Zona Urbana Río Tijuana, Mexico

Dietary Sodium (DS) Intervention to Reduce Volume Overload and Tissue Sodium in Magnetic Resonance Imaging (MRI) for Hemodialysis (HD) Patients

Recent studies illustrate that tissue sodium is regulated by immune cells in interstitial fluids such as the skin and muscle. Localized immune responses in these tissues can promote vascular endothelial growth factor secretion to promote lymphatic release of fluid and electrolytes, which has significant implications for blood pressure control and cardiovascular health. Furthermore, sodium composition of the diet has the potential to promote beneficial gut bacteria in addition to lowering auto-immune response and blood pressure. The purpose of this pilot study is to utilize this 21Na-MRI coil to quantify changes of sodium levels in the skin and skeletal muscle in hemodialysis treatments before and after a low-sodium diet intervention. In this study, all HD patients will undergo a 30-day observation period (CON) followed by a low-sodium diet period (INT) for 30 additional days. Testing will occur at baseline and after each time-point (three time points total). During the CON period, patients will have no changes to their normal dialysis treatment, and will be asked to follow their normal diet. During the INT period, patients will provided a low- sodium diet intervention that includes receiving 3 low sodium meals per day and snacks provided by momsmeals.com. The study outcomes include: clinical outcomes (hospitalizations, treatment efficiency) changes in tissue sodium, cardiovascular measures (blood pressure, cardiac output, and vascular resistance) and fluid/hydration status (total body water, extracellular fluid) using bioelectrical impedance. We will also collect serum to analyze the relationship between changes in tissue sodium and serum minerals (e.g. sodium and potassium), and other factors believed to help regulate tissue sodium levels, including vascular endothelial growth factor (VEGF), and markers of inflammation (CRP, IL-6). Additionally, we plan to collect patient stool samples to analyze how changes in dietary sodium consumption impact the gut microbiome. This study will demonstrate the feasibility of utilizing 23Na-MRI to quantify skin and muscle sodium levels, as well as provide pilot data regarding the relationship between tissue sodium accumulation, inflammation, the gut microbiome, insulin resistance, and cardiovascular health in hemodialysis patients. Results from this study will then be used to design larger trials to investigate related questions.

Traditional Chinese Medicine (TCM) Colon Dialysis Treats Non-dialysis End-Stage Kidney Disease

Patients who would hospitalized in Nephrology of Guangdong Provincial Hospital of Traditional Chinese Medicine have chance to participate this study. All participates will be divided into two groups depending on their individual treatment interests and the baseline information will be balanced. Integrated Therapy is routine symptomatic and supportive treatment for CRF,including reducing blood pressure and urine protein, improving anemia，regulating calcium and phosphorus metabolism and so on.The colon lotion used in colonic dialysis is a kind of hospital preparation. It consists of Rhubarb, Concha ostreae and some other traditional Chinese medicine.The whole treatment lasts about 10 days,as long as a regular drill-and-fill procedure. Before and after the treatment, related body dimensions will be tested.

Chinese Cohort Study of Chronic Kidney Disease

The study is a multicenter prospective cohort study, aimed to explore underlying mechanisms of chronic kidney disease progression and its association with adverse consequences. The study will establish a baseline cohort of 5000 Chinese pre-dialysis chronic kidney disease patients, who will be followed up until death or dropout or starting renal replacement therapy. The follow-up will be conducted for at least 5 years. Their clinical information and biomaterials will be collected at baseline and then annually during follow-up. The baseline visit includes the following items: detailed demographics; socioeconomic and health care services information; medical and family history; medication history; and questionnaires concerning quality of life, health behaviors, depressive and anxiety symptoms, cognitive function, and physical activity. Anthropometric measures (height, weight, waist circumference, hip circumference, resting blood pressure, heart rate, grip strength, and 15-feet measured walk) will also be collected. The laboratory parameters of chemistry test, intact parathyroid hormone, 24-hour urine electrolytes, protein creatinine ratio, and albumin creatinine ratio should also be collected for each participant and measured in the central laboratory. After the baseline visit, participants will return annually for follow-up visits and evaluation. The evaluating items of follow-up visits are similar to the baseline visit, and sample collection. The principal clinical outcomes of the study can be broadly categorized as renal disease events, cardiovascular events, and death. Renal disease events include the incident end stage renal disease or significant loss of renal function.Cardiovascular events include acute myocardial infarction, unstable angina, hospitalization for congestive heart failure, incident serious cardiac arrhythmia, cerebrovascular events, and peripheral vascular diseases. Death is further clarified as cardiac, cerebrovascular, renal, others, or unknown.

