La Sociedad Europea de Medicina Intensiva (ESICM), la Sociedad Europea de Endocrinología (ESE) y la Asociación Renal Europea-Asociación Europea de Diálisis y Trasplante (ERA-EDTA), representada por la European Renal Best Practices (ERBP), han desarrollado la guía de práctica clínica sobre el enfoque diagnóstico y tratamiento de la hiponatremia como una empresa conjunta de las 3 sociedades que representan a los especialistas con un interés natural en la hiponatremia, a fin de ofrecer una visión común y holística del abordaje del problema. Además de ofrecer un enfoque riguroso en la metodología y la evaluación de la evidencia, el documento está centrado en resultados importantes para el paciente y en facilitar una herramienta útil para los médicos en la práctica clínica cotidiana. Presentamos ahora una versión abreviada de las recomendaciones y sugerencias sobre el diagnóstico y el tratamiento de la hiponatremia recogidas en la guía complete (AU)

Hyponatremia, defined as a serum sodium concentration <135mmol/l, is the most common water-electrolyte imbalance encountered in clinical practice. It can lead to a wide spectrum of clinical symptoms, from mild to severe or even life threatening, and is associated with increased mortality, morbidity and length of hospital stay. Despite this, the management of hyponatremia patients remains problematic. The prevalence of hyponatremia in a wide variety of conditions and the fact that hyponatremia is managed by clinicians with a broad variety of backgrounds have fostered diverse institution- and specialty-based approaches to diagnosis and treatment. To obtain a common and holistic view, the European Society of Intensive Care Medicine (ESICM), the European Society of Endocrinology (ESE) and the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA), represented by European Renal Best Practice (ERBP), have developed clinical practice guidelines on the diagnostic approach and treatment of hyponatremia as a joint venture of 3 societies representing specialists with a natural interest in hyponatremia. In addition to a rigorous approach to the methodology and evaluation of the evidence, the document focuses on patient-positive outcomes and on providing a useful tool for clinicians involved in everyday practice. In this article, we present an abridged version of the recommendations and suggestions for the diagnosis and treatment of hyponatremia extracted from the full guide (AU)

Hyponatraemia diagnosis and treatment clinical practice guidelines. / Guía de práctica clínica sobre el diagnóstico y tratamiento de la hiponatremia.

Hyponatremia, defined as a serum sodium concentration <135mmol/l, is the most common water-electrolyte imbalance encountered in clinical practice. It can lead to a wide spectrum of clinical symptoms, from mild to severe or even life threatening, and is associated with increased mortality, morbidity and length of hospital stay. Despite this, the management of hyponatremia patients remains problematic. The prevalence of hyponatremia in a wide variety of conditions and the fact that hyponatremia is managed by clinicians with a broad variety of backgrounds have fostered diverse institution- and specialty-based approaches to diagnosis and treatment. To obtain a common and holistic view, the European Society of Intensive Care Medicine (ESICM), the European Society of Endocrinology (ESE) and the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA), represented by European Renal Best Practice (ERBP), have developed clinical practice guidelines on the diagnostic approach and treatment of hyponatremia as a joint venture of 3societies representing specialists with a natural interest in hyponatremia. In addition to a rigorous approach to the methodology and evaluation of the evidence, the document focuses on patient-positive outcomes and on providing a useful tool for clinicians involved in everyday practice. In this article, we present an abridged version of the recommendations and suggestions for the diagnosis and treatment of hyponatremia extracted from the full guide.

2012 ERA-EDTA Registry Annual Report: cautious optimism on outcomes, concern about persistent inequalities and data black-outs.

