Protocol for thiamine and folic acid in the treatment of cognitive impairment in maintenance haemodialysis patients: a prospective, randomised, placebo-controlled, double-blind, multicentre study

IntroductionCognitive impairment (CI) is the common complications in maintenance haemodialysis (MHD) patients. Recently, the pathogenesis of CI has been discussed and oxidative stress is one of the main mechanisms in these patients. Thiamine and folic acid, which play an important role in relieving the production of reactive oxygen species, reducing homocysteine levels, improving oxidative stress in the nervous system. In pilot study, cognitive function was significantly improved in the group with thiamine and folic supplementation. Based on this result, we hypothesise that thiamine combined with folic acid supplementation may improve cognitive function in patients with MHD.Methods and analysisIn this prospective, randomised, placebo-controlled, double-blind, multicentre study, we will enrol patients undergoing haemodialysis who has the Montreal Cognitive Assessment score lower than 26 to treatment group (thiamine 90 mg/day combined with folic acid 30 mg/day) or control group (thiamine placebo 90 mg/day combined with folic acid placebo 30 mg/day). All subjects will be followed up for 96 weeks. The primary endpoint is the comparison of Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) score between treatment group and control group at 96 weeks of follow-up. The secondary endpoints include serum thiamine, folate, homocysteine levels, cranial functional MRI and survival. The central randomisation method will be adopted and the principles of placebo-controlled, double-blind randomised control will be followed. The comparisons among ADAS-Cog scores and other secondary endpoints over time within subjects is conducted by using repeated measure analysis of variance (ANOVA) or generalised estimating equations (GEE). Pairwise t-test with Bonferroni adjustment is performed for multiple comparisons. On the other hand, for comparisons between treatment and control group, simple one-way ANOVA, GEE or Wilcoxon rank sum test is used. The χ2 method is used for statistical analysis of the categorical data. Kaplan-Meier survival curve is used for survival analysis. A p<0.05 is considered statistically significant difference.Ethics and disseminationThis trial has been approved by Shanghai Jiao Tong University School of Medicine, Renji Hospital Ethics Committee (KY2019-199). After publication of study results, trial report will be published in peer-reviewed journals and/or in national or international conferences.Trial registration numberChiCTR2000029297.

Prevalence and Factors Associated with Sarcopenia in Patients on Maintenance Dialysis in Australia—A Single Centre, Cross-Sectional Study

Background: Sarcopenia is associated with significant morbidity and mortality in patients with chronic kidney disease. The prevalence of sarcopenia in the dialysis population varies from 4% to 63%. However, the prevalence and risk factors of sarcopenia in the Australian dialysis population remain uncertain. Aim: To study the prevalence of sarcopenia in patients on maintenance dialysis by using the European Working Group on Sarcopenia in Older People (EWGSOP) diagnostic criteria of sarcopenia and to identify associated risk factors. Methods: We evaluated adult patients on maintenance haemodialysis and peritoneal dialysis in this single-centre cross-sectional study in Australia. Patient’s clinical (age, gender, dialysis modality and diabetic status) and laboratory parameters (serum albumin, calcium, phosphate, 25-hydroxy-vitamin D and parathyroid hormone levels) were investigated. We employed bioimpedance spectroscopy, hand grip dynamometer and the timed up and go test (TUG) to evaluate muscle mass, strength and function, respectively. Results: We evaluated 39 dialysis patients with a median age of 69 years old. The prevalence of sarcopenia was 18%. Sarcopenia was associated with low serum albumin (p = 0.02) and low serum phosphate level (p = 0.04). Increasing age and female sex were potential risk factors for sarcopenia (p = 0.05 and 0.08, respectively). Low lean muscle mass, reduced hand grip strength and prolonged TUG were present in 23.1%, 41% and 40.5%, respectively, of the cohort. The hand grip test had good correlation with lean muscle evaluation and the TUG. Conclusions: Sarcopenia was prevalent in 18% of maintenance haemodialysis patients from an Australian single-centre cohort, with low serum albumin and phosphate as significant risk factors.

Comparison of the accuracy of measuring blood glucose in whole blood of arteriovenous mixed blood by two kinds of blood glucose meters

BACKGROUND: Portable blood glucose meters are the main method for detecting the blood glucose status of clinical patients. OBJECTIVE: To investigate the accuracy of detecting blood glucose in haemodialysis patients by sampling two blood glucose meters through the haemodialysis line. METHODS: Convenient sampling was used to select 80 patients with maintenance haemodialysis. The patients were sampled through the arterial end of the haemodialysis line within three minutes of being put on the machine. One specimen was tested by glycemeter1, which can identify the type of blood in the arteries and veins, and glycemeter2, which can only detect blood glucose in the capillaries for bedside blood glucose testing. The other specimen was sent to the laboratory biochemical analyser for blood glucose testing. RESULTS: When the blood glucose value of the first blood glucose meter (No. 1) was compared with the laboratory biochemical analyser, the correlation coefficient was r = 0.805 (p < 0.05), the out of value of the first blood glucose meter accounted for 4.4%, and the consistency reached 95% (p < 0.05). When the blood glucose value of the second blood glucose meter (No. 2) was compared with the laboratory biochemical analyser, the correlation coefficient was r = 0.800 (p < 0.05), the out of value of the second blood glucose meter accounted for 4.4%, and the consistency reached 95% (p < 0.05). CONCLUSIONS: For patients with maintenance haemodialysis, the blood glucose values detected by the two bedside blood glucose meters using arteriovenous mixed blood in the pipeline do not affect the accuracy and can respond more realistically.

Citric Acid-Based Bicarbonate Dialysate Attenuates Aortic Arch Calcification in Maintenance Haemodialysis Patients: An Observational Study

Introduction: The progression of aortic calcification is associated with mortality in haemodialysis patients. Blood calciprotein particle (CPP) levels are associated with coronary artery calcification, and was reported to be inhibited when using citric acid-based bicarbonate dialysate (CD). Therefore, we examined the effect of CD on the progression of the aortic arch calcification score (AoACS) and blood CPP levels in haemodialysis patients.Methods: A 12-month retrospective observational study of 262 haemodialysis patients who met the eligibility criteria was conducted at Joban Hospital. Patients taking warfarin or bisphosphonates and those with baseline AoACS of 100% were excluded. Progression, defined as ΔAoACS (12 months – baseline) > 0%, was compared between the CD and acetic acid-based bicarbonate dialysate (AD) groups.Results: The CD group had significantly lower AoACS progression than the AD group (P = 0.037). ΔCPP and ΔAoACS were not correlated in the AD group (R2 = 0.030, P = 0.098), but were negatively correlated in the CD group (R2 = 0.065, P = 0.022). Multivariate logistic analysis showed that the CD (odds ratio [OR] 0.51, 95% confidence interval [CI] 0.27‒0.97, P = 0.042) was significantly associated with the AoACS progression.Conclusion: CD may suppress the progression of vascular calcification in haemodialysis patients.