Effect of a personalized nutritional intervention program on nutritional status, quality of life and mortality in hemodialysis patients / Efecto de un programa de intervención nutricional personalizado en el estado nutricional, calidad de vida y mortalidad en pacientes en hemodiálisis

Objective: dietary advice provided through a nutritional intervention program (NIP) is recommended by renal clinic guidelines to prevent or treat malnutrition, that could improve quality of life (QoL) and survival in hemodialysis (HD) patients. This study set out to evaluate the effect of a personalized NIP on the nutritional status and its impact on QoL and mortality in dialyzed patients. Material and methods: this was a 12-month intervention study with regular follow-up in which nutritional parameters were measured at baseline and after 6 and 12 months. QoL was assessed by the Kidney Disease Quality of Life version 1.2 (KDQOL-SF) at baseline and at the end of the study. All dialyzed patients received individualized consultations with a trained dietitian. The content of the nutritional education program included a personalized meal plan and educational materials addressing nutrition to manage fluids, electrolytes, and vitamin D. Results: a total of 75 patients were included. After the NIP, visceral proteins, phosphorous, potassium and vitamin D levels had improved significantly (p < 0.001). The percentage of well-nourished patients increased by 30 % (p < 0.001). At the end of the study, the well-nourished patients had significantly improved scores on the general summary areas of the KDQOL-SF, reduced worry concerning fluid and dietary restrictions (p < 0.001), and the survival rate was 12 months longer (p < 0.01). Conclusion: the results of this study suggest that personalized NIP contributed to improved nutritional status, QoL and survival in HD patients. (AU)

Objetivo: el asesoramiento dietético proporcionado a través de un programa de intervención nutricional (PIN) es recomendado por las guías clínicas renales para prevenir o tratar la desnutrición, puediendo mejorar la calidad de vida (CV) y la supervivencia en pacientes en hemodiálisis (HD). El objetivo de este estudio fue evaluar el efecto de un PNI personalizado sobre el estado nutricional y su impacto en la calidad de vida y la mortalidad en pacientes dializados. Material y métodos: estudio de intervención de 12 meses de duración, con seguimiento periódico de los pacientes en el que se midieron los parámetros nutricionales al inicio, a los 6 y 12 meses. La CV fue evaluada por el cuestionario Kidney Disease Quality of Life versión 1.2 (KDQOL-SF) al inicio y al final del estudio. Todos los pacientes dializados recibieron consultas individualizadas con un dietista. El contenido del programa de educación nutricional incluyó un plan de alimentación personalizado y materiales educativos sobre nutrición para el manejo de fluidos, electrolitos y vitamina D. Resultados: se incluyeron un total de 75 pacientes. Después del PIN, los niveles de proteínas viscerales, fósforo, potasio y vitamina D habían mejorado significativamente (p < 0,001). El porcentaje de pacientes bien nutridos aumentó un 30 % (p < 0,001). Al final del estudio, los pacientes bien nutridos mejoraron significativamente las puntuaciones en las áreas de resumen general del KDQOL-SF, redujeron la preocupación por las restricciones dietéticas y de líquidos (p < 0,001) y la tasa de supervivencia fue de 12 meses superior (p < 0,01). Conclusión: los resultados de este estudio sugieren que el PIN personalizado contribuyó a mejorar el estado nutricional, la calidad de vida y la supervivencia en pacientes en HD. (AU)

Effect of a personalized nutritional intervention program on nutritional status, quality of life and mortality in hemodialysis patients.

Introduction: Objective: dietary advice provided through a nutritional intervention program (NIP) is recommended by renal clinic guidelines to prevent or treat malnutrition, that could improve quality of life (QoL) and survival in hemodialysis (HD) patients. This study set out to evaluate the effect of a personalized NIP on the nutritional status and its impact on QoL and mortality in dialyzed patients. Material and methods: this was a 12-month intervention study with regular follow-up in which nutritional parameters were measured at baseline and after 6 and 12 months. QoL was assessed by the Kidney Disease Quality of Life version 1.2 (KDQOL-SF) at baseline and at the end of the study. All dialyzed patients received individualized consultations with a trained dietitian. The content of the nutritional education program included a personalized meal plan and educational materials addressing nutrition to manage fluids, electrolytes, and vitamin D. Results: a total of 75 patients were included. After the NIP, visceral proteins, phosphorous, potassium and vitamin D levels had improved significantly (p < 0.001). The percentage of well-nourished patients increased by 30 % (p < 0.001). At the end of the study, the well-nourished patients had significantly improved scores on the general summary areas of the KDQOL-SF, reduced worry concerning fluid and dietary restrictions (p < 0.001), and the survival rate was 12 months longer (p < 0.01). Conclusion: the results of this study suggest that personalized NIP contributed to improved nutritional status, QoL and survival in HD patients.