The 2012 ERA-EDTA Registry Annual Report contains both good news and bad news. On the bright side, the 2-year survival of patients starting renal replacement therapy (RRT) for chronic kidney disease (CKD), on dialysis or receiving a living-related kidney transplantation, has progressively increased to 82.2, 79.7 and 98.3%, respectively, whereas for cadaveric kidney transplantation it remains stable (96.0-96.1%). On the dark side, inequalities persist between European citizens in access to renal transplantation and in incidence and prevalence of RRT. Living in Greece, Belgium (French- or Dutch-speaking) or Portugal (the GBP countries) is associated with higher chances of initiating RRT than living in other European countries. The adjusted RRT incidence for GBP countries was 188, 201-174 and 220* (* unadjusted) pmp in 2012, respectively (versus 122, 114 and 97 pmp in the Netherlands or two Spanish regions bordering Portugal). In lower income countries, a low RRT incidence may represent lack of access to needed healthcare (e.g. Montenegro 26 pmp). However, how can the high incidence and prevalence of RRT in the GBP countries be explained? Do GBP citizens have access to RRT that is denied, rejected or considered unnecessary in other high income countries? Does the GBP healthcare system fail to prevent progression of CKD? Do local genetic or environmental factors favour CKD progression? Unravelling the underlying reasons is an urgent research need: only an understanding of the causes will allow correction of the problem. Unavailability of data from some large countries (e.g. Germany and Italy) is not helpful.

Individualization of dialysate calcium concentration according to baseline pre-dialysis serum calcium.

BACKGROUND: A positive calcium balance may contribute to vascular calcification, while a negative balance increases iPTH. We explored the impact of different dialysate calcium concentrations on bone and mineral metabolism parameters according to pre-dialysis serum calcium levels. RESULTS: Fifty-six hemodialysis patients were dialyzed with 3.0 or 2.5 mEq/l dialysate [calcium] in a crossover study of two weeks. Bone mineral metabolites were measured prior to and following the hemodialysis session. A 3.0 mEq/l dialysate [calcium] increased more post-dialysis total calcium and ionized calcium than 2.5 mEq/l dialysate [calcium]. The mildest dialysis-induced changes in calcium and PTH were observed in patients with pre-dialysis serum calcium <8.75 mg/dl dialyzed with 2.5 mEq/l dialysate [calcium] and in patients with pre-dialysis serum calcium >9.15 mg/dl dialyzed with 3.0 mEq/l calcium dialysate. CONCLUSION: In conclusion, the individualization of dialysate calcium concentration according to baseline pre-dialysis serum calcium may prevent major excursions in post-dialysis serum calcium and iPTH levels. SHORT SUMMARY: High calcium dialysate may increase serum calcium in hemodialysis patients, while low dialysate calcium may increase PTH. Individualization of dialysate calcium according to predialysis serum calcium levels may prevent or decrease unwanted excursions of both serum calcium and PTH.

Deferasirox nephrotoxicity-the knowns and unknowns.

In 2005, the oral iron chelator deferasirox was approved by the FDA for clinical use as a first-line therapy for blood-transfusion-related iron overload. Nephrotoxicity is the most serious and frequent adverse effect of deferasirox treatment. This nephrotoxicity can present as an acute or chronic decrease in glomerular filtration rate (GFR). Features of proximal tubular dysfunction might also be present. In clinical trials and observational studies, GFR is decreased in 30-100% of patients treated with deferasirox, depending on dose, method of assessment and population studied. Nephrotoxicity is usually nonprogressive and/or reversible and rapid iron depletion is one of several risk factors. Scarce data are available on the molecular mechanisms of nephrotoxicity and the reasons for the specific proximal tubular sensitivity to the drug. Although deferasirox promotes apoptosis of cultured proximal tubular cells, the trigger has not been well characterized. Observational studies are required to track current trends in deferasirox prescription, assess the epidemiology of deferasirox nephrotoxicity in routine clinical practice, explore the effect on outcomes of various monitoring and dose-adjustment protocols and elucidate the long-term consequences of the different features of nephrotoxicity. Deferasirox nephrotoxicity can be more common in the elderly; thus, specific efforts should be dedicated to investigate the effect of deferasirox use in this group of patients.

Next-generation phosphate binders: focus on iron-based binders.

Phosphate excess is associated with increased mortality in patients with chronic kidney disease (CKD) and has recently been linked to accelerated aging. Oral phosphate binders are prescribed to patients with CKD to prevent absorption of dietary phosphate. Currently available binders have been associated with impaired outcomes (calcium-based binders) or are expensive (non-calcium-based binders). Iron-based phosphate binders represent a new class of phosphate binders. Four iron-based phosphate binders have undergone testing in clinical trials. The development of fermagate and SBR759 is currently on hold due to suboptimal and adverse effect profiles in at least some clinical trials. Ferric citrate and sucroferric oxyhydroxide (PA21) are at different stages of application for regulatory approval after being found safe and efficacious in decreasing serum phosphate. Iron from ferric citrate is more readily absorbed than that from sucroferric oxyhydroxide. Sucroferric oxyhydroxide was launched in the USA in 2014 for the treatment of hyperphosphatemia in adult dialysis patients. Ferric citrate may be more suited for chronic treatment of hyperphosphatemia in CKD patients requiring iron supplements but its use may have to be limited in time because of potential for iron overload in patients not needing iron or not receiving erythropoiesis-stimulating agents. In contrast, sucroferric oxyhydroxide may be more suited for hyperphosphatemic CKD patients not requiring iron supplements.

