Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD ...treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD.
This trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy.
This clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD.
NCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020).
It is important to understand the unique aspects vis-à-vis protein-energy wasting for patients undergoing PD. As a result of obligatory protein losses with the therapy, the serum albumin levels of ...patients undergoing PD are lower, as is the threshold serum albumin at which the risk for death is increased. Consequently, it is prudent to consider a lower threshold for serum albumin for the diagnosis of protein-energy wasting for patients undergoing PD. Likewise, it is important to consider the energy intake from obligatory nutrient absorption in the form of carbohydrates when estimating total energy intake (diet and dialysate) when evaluating patients for protein-energy wasting. The continuous nature of PD also has important therapeutic implications for protein-energy wasting. Such patients are more likely to have a complete correction of metabolic acidosis, and glucose absorption from the peritoneal dialysate has a protein-sparing effect, allowing some patients to maintain neutral nitrogen balances in the face of suboptimal protein intake. In contrast, clinical trials of amino-acid-based PD solutions have not met expectations and cannot be recommended for routine use for treatment of protein-energy wasting. In conclusion, it is important to consider these unique nutritional considerations when providing care to patients undergoing PD.
Background The association of survival with characteristics of thrice-weekly hemodialysis (HD) treatment, including dose or duration of treatment, has not been completely elucidated, especially in ...different race and sex categories. Study Design We examined associations of time-averaged and quarterly varying (time-dependent) delivered HD dose and treatment time and 5-year (July 2001-June 2006) survival. Setting & Participants 88,153 thrice-weekly–treated HD patients from DaVita dialysis clinics. Predictors HD treatment dose (single-pool Kt/V) and treatment time. Outcomes & Other Measurements 5-Year mortality. Results Thrice-weekly treatment time < 3 hours (but ≥ 2.5 hours) per HD session compared with ≥ 3.5 hours (but < 5 hours) was associated with increased death risk independent of Kt/V dose. The greatest survival gain of higher HD dose was associated with a Kt/V approaching the 1.6-1.8 range, beyond which survival gain was minimal, nonexistent, or even tended to reverse in African American men and those with 4-5 hours of HD treatment. In non-Hispanic white women, Kt/V > 1.8 continued to show survival advantage trends, especially in time-dependent models. Limitations Our results may incorporate uncontrolled confounding. Achieved Kt/V may have different associations than targeted Kt/V. Conclusions HD treatment dose and time appear to have different associations with survival in different sex or race groups. Randomized controlled trials may be warranted to examine these associations across different racial and demographic groups.
Cardiovascular mortality has remained high in patients on peritoneal dialysis (PD) due to the high prevalence of various cardiovascular complications including coronary artery disease, left ...ventricular hypertrophy and dysfunction, heart failure, arrhythmia (especially atrial fibrillation), cerebrovascular disease, and peripheral arterial disease. In addition, nearly a quarter of PD patients develop sudden cardiac death as the terminal life event. Thus, it is essential to identify effective treatment that may lower cardiovascular mortality and improve survival of PD patients. The International Society for Peritoneal Dialysis (ISPD) commissioned a global workgroup in 2012 to formulate a series of recommendation statements regarding lifestyle modification, assessment and management of various cardiovascular risk factors, and management of the various cardiovascular complications to be published in 2 guideline documents. This publication forms the second part of the guideline documents and includes recommendation statements on the management of various cardiovascular complications in adult chronic PD patients. The documents are intended to serve as a global clinical practice guideline for clinicians who look after PD patients. We also define areas where evidence is clearly deficient and make suggestions for future research in each specific area.
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NUK, OILJ, SAZU, UKNU, UL, UM, UPUK
To date, there are no known estimates of the prevalence of chronic kidney disease within Cambodia, the vast majority of whose citizens live in rural areas with limited access to renal replacement ...therapy.
Observational analysis of patients from the Takeo province in Cambodia who presented to MoPoTsyo, a non-governmental organization, for screening and management of diabetes mellitus between 2010 and 2012 (n = 402; 75% females). Estimated glomerular filtration rate (eGFR) was calculated using the CKD-Epi equation.
On average, women were younger, with a higher percentage of hypercholesterolemia but also high-density lipoprotein level. Men had a higher serum creatinine level (1.31 mg/dl) than that of women (1.13 mg/dl) at 95% CI. More than half of all screened patients had a reduced eGFR; 60% (95% CI 55%, 65%) had an eGFR<60 ml/min/1.73 m(2); 54% (49%, 59%) had an eGFR 30-60 ml/min/1.73 m(2), and 5.7% (3.4%, 8.0%) with eGFR 15-30 ml/min/1.73 m(2). Women had a greater prevalence of stage 3 CKD (57% women vs. 47% men) and stage 4 CKD (7.0% vs. 2.0%). The adjusted odds ratio for females compared to males having an eGFR <60 ml/min/1.73 m(2) was 3.19 (95% CI 1.78, 5.43; p value<0.001). Thirty-two percent of patients lost ≥ 5 ml/min/1.73 m2 eGFR during median follow-up time of 433 days (IQR 462 days) days.