Introducción: Objetivo: el asesoramiento dietético proporcionado a través de un programa de intervención nutricional (PIN) es recomendado por las guías clínicas renales para prevenir o tratar la desnutrición, puediendo mejorar la calidad de vida (CV) y la supervivencia en pacientes en hemodiálisis (HD). El objetivo de este estudio fue evaluar el efecto de un PNI personalizado sobre el estado nutricional y su impacto en la calidad de vida y la mortalidad en pacientes dializados. Material y métodos: estudio de intervención de 12 meses de duración, con seguimiento periódico de los pacientes en el que se midieron los parámetros nutricionales al inicio, a los 6 y 12 meses. La CV fue evaluada por el cuestionario Kidney Disease Quality of Life versión 1.2 (KDQOL-SF) al inicio y al final del estudio. Todos los pacientes dializados recibieron consultas individualizadas con un dietista. El contenido del programa de educación nutricional incluyó un plan de alimentación personalizado y materiales educativos sobre nutrición para el manejo de fluidos, electrolitos y vitamina D. Resultados: se incluyeron un total de 75 pacientes. Después del PIN, los niveles de proteínas viscerales, fósforo, potasio y vitamina D habían mejorado significativamente (p < 0,001). El porcentaje de pacientes bien nutridos aumentó un 30 % (p < 0,001). Al final del estudio, los pacientes bien nutridos mejoraron significativamente las puntuaciones en las áreas de resumen general del KDQOL-SF, redujeron la preocupación por las restricciones dietéticas y de líquidos (p < 0,001) y la tasa de supervivencia fue de 12 meses superior (p < 0,01). Conclusión: los resultados de este estudio sugieren que el PIN personalizado contribuyó a mejorar el estado nutricional, la calidad de vida y la supervivencia en pacientes en HD.

Social environment characteristics are related to self-rated health in four Latin America countries: Evidence from the SALURBAL Project.

We investigated the associations of social and built environment and demographic features of urban areas with self-rated health among adults living in four Latin American countries. We estimated multilevel models with harmonized data from 69,840 adults, nested in 262 sub-cities and 112 cities, obtained from the Salud Urbana en América Latina project. Poor self-rated health was inversely associated with services provision score at the sub-city-level and with social environment index at the city-level. We did not identify associations of built environment and demographic features with self-rated health. Approaches and policies to improve health in Latin American should be urban context-sensitive.

Plasma ionized calcium and magnesium concentrations and prevalence of subclinical hypocalcemia and hypomagnesemia in postpartum grazing Holstein cows from southern Chile.

The objective was to determine the plasma concentrations of ionized Ca (iCa) and Mg (iMg) and to establish the prevalence of subclinical hypocalcemia (SCHC) and hypomagnesemia (SCHM) in dairy cows at calving (within 6 hours of parturition) and at 7 days postpartum (pp) in Chilean grazing herds with spring parturitions. Plasma iCa and iMg were assessed using a clinical analyzer. A total of 113 and 175 cows in 18 herds selected at random were sampled at calving and at 7 days pp, respectively. From these 18 herds, 11 herds provided reliable records of lactation number and 8 cows per herd were scored for body condition and sampled at calving and then at 7 days pp. Ionized Ca concentrations for the 18 herds were 0.99 ± 0.16 mmol/L (calving) and 1.01 ± 0.13 mmol/L [7 d pp (P > 0.05)]. Ionized Mg concentrations were 0.58 ± 0.12 mmol/L and 0.51 ± 0.09 mmol/L (P ≤ 0.05). For the 11 herds, iCa concentrations at calving were 1.06 mmol/L (lactation 1), 1.02 mmol/L (lactation 2) and 0.89 mmol/L (lactation ≥ 3), while iMg concentrations were 0.63 mmol/L, 0.60 mmol/L, and 0.61 mmol/L, respectively. Herd prevalence for SCHC (iCa < 1.0 mmol/L) at calving was 64.8%. Prevalence by parity was 40%, 54.5% and 86.7% for lactations 1, 2 and ≥ 3, respectively. Herd prevalence of SCHC on day 7 pp was 30.1%. For SCHM (iMg < 0.52 mmol/L) prevalence was 21.6% and 48.9% at calving and at 7 days pp, respectively.