Osteoprotegerin and kidney disease.

Vascular calcification in chronic kidney disease (CKD) patients is associated to increased mortality. Osteoprotegerin (OPG) is a soluble tumor necrosis factor (TNF) superfamily receptor that inhibits the actions of the cytokines receptor activator of nuclear factor kappa-B ligand (RANKL) and TNF-related apoptosis-inducing ligand (TRAIL) by preventing their binding to signaling receptors in the cell membrane. OPG-deficient mice display vascular calcification while OPG prevented calcification of cultured vascular smooth muscle cells and protected kidney cells from TRAIL-induced death. OPG may be a biomarker in patients with kidney disease. Circulating OPG is increased in predialysis, dialysis and transplant CKD patients and may predict vascular calcification progression and patient survival. By contrast, circulating OPG is decreased in nephrotic syndrome. In addition, free and exosome-bound urinary OPG is increased in human kidney disease. Increased urinary OPG has been associated with lupus nephritis activity. Despite the association of high OPG levels with disease, experimental functional information available suggests that OPG might be protective in kidney disease and in vascular injury in the context of uremia. Thus, tissue injury results in increased OPG, while OPG may protect from tissue injury. Recombinant OPG was safe in phase I randomized controlled trials. Further research is needed to fully define the therapeutic and biomarker potential of OPG in patients with kidney disease.

Macrophages and recently identified forms of cell death.

Recent advances in cell death biology have uncovered an ever increasing range of cell death forms. Macrophages have a bidirectional relationship with cell death that modulates the immune response. Thus, macrophages engulf apoptotic cells and secrete cytokines that may promote cell death in parenchymal cells. Furthermore, the presence of apoptotic or necrotic dead cells in the microenvironment elicits differential macrophage responses. Apoptotic cells elicit anti-inflammatory responses in macrophages. By contrast macrophages may undergo a proinflammatory form of cell death (pyroptosis) in response to damage-associated molecular patterns (DAMPs) released from necrotic cells and also in response to pathogen-associated molecular patterns (PAMPs). Pyroptosis is a recently identified form of cell death that occurs predominantly in subsets of inflammatory macrophages and is associated to the release of interleukin-1ß (IL-1ß) and IL-18. Deregulation of these processes may result in disease. Thus, failure of macrophages to engulf apoptotic cells may be a source of autoantigens in autoimmune diseases, excessive macrophage release of proapoptotic factors or sterile pyroptosis may contribute to tissue injury and failure of pathogen-induced pyroptosis may contribute to pathogen survival. Ongoing research is exploring the therapeutic opportunities resulting this new knowledge.

Pentoxifylline decreases serum levels of tumor necrosis factor alpha, interleukin 6 and C-reactive protein in hemodialysis patients: results of a randomized double-blind, controlled clinical trial.

AIM: The aim of this study was to compare the effect of pentoxifylline versus placebo on serum concentrations of tumor necrosis factor-alpha (TNF-α), interleukin 6 (IL-6) and C-reactive protein (CRP) of hemodialysis (HD) patients. METHODS: This is a randomized double-blind, controlled clinical trial. HD patients without infection or drugs with anti-inflammatory effect were randomly allocated to a study (n = 18, pentoxifylline 400 mg/day) or control (n = 18, placebo) group; all patients had arteriovenous fistula. Besides clinical and laboratory monthly assessments, serum TNF-α and IL-6 (ELISA) and CRP (nephelometry) were measured at 0, 2 and 4 months. RESULTS: All the inflammation markers significantly (P < 0.05) decreased in the pentoxifylline group: TNF-α [baseline 0.4 (0-2) versus final 0 (0-0) pg/mL], IL-6 [baseline 9.4 (5-14) versus final 2.9 (2-5) pg/mL] and CRP [baseline 7.1 (3-20) versus final 2.6 (1-8) mg/L], whereas no significant changes were observed in the placebo group: TNF-α [baseline 0 (0-0) versus final 1.2 (0-4) pg/mL], IL-6 [baseline 8.0 (5-11) versus final 8.7 (4-11) pg/mL] and CRP [baseline 4.5 (2-9) versus final 3.8 (3-23) mg/L]. CONCLUSIONS: Pentoxifylline significantly decreased serum concentrations of TNF-α, IL-6 and CRP compared to placebo. Pentoxifylline could be a promising and useful strategy to reduce the systemic inflammation frequently observed in patients on HD.