Over one-half of Cambodians with diabetes mellitus had reduced eGFR, implying a point-prevalence of chronic kidney disease of 1.2% in among adult Cambodians within the country. This high burden of kidney disease in a society that lacks universal access to renal replacement therapy underscores the importance of early diagnosis - a largely unmet need in Cambodia.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The influence of pretransplant dialysis modality on post-transplant outcomes is not clear. This study examined associations of pretransplant dialysis modality with post-transplant outcomes in a large ...national cohort of kidney transplant recipients.
Linking the 5-year patient data of a large dialysis organization to the Scientific Registry of Transplant Recipients, 12,416 hemodialysis and 2092 peritoneal dialysis patients who underwent first kidney transplantation were identified. Mortality or graft failure and delayed graft function risks were estimated by Cox regression (hazard ratio) and logistic regression (odds ratio), respectively.
Recipients treated with peritoneal dialysis pretransplantation had lower (21.9/1000 patient-years 95% confidence interval: 18.1-26.5) crude all-cause mortality rate than those recipients treated with hemodialysis (32.8/1000 patient-years 30.8-35.0). Pretransplant peritoneal dialysis use was associated with 43% lower adjusted all-cause and 66% lower cardiovascular death. Furthermore, pretransplant peritoneal dialysis use was associated with 17% and 36% lower unadjusted death-censored graft failure and delayed graft function risk, respectively. However, after additional adjustment for relevant covariates, pretransplant peritoneal dialysis modality was not a significant predictor of death-censored graft failure delayed graft function, respectively. Similar trends were noted on analyses using a propensity score matched cohort of 2092 pairs of patients.
Compared with hemodialysis, patients treated with peritoneal dialysis before transplantation had lower mortality but similar graft loss or delayed graft function. Confounding by residual selection bias cannot be ruled out.
Abstract Aims To determine if serum levels of serum amyloid A (SAA) predict death and end-stage renal disease in a cohort of people with diabetic kidney disease. Methods In a longitudinal cohort ...study of 135 participants with type 2 diabetes and diabetic kidney disease, serum samples were assayed for SAA. Censored time-to-event analyses in Cox-proportional hazard models were utilized to assess SAA as a predictor of the primary outcome of death and end-stage renal disease. Results Participants were 73% Mexican-American (99/135) and 55% men (75/135), with a mean ± SD age of 57 ± 7.5 years. At baseline, participants had hemoglobin A1c of 8.6 ± 2.3%, systolic blood pressure of 153 ± 27 mm Hg, body mass index of 31 ± 9 kg/m2 , median urine-albumin-to-creatinine ratio of 1861 mg/g (interquartile range 720–3912 mg/g), and estimated glomerular filtration rate of 55.7 ± 22.3 ml/min/1.73m2 . Over a median duration of follow-up of 3.5 years, 44% (60/135) of participants experienced a primary outcome event. The hazards ratio for the primary outcome was 3.03 (95% CI 1.43–6.40, p = 0.003) in the highest (> 1.0 μg/ml) compared to the lowest (< 0.55 μg/ml) SAA tertile in a model adjusted for urine-albumin-to-creatinine ratio, estimated glomerular filtration rate, age, sex, and race/ethnicity. Addition of SAA as a covariate improved the model C-statistic (Δ c = 0.017). Conclusions In a longitudinal cohort study of participants with type 2 diabetes and DKD, higher levels of serum SAA predicted higher risk of death and ESRD. SAA is a promising targetable biomarker for DKD.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
In the past decade, peritoneal dialysis use among patients with end-stage renal disease has declined in many countries. Studies from the United States indicate that many academic centers do not have ...adequate resources to train fellows, most incident dialysis patients are not offered peritoneal dialysis, and more than half of dialysis clinics do not have the infrastructure to support peritoneal dialysis. Some are concerned that the outcomes of peritoneal dialysis and maintenance hemodialysis patients may not be equivalent, a notion that is not supported by outcome studies. Given the effect of modality selection on patients' lifestyle, attempts to conduct a randomized, controlled comparison of maintenance hemodialysis and peritoneal dialysis have been unsuccessful. Most observational studies showed that peritoneal dialysis is associated with a survival advantage that diminishes over time; it is unclear whether any of the differences over time are attributable to the modality. Between 1996 and 2003, the early outcomes of peritoneal dialysis patients further improved, whereas those for maintenance hemodialysis patients remained unchanged. Differences in outcomes may be due to residual statistical confounding; however, several biologic mechanisms can be postulated: The early survival advantage may be related to the better preservation of residual renal function with peritoneal dialysis, and the diminution of the survival advantage may be related to worsened volume control. There is a need for large observational and interventional studies among peritoneal dialysis patients to sustain and enforce the improvements in both dialysis therapies.
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