ROLE OF AUTOPHAGY IN THE ETIOPATHOGENESIS OF ORAL CANCER. SCOPING REVIEW / ROL DE LA AUTOFAGIA EN LA ETIOPATOGÉNESIS DEL CÁNCER ORAL. REVISIÓN SISTEMÁTICA EXPLORATORIA / PAPEL DA AUTOFAGIA NA ETIOPATOGÊNESE DO CÂNCER ORAL. REVISÃO SISTEMÁTICA EXPLORATÓRIA

In this exploratory systematic review, we present the evidence recorded in the literature, that autophagy can generate both a procancer and anticancer action, acting through various mechanisms in which the autophagy process can be increased, decreased, or altered, through the activation of intracellular signaling pathways. Currently, there is sufficient evidence to support the association between autophagy and different types of cancer, however, there is no review that brings together the various mechanisms by which the autophagic process participates in its development and/or suppression. It was possible to show that there are various mechanisms by which autophagy participates in the development of oral carcinogenesis, influencing both the inhibition and the production of cancer. It is of great importance to increase the knowledge about this process because it could be used as a valuable tool in the treatment of this disease.

En esta revisión sistemática exploratoria, presentamos la evidencia registrada en la literatura, de que la autofagia puede generar una acción tanto procáncer como anticáncer, actuando a través de diversos mecanismos en los cuales el proceso de autofagia puede estar aumentado, disminuido o alterado, mediante la activación de vías de señalización intracelular. En la actualidad, hay evidencia suficiente que avala la asociación entre autofagia y distintos tipos de cáncer, sin embargo, no hay una revisión que reúna los diversos mecanismos por los cuales el proceso autofágico participa en su desarrollo y/o supresión. Se logro evidenciar que existen variados mecanismos por los cuales la autofagia participa en el desarrollo de la carcinogénesis oral, influyendo tanto en la inhibición como en la producción de cáncer. Es de gran importancia aumentar el conocimiento acerca de este proceso, debido a que podría ser utilizado como una herramienta valiosa en el tratamiento de esta enfermedad.

Nesta revisão exploratória sistemática, apresentamos as evidências registradas na literatura, de que a autofagia pode gerar ação tanto procancer quanto anticancerígena, atuando por meio de diversos mecanismos nos quais o processo de autofagia pode ser aumentado, diminuído ou alterado, por meio da ativação de vias de sinalização intracelular . Na atualidade, há evidências suficientes de que há associação entre autofagia e diferentes tipos de câncer, sem embargo, não há uma revisão que reúna os diversos mecanismos por meio dos quais o processo autofágico participa de seu desenvolvimento e/ou supressão. Se logro evidenciar que existem vários mecanismos pelos quais a autofagia participa no desenvolvimento da carcinogênese oral, influenciando tanto na inibição como na produção de câncer. É de grande importância aumentar o conhecimento sobre este processo, devido a que poderia ser usado como um usuário avaliado no tratamento desta doença.

[Alternating Hemiplegia of Childhood associated with a pathogenic variant of the ATP1A3 gene]. / Hemiplejía Alternante de la Infancia asociada a variante patogénica del gen ATP1A3.

INTRODUCTION: Alternating hemiplegia of childhood (AHC), is a rare disease characterized by episodes of hemi/quadriplegia, dystonic postures, abnormal eye movements, and movement disorders. ATP1A3 gene mu tations are the most frequently associated with AHC. OBJECTIVE: To present a clinical case of AHC, where genetic study and the observation of home videos were of great diagnostic utility. CLINICAL CASE: Female patient who at 3 months of age presented with several episodes of dystonic postures, clonic movements of extremities, cephalic version, and lateral gaze deviation lasting several minutes. Epilepsy was diagnosed and levetiracetam was administrated, without improvement. EEG and brain MRI were performed, with normal results. Therefore, epilepsy was ruled out and transient dystonia of infancy was suspected, however, the events became more frequent, longer in duration, and charac teristically subsided during sleep. Family members provided home videos that clarified the events. At 6 months of age, the patient presented with alternating hemiparesis. Dystonia genetic panel showed a pathogenic variant of the ATP1A3 gene, confirming the diagnosis. Flunarizine treatment was ini tiated with a good clinical response at 12 months of follow-up. CONCLUSIONS: The diagnosis of AHC is complex and is frequently confused with epilepsy, so it is important to correctly perform the diffe rential diagnosis, including anamnesis, tests such as EEG, and careful observation of clinical events that, with the current access to audiovisual technology, becomes more accurate. The genetic analysis is a great diagnostic tool that, when performed in time, avoids other unnecessary tests and therapies.

