Predialysis Serum Albumin Levels Research Articles

Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 Dialyzer: A Randomized Controlled Trial.

Expanded hemodialysis therapy enabled by medium cut-off membranes may promote greater clearance of larger middle molecules that comprise putative uremic solutes than conventional high-flux dialysis. This randomized trial evaluated the efficacy and safety of hemodialysis treatment with a medium cut-off dialyzer. Clinically stable patients on maintenance hemodialysis were randomized to receive dialysis with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (Elisio-17H) over 24 weeks of treatment. The primary safety end point was the predialysis serum albumin level after 24 weeks of treatment. The primary efficacy end point was the reduction ratio of free λ light chains at 24 weeks of treatment. Among 172 patients on maintenance hemodialysis, mean age was 59±13 years, 61% were men, 40% were Black, and mean dialysis vintage was 5±4 years. Of the 86 patients randomized to each dialyzer, 65 completed the trial in each group. The reduction ratio for the removal of free λ light chains was significantly higher in the Theranova 400 group compared with the Elisio-17H group after 4 weeks (39% versus 20%) and 24 weeks (33% versus 17%; both P<0.001). Among secondary end points, the Theranova 400 group demonstrated significantly larger reduction ratios at 4 and 24 weeks for complement factor D, free κ light chains, TNFα, and β2-microglobulin (P<0.001 for all), but not for IL-6. Predialysis serum albumin levels were similar between groups after 24 weeks (4 g/dl with the Theranova 400 and 4.1 g/dl with the Elisio-17H), consistent with noninferiority of the Theranova 400 dialyzer in maintaining predialysis serum albumin levels after 24 weeks of treatment. Hemodialysis therapy with the Theranova 400 dialyzer provides superior removal of larger middle molecules, as exemplified by free λ light chains, compared with a similar size high-flux dialyzer, while maintaining serum albumin level. A Multi-Center, Prospective, Randomized, Controlled, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer in End Stage Renal Disease (ESRD) Patients, NCT03257410.

P1072COMPARISON OF UREMIC TOXINS, INFLAMMATORY MARKERS AND VEGF LEVEL WITH MEDIUM CUT-OFF MEMBRANES AND HIGH-FLUX MEMBRANES IN HEMODIALYSIS: THERANOVA IN SISLI HAMIDIYE ETFAL (THE SHE) STUDY

Abstract Background and Aims Mortality in hemodialysis have not changed since last 30 years which may be caused by inflammation and accumulation of middle and large uremic toxins. Medium cut-off (MCO) membranes are able to perform hemodialysis as effective as hemodiafiltration. Their effect on inflammatory molecules and vascular endothelial growth factor-C (VEGF), an independent factor effective on mortality, are not well known. The aim of the study was to compare intra and inter dialyzer performances of MCO and high-flux dialyzers regarding middle and large uremic toxin, inflammatory marker, VEGF and serum albumin level. Method This is a randomized, prospective, open-label, cross-over study (ClinicalTrials.gov: NCT03836508) approved by local ethic committee. Patients had hemodialysis with either 36 sessions of high-flux dialyzer followed by 36 sessions of medium cut-off dialyzer or vice versa. Pre and postdialysis levels for urea, creatinine, albumin, total protein, free kappa light chain, free lambda light chain, beta-2 microglobulin, myoglobulin levels were determined at first and last sessions of every dialyzer. Postdialysis level of middle and large uremic molecules have been determined by a formula to prevent hemoconcentration effect. Reduction rate for uremic toxins were calculated. Serum level of human VEGF, fibroblast growth factor-23 (FGF-23), interferon gamma (IFN-g), interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-17A (IL-17A) levels were determined at first and last session of the each dialyzer. Results Fifty-two patients were enrolled to the study. Median age of patients was 56.40 (43.87-67.39) years. Median dialysis vintage was 4.77 (3.08-10.09) years. Reduction rates and postdialysis levels of free kappa and lambda light chain, myoglobulin, beta-2 microglobulin were lower both at first and last sessions in medium cut-off dialyzers compared to high-flux dialyzers (p&amp;lt;0.05 for all) (Table 1). Last session predialysis free kappa, free lambda, beta-2 microglobulin level was lower than first session predialysis levels in medium cut-off dialyzers (p&amp;lt;0.05 for all) (Table 2). Last session IL-6, IL-10, IL-17, IFN-gamma levels did not differ between dialyzers (p&amp;gt;0.05 for all). Vascular endothelial growth factor levels were 500.91 (363.80-679.15) pg/ml in medium cut-off group and 610.60 (450.63-1021.93) pg/ml in high-flux group (p=0,043). Predialysis serum albumin level at first session for MCO and high-flux groups were 3.88 (3.71-4.04) g/L and 3.75 (3.59-3.95) g/L, respectively (p=0.086) (Figure 1). After 3 months of hemodialysis, it was 3.62 (3.45-3.88) g/L in MCO group and 3.78 (3.58-4.02) g/L in high-flux group (p=0.04). Serum albumin level has decreased from 3.88 (3.71-4.04) g/L to 3.62 (3.45-3.88) g/L in 3 months during hemodialysis with MCO dialyzers (p=0.0001). It did not change significantly in high-flux group in the same time period (p=0.861). Conclusion MCO membranes not only decrease post dialysis levels of free kappa, free lambda, beta-2 microglobulin, myoglobulin but also decrease the third month predialysis levels of free kappa, free lambda, beta-2 microglobulin. They do not let the increase in myoglobulin level as seen in high-flux dialyzers. Even though the IL-6, IL-10, IL-17, IFN-gamma, FGF-23 levels did not differ, VEGF levels were lower in MCO dialyzer. The most important side effect of hemodialysis with MCO membranes is decreased serum albumin level.