Bispectral-Electroencephalography (EEG) in First Time Hemodialysis

Design: A consecutive, clinical, validation study. Setting: Medical University of Graz (Graz, Austria). Patients: Twenty consecutive patients undergoing first hemodialysis are enrolled at Medical University of Graz, Haemodialysis Unit. Agitated patients or patients who fell asleep during the recording are excluded from the final analysis. During the first dialysis session of approximately 3 h, patients were observed for signs of disequilibrium; headaches, dizziness, nausea, vomiting, if they become obtunded, have visual impairments or cramps. Accordingly patients were divided into 2 groups; the "DDS group" of patients who experienced one of the DDS symptoms of headaches, dizziness, nausea, vomiting, become obtunded, have visual impairments or cramps and patients who do not experience any of the DDS symptoms in the "non-DDS group" An assigned nephrologist will assess the physical and mental status of the patients.

Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)

Hyperphosphataemia is highly prevalent in patients with end-stage kidney disease (ESKD) and associated with increased mortality risk. The Clinical Practice Guidelines suggest lowering elevated phosphate levels towards the normal range (level 2C suggestion). However, trial data demonstrating that treatments that lower serum phosphate will improve patient-centred outcomes are lacking. The primary objective is to test the hypothesis that compared to a liberal serum phosphate concentration target of 2.0 to 2.5 mmol/L, intensive lowering of serum phosphate towards the normal level (≤1.50 mmol/L) with phosphate binders reduces the risk of fatal or non-fatal major cardiovascular events in ESKD patients receiving dialysis. The secondary objectives are to test the hypothesis that intensive lowering of serum phosphate towards the normal level with phosphate binders would improve physical health, fatigue, health-related quality of life, patient satisfaction, and pruritus; and be cost-effective. In this pragmatic, multinational, randomised controlled large simple trial, a total of 3600 adult ESKD patients receiving dialysis will be randomised either to intensive (≤1.50 mmol/L) or liberalized (2.0-2.5 mmol/L) serum phosphate target. The choice and dose of phosphate binders will be at the treating physician's discretion and local practice to achieve and maintain serum phosphate concentration within the required target range according to randomisation. The primary endpoint is the composite endpoint of cardiovascular death, non-fatal major cardiovascular or peripheral arterial events. The secondary outcome measures will be individual components of the primary composite endpoint, all-cause death, and utility-based quality of life EQ5D-5L.

Safety and Efficacy of Two Year of RAAS Alone or in Combination With Spironolactone Therapy

Outcome of Arterio-venous Fistula for Adult Hemodialysis Patients in Assiut Governorate