The impact of nutritional status on health-related quality of life in hemodialysis patients.

Malnutrition is frequent in hemodialysis (HD) patients. Nutritional deficiencies may negatively impact quality of life (QOL). This study examines the utility of the Malnutrition-Inflammation Score (MIS) in detecting nutritional risk (NR) and assesses the correlation between nutritional status and QOL in dialysis patients upon starting a nutritional intervention program (NIP). One hundred and twenty patients were included in this cross-sectional study. The MIS was used to detect NR and the Kidney Disease Quality of Life (KDQOL-SF) instrument version 1.2 was used to assess QOL. 62% of patients were found to be at NR (MIS > 5). Nutritional status was significantly correlated with all generic QOL sub-scales. On a multiple linear regression analysis, malnutrition showed the highest level of explanation in the Kidney Disease Summary Component which explained 28.9% of the variance; the Physical Component Summary which explained 33% of the variance; and the Mental Component Summary which explained 21.5% of the variance. Malnutrition was found to be the most significant predictor of impaired scores on the KDQOL-SF. The use of MIS to identify patients at NR and a nutritional assessment to detect malnutrition in its early stages are important given the effects a NIP can have on improving QOL in HD patients.

Measuring Precarious Employment: Type of Contract Can Lead to Serious Misclassification Error.

This study aims to assess the accuracy of temporary employment as indicator or proxy measure of precarious employment. Using sensitivity and specificity analysis, we compared type of contract (temporary versus permanent) with the Chilean version of the multidimensional Employment Precariousness Scale. Temporary employment exhibited very low sensitivity (<30%) (specificity >90%), resulting in roughly 38% of false negative results. Different EPRES-Ch cut-off scores produced similar results. The main implication of these findings is that the public health relevance of precarious employment is being underestimated both in terms of prevalence and of its association with health, making it critical that valid multidimensional measures of precarious employment be implemented.

Impact of Perinatal Death on the Social and Family Context of the Parents.

BACKGROUND: Perinatal death (PD) is a painful experience, with physical, psychological and social consequences in families. Each year, there are 2.7 million perinatal deaths in the world and about 2000 in Spain. The aim of this study was to explore, describe and understand the impact of perinatal death on parents' social and family life. METHODS: A qualitative study based on Gadamer's hermeneutic phenomenology was used. In-depth interviews were conducted with 13 mothers and eight fathers who had suffered a perinatal death. Inductive analysis was used to find themes based on the data. RESULTS: Seven sub-themes emerged, and they were grouped into two main themes: 1) perinatal death affects family dynamics, and 2) the social environment of the parents is severely affected after perinatal death. CONCLUSIONS: PD impacts the family dynamics of the parents and their family, social and work environments. Parents perceive that society trivializes their loss and disallows or delegitimizes their grief. IMPLICATIONS: Social care, health and education providers should pay attention to all family members who have suffered a PD. The recognition of the loss within the social and family environment would help the families to cope with their grief.

RELINF: prospective epidemiological registry of lymphoid neoplasms in Spain. A project from the GELTAMO group.