Hemodialysis Session Duration, Ultrafiltration Rate, Interdialytic Weight Gain and their Association with Albumin in Patients on Intermittent Hemodialysis in a Regional Dialysis Unit: A Cross-sectional Study.

AimSeveral studies suggest that a low pre-dialysis serum albumin level (<40g/L) is associated with increased mortality in dialysis patients. The objective of this study was to assess if hemodialysis session duration (HSD), ultrafiltration rate (UFR) and interdialytic weight gain percentage (IDWG%) are associated with pre-dialysis serum albumin levels (markers of all-cause mortality), thus influencing mortality. Method This is a cross-sectional analytical study in which data were collected from a regional cohort of 59 prevalent chronic hemodialysis patients using a national electronic database (eMED). Continuous data were analyzed using a regression model to assess for an association between HSD, IDWG% and UFR with albumin levels.ResultsFifty-six patients were included in the study. Multiple linear regression models demonstrated a cross-sectional association between longer HSD and higher serum albumin levels and a statistically significant positive correlation (r = 0.353; p < 0.05). No significant association of UFR (p = 0.169) and IDWG% (p = 0.549) with albumin was observed. Mean albumin was 38.07 ± 3.96 g/L in the HSD <240 min group compared to 40.50 ± 2.83g/L in the HSD ≥240 min group which was statistically significant (p < 0.05).ConclusionLonger HSD has a cross-sectional association with higher pre-dialysis serum albumin with patients having HSD ≥240 min demonstrating the highest levels of serum albumin. Our study suggests longer HSD may improve mortality in the dialysis population.

MALNUTRITION SCREENING IN AN IN-CENTRE HAEMODIALYSIS UNIT: APPETITE FOR CHANGE?

Best Practice Guidelines recommend regular nutrition assessment of patients receiving haemodialysis, with priority to those with poorly controlled co-morbidities or malnutrition. On a nurse-led monthly care plan, serum albumin is currently being used to identify patients requiring referral to a dietitian. It is well documented that the specificity of serum albumin as a nutritional marker is limited by the presence of inflammation. The purpose was to compare albumin with an alternative screening tool. An annual malnutrition audit was conducted with 100 patients attending in-centre Haemodialysis across two centres. Each were assessed using the PG-SGA or SGA, and asked to rate their appetite on a five point scale (very poor, poor, fair, good or very good). Pre dialysis serum albumin levels were noted. Of the 100 patients assessed, 28% were classified as malnourished. 61% of all patients had a serum albumin of 35 g/L or less. 31% of all patients rated their appetite as being fair, poor or very poor. The sensitivity, specificity, positive predictive values and negative predictive values of albumin and appetite as a screening tool for malnutrition can be seen in the table. Albumin (≤35 g/L) Appetite (≤fair) Sensitivity 0.86 0.78 Specificity 0.49 0.86 Positive Predictive Value 0.39 0.68 Negative Predictive Value 0.90 0.91 If albumin is used as a screen for malnutrition and referral to a dietitian, 61% of those referrals will be assessed by the dietitian as well nourished, and 14% of malnourished patients would be missed. If appetite was used as a screen for malnutrition, 32% of those referrals will be assessed by the dietitian as well nourished, and 22% of malnourished patients would be missed. Asking patients to rate their appetite on a five point scale appears to be an effective way to screen for malnutrition in the haemodialysis population. In centres with limited dietitian support, this may be preferable to screening with albumin due to the reduced number of inappropriate referrals and therefore enabling the priority to lie with the patients with malnutrition.