Dietary micronutrient intake in peritoneal dialysis patients: relationship with nutrition and inflammation status.

OBJECTIVE: To compare dietary intake of micronutrients by peritoneal dialysis (PD) patients according to their nutrition and inflammatory statuses. DESIGN: This cross-sectional study evaluated 73 patients using subjective global assessment, 24-hour dietary recall, and markers of inflammation [C-reactive protein (CRP), tumor necrosis factor α, and interleukin 6]. RESULTS: Half the patients had an inadequate micronutrient intake. Compared with dietary reference intakes, malnourished patients had lower intakes of iron (11 mg) and of vitamins C (45 mg) and B6 (0.8 mg). Malnourished and well-nourished patients both had lower intakes of sodium (366 mg, 524 mg respectively), potassium (1555 mg, 1963 mg), zinc (5 mg, 7 mg), calcium (645 mg, 710 mg), magnesium (161 mg, 172 mg), niacin (8 mg, 9 mg), folic acid (0.14 mg, 0.19 mg), and vitamin A (365 µg, 404 µg). Markers of inflammation were higher in malnourished than in well-nourished subjects. Compared with patients in lower quartiles, patients in the highest CRP quartile had lower intakes (p < 0.05) of sodium (241 mg vs 404 mg), calcium (453 mg vs 702 mg), vitamin B2 (0.88 mg vs 1.20 mg), and particularly vitamin A (207 µg vs 522 µg). CONCLUSIONS: Among PD patients, half had inadequate dietary intakes of iron, zinc, calcium and vitamins A, B6, C, niacin, and folic acid. Lower micronutrient intakes were associated with malnutrition and inflammation. Patients with inflammation had lower intakes of sodium, calcium, and vitamins A and B2. Micronutrient intake must be investigated in various populations so as to tailor adequate supplementation.

Bowel bacterial overgrowth as another cause of malnutrition, inflammation, and atherosclerosis syndrome in peritoneal dialysis patients.

Bowel bacterial overgrowth syndrome (BBOS) is an important cause of gastrointestinal (GI) abnormalities. Proinflammatory cytokines (PICs) are excessively produced and accumulate because of kidney failure in dialysis patients who experience chronic infections such as BBOS. We explored the association between GL function, BBOS, and the malnutrition, inflammation, and atherosclerosis (MIA) syndrome. We studied GI malabsorption and maldigestion by analyzing fecal starch, sugar, fat, and nitrogen; intestinal protein permeability (alpha1-antitrypsin fecal clearance); and fecal chymotrypsin. We evaluated BBOS by breath hydrogen test (BHT) after a 3-day fat-and-carbohydrate-overload diet. Positive BHT was present in 10 patients, showing a high prevalence of GI macronutrient malabsorption and maldigestion, and compared with the other patients, the highest plasma levels of tumor necrosis factor alpha and interleukin 6 and lower levels of albumin and prealbumin. Those 10 patients were treated with a combination of several antibiotics, including neomycin, amoxicillin-clavulanate, and quinolones. Between 2 and 3 months later, the BHT, markers of nutrition, and PIC were re-tested. All treated patients showed an improvement in nutrition status and a lesser inflammatory pattern. The BBOS infectious process is found frequently in dialysis patients in association with GI malabsorption and maldigestion, malnutrition, and systemic inflammation. Hyperproduction of PIC because of BBOS induces MIA through a double pathway: GI disorders and deleterious systemic effects.

Conventional nutritional counselling maintains nutritional status of patients on continuous ambulatory peritoneal dialysis in spite of systemic inflammation and decrease of residual renal function.