Lymphomas are a large, heterogeneous group of neoplasms with well-defined characteristics, and this heterogeneity highlights the importance of epidemiological data. Knowledge of local epidemiology is essential to optimise resources, design clinical trials, and identify minority entities. Given there are few published epidemiological data on lymphoma in Spain, the Spanish Lymphoma and Autologous Bone Marrow Transplant Group created the RELINF project. The aim of this project is to determine the frequencies and distribution of lymphoid neoplasms in Spain and to analyse survival. We developed an online platform for the prospective collection of data on newly diagnosed cases of lymphoma in Spain between January 2014 and July 2018; 11,400 patients were registered. Diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL) were the most frequent lymphomas in our series. Marginal B cell lymphoma frequency was higher than that reported in other studies, representing more than 11% of mature B cell lymphomas. Peripheral T cell lymphoma not otherwise specified (PTCL-NOS) was the most common subtype of T cell lymphoma, and NK/T cell lymphomas were more frequent than expected (5.4% of total). Hodgkin's lymphoma accounted for 12% of lymphoproliferative syndromes. Overall survival was greater than 90% at 2 years for indolent B cell lymphomas, and approximately 60% for DLBCL, somewhat lower than that previously reported. Survival was poor for PTCL-NOS and angioimmunoblastic T cell lymphoma, as expected; however, it was somewhat better than that in other studies for anaplastic large cell anaplastic lymphoma kinase lymphomas. This is the first prospective registry to report the frequencies, distribution, and survival of lymphomas in Spain. The frequencies and survival data we report here are globally consistent with that reported in other Western countries. These updated frequencies and survival statistics are necessary for developing appropriate management strategies for neoplasias in the Spanish population.

Parents' Experiences About Support Following Stillbirth and Neonatal Death.

BACKGROUND: Stillbirth and neonatal death are one of the most stressful life events, with negative outcomes for parents. Society does not recognize this type of loss, and parental grieving is particularly complicated and intense. PURPOSE: The aim of this study was to describe and understand the experiences of parents in relation to professional and social support following stillbirth and neonatal death. METHODS: This was a qualitative study based on Gadamer's hermeneutic phenomenology. Twenty-one semistructured interviews were carried out. Inductive analysis was used to find themes based on the data. RESULTS: Twenty-one parents (13 mothers and 8 fathers) from 6 families participated in the study. The analysis identified 2 main themes: (1) "professional care in dealing with parents' grief," with the subthemes "important aspects of professional care," "continuing of pathways of care"; and (2) "effects of social support in parental grief," including the subthemes "the silence that surrounds grieving parents," "family and other children: a key element," and "perinatal loss support groups: a reciprocal help." IMPLICATIONS FOR PRACTICE: Counseling and support according to parents' requirements by an interdisciplinary team of professionals educated in perinatal loss and ethical family-centered care is needed. A social support system for families is necessary to avoid negative emotional consequences. IMPLICATIONS FOR RESEARCH: Further research is needed to analyze midwives' and nurses' experience as facilitators to improve parental grief and the difficulties experienced by the family, other children, and friends of parents with perinatal loss in providing support.

Experience of parents who have suffered a perinatal death in two Spanish hospitals: a qualitative study.

BACKGROUND: Perinatal grief is a process that affects families in biological, psychological, social and spiritual terms. It is estimated that every year there are 2.7 million perinatal deaths worldwide and 4.43 deaths for every 1000 births in Spain. The aim of this study is to describe and understand the experiences and perceptions of parents who have suffered a perinatal death. METHODS: A qualitative study based on Gadamer's hermeneutic phenomenology. The study was conducted in two hospitals in the South of Spain. Thirteen mothers and eight fathers who had suffered a perinatal death in the 5 years prior to the study participated in this study. In-depth interviews were carried out for data collection. Inductive analysis was used to find themes based on the data. RESULTS: Eight sub-themes emerged, and they were grouped into three main themes: 'Perceiving the threat and anticipating the baby's death: "Something is going wrong in my pregnancy"'; 'Emotional outpouring: the shock of losing a baby and the pain of giving birth to a stillborn baby'; "We have had a baby": The need to give an identity to the baby and legitimise grief'. CONCLUSION: The grief suffered after a perinatal death begins with the anticipation of the death, which relates to the mother's medical history, symptoms and premonitions. The confirmation of the death leads to emotional shock, characterised by pain and suffering. The chance to take part in mourning rituals and give the baby the identity of a deceased baby may help in the grieving and bereavement process. Having empathy for the parents and notifying them of the death straightaway can help ease the pain. Midwives can help in the grieving process by facilitating the farewell rituals, accompanying the family, helping in honouring the memory of the baby, and supporting parents in giving the deceased infant an identity that makes them a family member.

Impact of a phone app on nephrology referral.