Clinical outcomes of systemic lupus erythematosus patients undergoing continuous ambulatory peritoneal dialysis

The purpose of this study was to evaluate the outcome of systemic lupus erythematosus (SLE) patients on continuous ambulatory peritoneal dialysis (CAPD). Eighteen SLE patients who had been undergoing CAPD for at least 3 months in our unit were compared with 36 other age- and gender-matched non-diabetic CAPD patients with an underlying primary chronic glomerulonephritis (CGn). The clinical outcome, infective complications, lupus activities, biochemical parameters, haemoglobin level and the use of erythropoietin were reviewed. The duration of dialysis of the two studied groups was not different, with a mean of 35.4 months for the SLE group and 36.7 months for the CGn group. Before dialysis, SLE patients had a significantly lower albumin level (30.4+/-6.6 vs 35.4+/-5.59 g/dl, P<0.01), while the mean haemoglobin levels of the two groups were similar (8.5+/-1.8 g/dl for SLE vs 9.0+/-1.9 g/dl for the control group). However, the weekly dose of erythropoietin (EPO) used was significantly higher in the SLE group (6000 vs 3818 U/week, P<0.01) to maintain a similar haemoglobin level during dialysis. Regarding the infective complications, the SLE group had a higher peritonitis rate (5.7 episodes/100 patient-months vs 2.4 episodes/100 patient-months, P<0.05), and an increase in the non catheter related infection rate (6.67 episodes/100 patient-months vs 1.1 episodes/100 patient-months, P<0.001). However, no significant difference could be demonstrated in the Tenckhoff catheter exit site infection rate (2 episodes/100 vs 1.7 episode/100 patient-months). The number of patients who received a kidney transplant or required a change of mode to haemodialysis was similar among the two groups. Seven patients died during the follow-up period, and the overall mortality rate was much higher in the SLE group than in the control group (0.83/100 vs 0.15/100 patient-months, P<0.05). SLE patients on CAPD have a significantly lower pre-dialysis serum albumin level and use a higher dose of Epo to achieve a comparable haemoglobin level than other non-diabetic CGn CAPD patients. They also have a poorer prognosis in terms of infective complications and mortality rate.

The relationship between serum albumin and hydration status in hemodialysis patients

Objective: A decreased serum albumin level predicts poor survival in end-stage renal failure. Hypoalbuminemia is multifactorial and related to poor nutrition, inflammation, and comorbid disease. Overhydration is also common in renal replacement therapy patients, and hemodilution may also contribute to a low serum albumin level. Design: Crosssectional observational study. Setting: Outpatient hemodialysis unit of a district general hospital. Subjects: We investigated the relationship of serum albumin to C-reactive protein (CRP) and hydration state in 49 unselected hemodialysis patients (28 men). Methods: Patients were assessed predialysis and postdialysis at their clinical dry weight. Extracellular fluid volume (Vecf) and total body water (Vtbw) were estimated by whole-body bioelectric impedance. Vecf was expressed as a percentage of Vtbw (Vecf%Vtbw). Predialysis CRP, predialysis and postdialysis serum albumin, and body weight were measured. Normalized protein catabolic rate (nPCR) and KT/V urea were calculated. Results: Predialysis and postdialysis serum albumin levels were 36.9 g/L (95% CI, 35.7 and 38.1) and 41.4 g/L (95% CI, 39.7 and 43.3), respectively (P <.0001). Mean weight change was 2.0 ± 1.2 kg. Predialysis and postdialysis serum albumin levels were negatively correlated with CRP (before: r = −0.393, P <.005; after: r = −0.445, P =.001) and positively with nPCR (before: r = 0.336, P =.018; after: r = 0.353, P =.013). Predialysis serum albumin level correlated with predialysis Vecf%Vtbw (r = −0.384, P =.006) and postdialysis serum albumin level with postdialysis Vecf%Vtbw (r = −0.654, P <.0001). In multivariate analysis, predialysis albumin was dependent on nPCR (P =.04), CRP (P <.0001), and predialysis Vecf%Vtbw (P =.002), and postdialysis albumin was dependent on nPCR (P =.01), CRP (P =.002), and postdialysis Vecf%Vtbw (both P <.0001). The increase in albumin was strongly correlated with both change in actual weight (r = −0.651, P <.0001) and change in Vecf%Vtbw (r = −0.684, P <.0001). Conclusion: In unselected hemodialysis patients, serum albumin level is dependent on nPCR, CRP, and extracellular fluid volume. This relationship persists after dialysis, suggesting that many patients remain fluid overloaded at their postdialysis dry weight. © 2002 by the National Kidney Foundation, Inc.