Timing of Renal Replacement Therapy in the Critically Ill Patients

Background - Optimal timing of renal replacement therapy (RRT) initiation in critically ill patients with acute kidney injury (AKI) is unknown - No consensus guides clinical practice on this issue - Conflicting results from randomized controlled trials - Lack of consistency regarding outcome; should we look at morbidity or mortality? - Wide variability in the timing of RRT initiation in this population - This is an important knowledge gap in the support of critically ill patients with AKI Most previous studies have pointed to benefits of early RRT: 1. The SOAP study (Payen 2008) enrolled> 3100 patients and 278 patients required RRT - in these patients, "early RRT" was defined as RRT initiation within two days of ICU admission while "late RRT" was defined as RRT initiation occurring thereafter. The early RRT group was significantly sicker, including higher SAPS II/SOFA scores, greater need for mechanical ventilation, and lower urine output compared to the late RRT group. Despite this (and without adjustment for these clinical differences at baseline), both ICU and hospital mortality along with ICU length of stay were significantly lower in the early RRT group. 2. A secondary analysis of the FINNAKI (Vaara 2014) studied 239 critically ill patients with acute kidney injury treated with renal replacement therapy. The exposure was timing relative to evidence of developing ≥ 1 "conventional" indications, and three groups were defined. A) "Pre-emptive" - no conventional indication. B) "Classic - urgent" - renal replacement therapy started < 12 hr of indication. C) "Classic - delayed" - renal replacement therapy started ≥ 12 hr after indication. The analysis was stratified by group + propensity-matched analysis of "pre-emptive" to non-renal replacement therapy treated. 90-Day Mortality results were quite striking. Pre-emptive renal replacement therapy vs. Classic renal replacement therapy 30% vs. 49%; OR 2.05; 95%, CI 1.0-4.1 Classic Urgent vs. Classic Delayed 39% vs. 68%; OR 3.85; 95% CI, 1.5-10.2 Pre-emptive vs. no renal replacement therapy (67% matched) 27% vs. 49% (diff 22.4%; 95% CI, 7.5-35.9) 3. Karvellas (2011) performed a meta-analysis comparing early vs late initiation of renal replacement therapy. 15 unique studies (2 randomised, 4 prospective cohort, 9 retrospective cohort) out of 1,494 citations. The overall methodological quality was low. Early, compared with late therapy, was associated with a significant improvement in 28-day mortality (odds ratio (OR) 0.45; 95% confidence interval (CI), 0.28 to 0.72). 4. Leite (2013) performed a study of 150 patients with AKIN stage 3. Mortality was lower in the early renal replacement therapy group (51.5 vs. 77.9%, P = 0.001). After achieving balance between the groups using a propensity score, there was a significant 30.5 (95% confidence interval [CI] 14.4 to 45.2%, P = 0.002) relative decrease of mortality in the early renal replacement therapy group. Moreover, patients on the early renal replacement therapy group had lower duration of mechanical ventilation, time on renal replacement therapy and a trend to lower intensive care unit (ICU) length of stay. 5. Shiao (2012) looked at 648 postoperative renal replacement therapy cases. Definitions were: early (EG, ≦1 day), intermediate (IG, 2-3 days), and late (LG, ≧4 days) groups. The in-hospital mortality rate censored at 180 day was defined as the endpoint. A U-shaped curve was found, indicating that intermediate start of renal replacement therapy was beneficial in this cohort. 6. The two RCTs; the AKIKI and ELAIN-studies (2016) from NEJM and JAMA report conflicting results. AKIKI showed no benefit with early initiation of renal replacement therapy but ELAIN did. Complicating matters were the fact that AKIKI dosing was unknown, and IHD was used in around 50% of those patients. There are ongoing randomized controlled trials, but STARRT-AKI (see #2) have released feasibility data. 1. I.D.E.A.L.-I.C.U. (NCT01682590) (start Mar 2012): - RCT of "early" (within 12 hrs of RIFLE-F) vs. "deferred" (48-60 hr) on 90-day mortality in septic AKI (planned recruitment ~ 824) - PI: J.P. Quenot (Dijon) - completion March 2015. 2. STARRT-AKI (NCT01557361) (May 2012-October 2013). "Accelerated" (n=48) vs "Standard" (n=52). 90-day mortality was similar, 38 and 37%. Surviving patients requiring renal replacement therapy at Day 90 were only found in the standard arm, where 3.8% were dialysis dependent. Median ICU length of stay and number of renal replacement therapy sessions were insignificantly lower in the accelerated group. It is clear that more knowledge regarding outcome concerning mortality, morbidity (end-stage renal disease) as well as ICU- and hospital care consumption would be beneficial. The investigators have highly detailed data from three hospitals based on a cohort of over 50 000 ICU patients from Stockholm. The investigators believe that the sheer number of patients combined with the subjective nature* of renal replacement therapy initiation allow for useful information, potentially adding to the knowledge that the RCTs hopefully will bring. *Initiation of renal replacement therapy (= CRRT) is based on a spectrum of clinical information and provider bias. Clinicians always initiate renal replacement therapy when confronted with life-threatening complications (like hyperkalemia or pulmonary edema). However, wide variations in the minimum severity of indications prompting renal replacement therapy initiation exist. Factors influencing decisions include: age, comorbidity, responsiveness to diuretic challenge; illness severity (predicted mortality); prescribing service and time of day. The fact that renal replacement therapy is so "unregulated" is beneficial for a cohort study, as it is likely to create a wide variety of patients in early and late groups. It creates a "natural experiment". If it is good for the patients is another matter. Hypothesis: early renal replacement therapy is beneficial compared to late renal replacement therapy. Methods: this is an observational cohort study of critically ill patients treated in three hospitals (Karolinska Solna, Karolinska Huddinge and Södersjukhuset) and in five different ICUs in Stockholm, Sweden, between 2007 and 2017 using the Clinisoft database. Registry: The Clinisoft database (Centricity Clinisoft, General Electric) is based on a patient database management system (PDMS), implemented 2005 and initially only recorded data from