BACKGROUND: Various factors can lead to inadequate nephrology referral decisions being taken by clinicians, but a major cause is unawareness of guidelines, recommendations and indications, or of appropriate timing. Today, tools such as smartphone applications (Apps) can make this knowledge more accessible to non-nephrologist clinicians. Our study aim is to determine the effectiveness of a purpose-built app in this respect. METHODS: In a retrospective study, nephrology referrals were compared before and after the introduction of the app in clinical practice. The initial study population consisted of first visits by patients referred to our department in 2015, before the introduction of the app. In 2016, the smartphone app NefroConsultor began to be implemented in our hospital. We compared the initial study population with the results obtained for patients referred in 2017, when the app was in use, taking into account clinical features considered, such as urinalysis, proteinuria or kidney ultrasound, to determine whether these patients met currently recommended criteria for referral. RESULTS: The total study population consisted of 628 patients, of whom 333 were examined before the introduction of the app (in 2015) and 295 when it was in use (in 2017). Among the first group, 132 (39.6%) met established KDIGO criteria for nephrology referral and were considered to be correctly referred. Among the second group, 200 (67.8%) met the criteria and were considered to be properly referred (P = 0.001). The increase in the rate of intervention success (before-after app) was 28.8% with a binomial effect size display (Cohen's d effect size) of 0.751. Before the introduction of the app, data for albuminuria were included in 62.5% of nephrology referrals; in 2017, the corresponding value was 87.5% (P = 0.001). In the same line, referrals including urinalysis rose from 68.5% to 85.8% (P = 0.001). Multivariate regression analysis, using referrals meeting KDIGO criteria as the dependent variable and adjusting for age, sex and referring department, showed that the 2017 group (after the introduction of NefroConsultor) was associated with an odds ratio of 3.57 (95% confidence interval 2.52-5.05) for correct referrals, compared with the 2015 group (P = 0.001). References to proteinuria as the reason for nephrology referral also increased from 23.7% to 34.2% (P = 0.004). CONCLUSIONS: Use of the app is associated with more frequent studies of albuminuria at the time of referral and a greater likelihood of proteinuria being cited as the reason for referral. The smartphone app considered can improve the accessibility of information concerning nephrology referrals and related studies.

IHDIP: a controlled randomized trial to assess the security and effectiveness of the incremental hemodialysis in incident patients.

BACKGROUND: Most people who make the transition to renal replacement therapy (RRT) are treated with a fixed dose thrice-weekly hemodialysis réegimen, without considering their residual kidney function (RKF). Recent papers inform us that incremental hemodialysis is associated with preservation of RKF, whenever compared with conventional hemodialysis. The objective of the present controlled randomized trial (RCT) is to determine if start HD with one sessions per week (1-Wk/HD), it is associated with better patient survival and other safety parameters. METHODS/DESIGN: IHDIP is a multicenter RCT experimental open trial. It is randomized in a 1:1 ratio and controlled through usual clinical practice, with a low intervention level and non-commercial. It includes 152 incident patients older than 18 years, with a RRF of ≥4 ml/min/1.73 m2, measured by renal clearance of urea (KrU). The intervention group includes 76 patients who will start with incremental HD (1-Wk/HD). The control group includes 76 patients who will start with thrice-weekly hemodialysis régimen. The primary outcome is assessing the survival rate, while the secondary outcomes are the morbidity rate, the clinical parameters, the quality of life and the efficiency. DISCUSSION: This study will enable to know the number of sessions a patient should receive when starting HD, depending on his RRF. The potentially important clinical and financial implications of incremental hemodialysis warrant this RCT. TRIAL REGISTRATION: U.S. National Institutes of Health, ClinicalTrials.gov . Number: NCT03239808 , completed 13/04/2017. SPONSOR: Foundation for Training and Research of Health Professionals of Extremadura.