Hemodialysis Immediately after Acute Myocardial Infarction

Acute myocardial infarction (AMI) is common in patients who have end-stage renal disease. However, the prudent interval after AMI until resuming hemodialysis is unknown. Also incidence and severity of intradialytic morbid events during the initial dialysis treatment after AMI have not been determined. We conducted a retrospective analysis of the course of hemodialyses performed immediately after AMI in 13 maintenance hemodialysis patients (group 1) hospitalized with AMI over the 5-year period 1988-1992. For comparison, the incidence of intradialytic morbid events (hypotension--systolic blood pressure < 90 or diastolic blood pressure < 60 mm Hg or a fall in systolic or diastolic blood pressure of > 30 mm Hg--with and without symptoms, arrhythmias, and unplanned termination of hemodialysis was extracted from the charts of 9 maintenance hemodialysis patients (group 2) admitted during the same period with angina but no AMI, and in 13 stable ambulatory hemodialysis patients (group 3) dialyzed during the same period who had no evidence of heart disease. Patients in groups 1 and 2 were sorted by time interval from onset of chest pain to initiation of hemodialysis (< 12, 12-24, and > 24 h). In group 1, we examined the relationship of anatomic location of AMI, number of antihypertensive medications, predialysis left ventricular systolic ejection fraction, and various other clinical and laboratory parameters to the incidence intradialytic morbid events. The mean (+/- SD) age of the study subjects was 67 +/- 7.5 years in group 1, 57 +/- 3.7 in group 2, and 60 +/- 11 years in group 3 (p = 0.6). Arrhythmias and early termination of dialysis did not occur in any patient. Intradialytic hypotension (IDH) was recorded in 5 (38%) of 13 patients in group 1, in 3 (33%) of 9 in group 2, and in 2 (15%) of 13 patients in group 3 (p = 0.47). 4 (80%) of 5 patients in group 1 had multiple episodes of IDH. There were 0.92 +/- 1.4 episodes of IDH per patient in group 1 as compared with a rate of 0.44 +/- 0.68 per patient in group 2, and of 0.15 +/- 0.36 per patient in group 3 (p = 0.2). IDH responded to 0.9% normal saline replacement in all cases. Group 1 patients who had IDH (n = 5) were older (68 +/- 3 vs. 58 +/- 7 years, p = 0.01), had a lower diastolic blood pressure at the start of hemodialysis (59 +/- 13 vs. 83 +/- 13 mm Hg; p = 0.01), had a lower post-AMI left ventricular systolic ejection fraction (42 +/- 19 vs. 62 +/- 10%; p = 0.04), and also had a lower predialysis serum albumin level (3.6 +/- 0.4 vs. 4.1 +/- 0.4 g/dl; p = 0.09) than those who did not have IDH (n = 8). All 5 group 1 patients who had IDH (100%) had had prior AMI as compared with 2 (25%) of 8 of those who did not have IDH (p = 0.02). AMI involved the inferior myocardial wall in more (4 of 5; 80%) of the group 1 patients who had IDH as compared with those who did not have IDH (2 of 8; 25%; odds ratio = 9.5; p = 0.08; 95% confidence interval = 0.7-341.0). In group 1 patients, the time from onset of chest pain to hemodialysis did not affect the risk of IDH (p = 0.4). We conclude that a low diastolic blood pressure at onset of hemodialysis prior myocardial infarction, inferior myocardial wall involvement, advanced age, and a low predialysis serum albumin level are risk factors for the development of hypotension during the first hemodialysis session after AMI.