AIM: To evaluate the effect of nutritional counselling on nutritional status in peritoneal dialysis patients. METHODS: Twenty-nine peritoneal dialysis patients were randomly selected to receive conventional nutritional counselling during 6 months of follow up. All patients had monthly clinical and biochemical evaluations, and assessments of dialysis adequacy, inflammation and nutritional status at 0, 3 and 6 months. RESULTS: Moderate-severe malnutrition decreased 28% whereas normal nutrition increased 23% at final evaluation (non-significant). Calorie and protein intake remained stable throughout the study (baseline vs final, calorie: 24 +/- 8 vs 23 +/- 5 Kcal/kg; protein: 1.1 +/- 0.5 vs 1.0 +/- 0.3 g/Kg, respectively). On the other hand, triceps (16 +/- 6 vs 18 +/- 8 mm) and subscapular (17 +/- 8 vs 20 +/- 5 mm) skinfold thicknesses, and mid-arm circumference (27 +/- 3 vs 28 +/- 3 mm) significantly increased; mid-arm muscle area displayed a non-significant trend to increase (30 +/- 9 vs 31 +/- 9 cm(2)) whereas serum albumin significantly increased at the end of study (2.67 +/- 0.46 vs 2.94 +/- 0.48 g/dL). At final evaluation, median renal creatinine clearance decreased (6.3 (0.8-15.3) vs 2.0 (0.1-6.3) L/week per 1.73 m(2)) whereas interleukin-6 increased (2.33 (1.9-7.0) vs 4.02 (2.1-8.4) pg/mL). CONCLUSION: Even though conventional nutritional counselling, as an isolated measure, did not significantly improve all nutritional parameters, it prevented a greater deterioration during 6 months. Nutritional counselling maintained the nutritional status in spite of a decrease in residual renal function and higher systemic inflammation.

Inflammation in peritoneal dialysis: a Latin-American perspective.

Peritoneal dialysis (PD) patients present an extremely high mortality rate, but the mechanisms mediating the increased risk of mortality observed in this group of patients are still largely unknown, which limits the perspective of effective therapeutic strategies. The leading hypothesis that tries to explain this high mortality risk is that PD patients are exposed to a number of traditional risk factors for cardiovascular disease (CVD) already at the onset of their chronic kidney disease (CKD), since many of these risk factors are common to both CVD and CKD. Of particular importance, chronic inflammation recently emerged as an important novel risk factor related to multiple complications of CKD. There are many stimuli of the inflammatory response in CKD patients, such as fluid overload, decreased cytokine clearance, presence of uremia-modified proteins, presence of chronic infections, metabolic disturbances (including hyperglycemia), obesity. Many of these factors are related to PD. Latin America has made some progress in economic issues; however, a large portion of the population is still living in poverty, in poor sanitary conditions, and with many health-related issues, such as an increasing elderly population, low birth weights, and increasingly high energy intake in the adult population, which, in combination with changes in lifestyle, has provoked an increase in the prevalence of obesity, diabetes, and CVD. Therefore, in Latin America, there seems to be a peculiar situation combining high prevalence of low education level, poor sanitary conditions, and poverty with increases in obesity, diabetes, and sedentary lifestyle. Since inflammation and mortality risk are intimately related to both sides of those health issues, in this review we aim to analyze the peculiarities of inflammation and mortality risk in the Latin-American PD population.

Markers of inflammation before and after renal transplantation.