Justificación y diseño de DiPPI: un ensayo controlado aleatorizado para evaluar la seguridad y la efectividad de la hemodiálisis progresiva en pacientes incidentes / Rationale and design of DiPPI: A randomized controlled trial to evaluate the safety and effectiveness of progressive hemodialysis in incident patients

INTRODUCCIÓN: La hemodiálisis (HD) progresiva es una modalidad de inicio del tratamiento renal sustitutivo adaptada a las necesidades individuales de cada paciente. Está condicionada fundamentalmente por la función renal residual (FRR). En ella, la frecuencia de sesiones con las que el paciente inicia HD (una o 2 sesiones por semana) es menor que en la HD convencional (3 por semana). Dicha frecuencia aumenta (de una a 2, y de 2 a 3) con el declinar de la FRR. Metodología/diseño: DiPPI es un estudio abierto, multicéntrico, experimental, aleatorizado 1:1 y controlado con procedimiento de práctica clínica habitual, de bajo nivel de intervención y no comercial. Incluye 152 pacientes mayores de 18 años, con enfermedad renal crónica estadio 5, que inician HD como tratamiento renal sustitutivo; y la FRR, medida por aclaramiento renal de urea (KrU) es ≥ 4ml/min/1,73 m2. El estudio se basa en un grupo de intervención con 76 pacientes que iniciarán HD con una sola sesión por semana (modalidad progresiva) y un grupo control con 76 pacientes que comenzarán con 3 sesiones por semana. El objetivo primario es evaluar la supervivencia y los objetivos secundarios son la morbilidad (hospitalizaciones), los parámetros clínicos habituales, la calidad de vida y la eficiencia. DISCUSIÓN: Este estudio permitirá conocer, con la máxima evidencia científica, cuántas sesiones debe recibir un paciente al inicio del tratamiento con HD, dependiendo de su FRR. Registro: Registrado en U.S. National Institutes of Health, ClinicalTrials.gov con número NCT03239808

INTRODUCTION: Progressive haemodialysis (HD) is a starting regime for renal replacement therapy (RRT) adapted to each patient's necessities. It is mainly conditioned by the residual renal function (RRF). The frequency of sessions with which patients start HD (one or two sessions per week), is lower than that for conventional HD (three times per week). Such frequency is increased (from one to two sessions, and from two to three sessions) as the RRF declines. Methodology/DESIGN: IHDIP is a multicentre randomised experimental open trial. It is randomised in a 1:1 ratio and controlled through usual clinical practice, with a low intervention level and non-commercial. It includes 152 patients older than 18 years with chronic renal disease stage 5 and start HD as RRT, with an RRF of ≥ 4 ml/min/1.73 m2, measured by renal clearance of urea (KrU). The intervention group includes 76 patients who will start with one session of HD per week (progressive HD). The control group includes 76 patients who will start with three sessions per week (conventional HD). The primary purpose is assessing the survival rate, while the secondary purposes are the morbidity rate (hospital admissions), the clinical parameters, the quality of life and the efficiency. DISCUSSION: This study will enable us to know, with the highest level of scientific evidence, the number of sessions a patient should receive when starting the HD treatment, depending on his/her RRF. Trial registration: Registered at the U.S. National Institutes of Health, ClinicalTrials.gov under the number NCT03239808

Rationale and design of DiPPI: A randomized controlled trial to evaluate the safety and effectiveness of progressive hemodialysis in incident patients. / Justificación y diseño de DiPPI: un ensayo controlado aleatorizado para evaluar la seguridad y la efectividad de la hemodiálisis progresiva en pacientes incidentes.

INTRODUCTION: Progressive haemodialysis (HD) is a starting regime for renal replacement therapy (RRT) adapted to each patient's necessities. It is mainly conditioned by the residual renal function (RRF). The frequency of sessions with which patients start HD (one or two sessions per week), is lower than that for conventional HD (three times per week). Such frequency is increased (from one to two sessions, and from two to three sessions) as the RRF declines. METHODOLOGY/DESIGN: IHDIP is a multicentre randomised experimental open trial. It is randomised in a 1:1 ratio and controlled through usual clinical practice, with a low intervention level and non-commercial. It includes 152 patients older than 18 years with chronic renal disease stage 5 and start HD as RRT, with an RRF of ≥4ml/min/1.73m2, measured by renal clearance of urea (KrU). The intervention group includes 76 patients who will start with one session of HD per week (progressive HD). The control group includes 76 patients who will start with three sessions per week (conventional HD). The primary purpose is assessing the survival rate, while the secondary purposes are the morbidity rate (hospital admissions), the clinical parameters, the quality of life and the efficiency. DISCUSSION: This study will enable us to know, with the highest level of scientific evidence, the number of sessions a patient should receive when starting the HD treatment, depending on his/her RRF. TRIAL REGISTRATION: Registered at the U.S. National Institutes of Health, ClinicalTrials.gov under the number NCT03239808.