Karolinska University Hospital Solna (Central medicosurgical ICU and neurosurgical/neurological ICU, NIVA) and Karolinska University Hospital Huddinge (medicosurgical ICU, IVA). From 2006 to 2008 the other ICUs (Cardiothoracic ICU, Karolinska Solna and Södersjukhusets two ICUs, one medical and one surgical) started using Clinisoft. Essentially, the investigators will have complete data coverage from 2007/2008-2017. The neurosurgical/neurological ICU will not participate in this study; their patients with need of CRRT are treated in other ICUs. The investigators will collect demographic data, age, sex and comorbidities. Moreover, The investigators will collect ICU specific data; illness severity, mechanical ventilation, need for vasoactive therapy, reason for ICU admission, data on initiation of renal replacement therapy. Post-ICU mortality and mortality data at different time points (30, 60, 90, 180, 365 and when applicable 2 and 3 year mortality) will be reported. Lastly, The investigators will investigate post-ICU morbidity, including new onset CKD diagnosis and ESRD for 90 day survivors. Early renal replacement therapy can be defined in many ways, based on: 1. Blood urea nitrogen level 2. Grade of RIFLE/AKIN/KDIGO stage 3. Hours from ICU admission 4. Degree of fluid overload 5. Level of pH at initiation The Clinisoft registry, as mentioned, based on the Centricity Critical Care suite of programs is run by General Electric. This registry has data based on intensive care monitors and machines, ranging from medical pumps, respirators to invasive monitoring data. The registry also has laboratory variables automatically imported from the electronic medical records (EMR) system, Take Care. Moreover, illness severity scores, central lines, body weight, urinary output and medications are entered manually into the system on a regular basis. Data is regularly audited as part of the hospital standard operating procedure. There are data sum checks ensuring that predefined rules and ranges are followed. The investigators have source data verification, as some laboratory data from the electronic medical records (EMR) system Take Care is exported to the Clinisoft registry. Coding information and a data dictionary exists. Matching: The Standard Operating Procedures for patient recruitment, data collection, data management and data analysis is as follows. For each case of early CRRT, The investigators will create a sequentially propensity matched control patient that a) either will never receive CRRT or b) will go on to get late CRRT based on absolute indications. Absolute indications: 1. hyperkalemia (serum potassium≥6 mEq/L), 2. severe acidosis (pH≤7.15), 3. plasma urea>36 mmol/L (equals BUN=100.8 mg/dl), 4. oliguria or anuria (urine output<0.3 ml/kg per hour for ≥24 hours or anuria for ≥12 hours), and 5. fluid overload with pulmonary edema as defined by the presence of all the following factors: (a) >10% fluid accumulation (cumulative fluid balance/baseline weight>10%), (b) oliguria (urine output<0.5 ml/kg per hour for ≥12 hours), and (c) severely impaired oxygenation (PaO2/FiO2<200 indicated by respiratory Sequential Organ Failure Assessment [SOFA] score≥3) A patient where initiation of renal replacement therapy is started without the absolute indications ("early renal replacement therapy") will be matched based on age, sex, chronic kidney disease, admission diagnosis group, presence of severe sepsis and cumulative urine output. The investigators will try to find matched pairs going on to get "late renal replacement therapy" and never renal replacement therapy; i.e. two matched patients per early renal replacement therapy-patient. Sample size assessment: first off, out of the total number of patients - around 50 000 patients collected during the years 2007-2017 - the investigators anticipate at least 5% treated with CRRT, i.e. 2500 patients. value for p1: 0.35 value for p2: 0.45 value for α: .05 value for power (default is .80): .80 sample size (for each sample separately) is: 376 This power analysis is based on regular alpha and power (0.5 and 0.8) and expects a 10% (a 35% mortality and 45% for early vs late renal replacement therapy) difference in mortality at six months - significantly smaller difference than in the Vaara, Karvellas and Leite studies. This gives us a sample size of 375 patients in the two groups, 750 patients in total. The investigators are likely to greatly exceed the numbers needed to find a difference in mortality if such a mortality difference exists. It is unclear if the investigators will exceed the numbers needed to find a difference in ESRD-morbidity, since the field lacks adequate data to allow for a power analysis. Plan for missing data: our trial design seeks to limit the likelihood of missing data. If variables are missing, unavailable, non-reported or uninterpretable the investigators will use imputation by last observation. This is, admittedly, based on unscientific assumptions, therefore sensitivity analyses will be conducted to assess the robustness of findings when missing data has been an issue. Statistical analysis plan: The investigators will report continuous data as medians with interquartile ranges and categorical data as counts and percentages. The investigators will use the Mann-Whitney U test to compare continuous data and the Fisher's exact test to compare categorical data. All statistics is two-tailed and a P value of less than 0.05 will be considered significant. CRRT initiation will be categorised according to early and late start according to several different criteria i.e. time from ICU admission, biochemical data at initiation and percentage of body weight increase. The investigators will then perform separate univariate and multivariate analysis for each definition, using Cox and Poisson regression models for primary and secondary outcomes and adjust for clinically relevant confounders and independent factors with observed differences between patients with early and late renal replacement therapy initiation. A competing risks polynomial logistic regression will be performed to identify predictors of primary and secondary outcome at 6 months. This risks model will include four-level polytomous outcomes defined as death, ESRD, ESRD and death or no negative outcome. The area under the receiver operating characteristic curve (AUC) will be used to assess discrimination of each of our CRRT timing models. Analysis will be performed using Stata version 12 (StataCorp LP, College Station, Tx, USA).