BACKGROUND: This study aims to compare serum C-reactive protein (CRP), interleukin (IL-6), and tumor necrosis factor (TNF)-alpha in end-stage renal disease (ESRD) patients before versus after receiving renal transplantation (RT) and versus donors. METHODS: Serum samples from 37 ESRD patients (24 male, age 34+/-13 years) were collected before and after RT; in addition, samples from 31 donors were obtained at transplantation. CRP concentrations were measured using nephelometry, and TNF-alpha and IL-6 were measured by enzyme-linked immunoadsorbent assay. RESULTS: Ninety-two percent of recipients had a living donor, 73% received cyclosporine A, 27% tacrolimus, and 70% induction with daclizumab. Thirteen percent had acute rejection and 16% chronic allograft nephropathy. All inflammation markers decreased 6 months after RT, but only CRP was below baseline values (baseline: 5.0+/-3.5; 6 months: 3.0+/-0; 12 months: 3.2+/-0.7; 18 months: 3.2+/-0.6; donors: 3.6+/-1.5 mg/L; P<0.05), whereas median TNF-alpha (baseline: 0.1 [0.03-0.2]; 6 months: 0 [0-0.1]; 12 months: 0.3 [0.1-2.6]; 18 months: 0.6 [0.1-1.9]; donors: 0 [0-0.1] pg/mL; P<0.05) and IL-6 (baseline: 1.9 [1.2-7.1]; 6 months: 1.2 [0.6-28.3]; 12 months: 2.6 [1.3-3.4]; 18 months: 2.7 [1.7-4.2]; donors: 1.1 [0.6-1.9] pg/mL; P<0.05) significantly increased up to the end of follow-up. Before RT, CRP correlated with age (r 0.45, P=0.006) and albumin (r -0.36, P=0.04). TNF-alpha and IL-6 were correlated before (r 0.34, P=0.04) and after (r 0.55, P=0.02) RT. Inflammation markers were not different in patients who had acute rejection episodes or chronic nephropathy. CONCLUSIONS: Compared with controls, patients displayed an inflammatory phenomenon before receiving RT. Serum CRP decreased significantly after RT, whereas TNFalpha and IL-6 increased.

Randomized, open label, controlled clinical trial of oral administration of an egg albumin-based protein supplement to patients on continuous ambulatory peritoneal dialysis.

BACKGROUND/AIM: Malnutrition is highly prevalent in patients on continuous ambulatory peritoneal dialysis (CAPD) and is a strong predictor of increased morbidity and mortality. Therefore, the aim of this study was to evaluate the effect of oral administration of an egg albumin-based protein supplement on the nutritional status of CAPD patients. METHODS: In this randomized, open label, controlled clinical trial, 28 CAPD patients were allocated to a study (n = 13) or a control (n = 15) group. Both groups received conventional nutritional counseling; the study group received, additionally, an oral egg albumin-based supplement. During a 6-month follow-up, all patients had monthly clinical and biochemical evaluations and quarterly assessments of adequacy of dialysis and nutrition. RESULTS: Serum albumin Levels were not different between groups; however, a significant increase (baseline vs final) was observed in the study group (2.64+/-0.35 vs 3.05+/-0.72 g/dL) but not in the control group (2.66+/-0.56 vs 2.80+/-0.54 mg/dL). Calorie and protein intake increased more in the study group (calories 1331+/-432 vs 1872+/-698 kcal; proteins 1.0+/-0.3 vs 1.7+/-0.7 g/kg) than in the control group (calories 1423+/-410 vs 1567+/-381 kcal; proteins 1.0+/-0.4 vs 1.0+/-0.3 g/kg). Similarly, non-protein nitrogen appearance rate (nPNA) increased significantly more in the study (1.00+/-0.23 vs 1.18+/-0.35 g/kg/day) than in the control group (0.91+/-0.11 vs 0.97+/-0.14 g/kg/ day). Triceps skinfold thickness (TSF) and midarm muscle area (MAMA) displayed a nonsignificant trend to a greater increase in the study group (TSF 16.7+/-8.7 vs 18.3+/-10.7 mm; MAMA 23.8+/-6.2 vs 25.8+/-5.9 cm2) than in controls (TSF 16.4+/-5.7 vs 16.9+/-7.0 mm; MAMA 28.7+/-7.8 vs 30.0+/-7.9 cm2). At the end of follow-up, the frequency of patients with moderate or severe malnutrition decreased 6% in the control group and decreased 28% in the study group. At the final evaluation, the most important predictors of serum albumin were the oral egg albumin-based supplement administration and protein intake (p < 0.05); secondary predictors (p = 0.06) were peritoneal transport rate and MAMA. CONCLUSIONS: In the study group, oral administration of the egg albumin-based supplement significantly improved serum albumin, calorie and protein intake, and nPNA, and, compared to controls, this maneuver was associated with a trend to increased anthropometric parameters and improved Subjective Global Assessment evaluation. Oral administration of the albumin supplement and protein intake were the most significant predictors of serum albumin at the end of follow-up. This oral supplement may be a safe, effective, and cheap method to improve nutritional status in peritoneal dialysis patients.