Glucose Disorders Induced by Tacrolimus on Pre Transplantation Endstage Renal Disease Patients

ACCESS HD: Comparing Catheters to Fistulas in Elderly Patients Starting Hemodialysis

Purpose: This vanguard phase of the RCT will help to address challenges related to patient recruitment, protocol adherence, safety, and data collection in the hemodialysis population. The primary outcome for this vanguard phase of the RCT is feasibility, which will be measured by patient recruitment and protocol adherence. The secondary outcomes include feasibility-related outcomes, safety (which will include expected procedure-related outcomes and causes for hospital admissions), and other protocol violations. Hypothesis: Results obtained from the vanguard phase of the RCT will provide feasibility and safety data for conducting a large RCT, which will establish a better understanding of the clinical outcomes associated with the use of fistula versus catheter for vascular access in the hemodialysis population. Research Method: This is a multicenter, open-label, RCT, and is expected to be conducted over 24 months. All consented and enrolled participants who meet the eligibility criteria will have the following data collected in a minimal dataset: eligibility, age, sex, program/center, height, weight, comorbid conditions, and details of any prior treatment for acute or chronic kidney failure (e.g., previous peritoneal dialysis, kidney transplant, or hemodialysis). The following additional data will be collected at baseline: baseline laboratory values, baseline hemodialysis initiation, history of access procedures, and patient-reported outcome measures (includes data on quality of life and a vascular access questionnaire). The vanguard phase of the RCT will consist of 6 months of site preparation, approximately 24 months of participant accrual, and 6 months of additional follow-up time for the last randomized participant. An additional 6 months will be used to assess the preliminary data, prepare the report of this vanguard phase of the RCT, and to prepare and submit funding applications for the large RCT. Participants in the vanguard phase of the RCT will be rolled into the large RCT, and will therefore be followed for a total of 24 months (2 years) in Canada and a total of 36 months (3 years) in Australia after randomization to assess adherence to the trial protocol, assess safety outcomes, and collect qualitative data. Statistical Analysis Plan: The primary analysis of the vanguard phase of the RCT will be descriptive. The proportion of people meeting each of the feasibility endpoints with accompanying 95% confidence intervals will be calculated. Investigators will describe participant characteristics and evaluate reasons for protocol violation, as well as calculate rates of drop-ins and other events. Interim or subgroup analyses will not be conducted in this vanguard phase of the RCT. Expected Procedure-Related Outcomes (Safety Data): As both catheter and fistula treatment strategies are standard of care, the procedure-related outcomes are well known. Investigators will collect only expected procedure-related outcomes (i.e., events that have a potentially causal relationship to the strategy) that occur within 7 days of the execution of any access related intervention. These will include hospital admissions and prolongation of hospitalization, status changes, bacterial infections, catheter or exit site infections, cannulation injury events. In addition, sites will report all incidents of participant death that occur during the trial period. Cause of death will be determined by trial site investigators, based on a trial-specific list of classifications, and will be adjudicated for accuracy by appropriate members of the trial steering committee, who will be blinded to treatment arm.