Prevalence of Asymptomatic COVID-19 Infection in Hemodialysis Patients and the Risk of Hypercoagulability: Should we Consider Routine Screening?

Introduction: Coronavirus disease 2019 (COVID-19) has become a pandemic in late 2019. Its clinical presentation varies from asymptomatic infection to severe respiratory failure. Infection control strategies to minimize the risk of transmission of COVID-19 in end-stage renal disease (ESRD) patients receiving in-center hemodialysis (HD) have been implemented. Development of humoral response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adult patients with ESRD receiving HD has not been sufficiently reported. Methods: A total of 179 asymptomatic HD patients undergoing regular HD were screened for COVID-19 infection. Infection with SARS-CoV-2 was confirmed through a real-time reverse transcription polymerase chain reaction assay of nasopharyngeal swab specimens. They were classified into positive and negative groups according to the results of PCR. Results: Of the 179 asymptomatic patients, we found that 23 patients (12.8%) were positive for COVID-19. Their mean age was 45.61 ± 13.38 years. There was a significant difference between both groups regarding C-reactive protein, lymphocytes, and platelet counts (P < 0.001). Also, TAT (thrombin-antithrombin complex) and D-dimer levels were significantly increased among the positive group (11.47 ± 1.51 vs. 7.53 ± 1.64 mcq/L, P < 0.001; 1171.52 ± 267.6 vs. 542.76 ± 107.06 ng/mL, P < 0.001, respectively). Conclusion: Asymptomatic SARS-CoV-2 infection is detected in HD patients. They carry the risk of hypercoagulability complications. We need more strict infection control measures and proactive diagnosis to limit the spread of the infection and lethal thromboembolic complications.

COVID-19 Infection in Hemodialysis Patients, Incidence, Risk Factors and Mortality. Single Centre Study

Background: Hemodialysis patients are not only prone to acquire COVID-19 infection but also more likely to suffer a higher rate of morbidity and mortality. This study aims to report the incidence and mortality rate of COVID-19 infection in our hemodialysis patients and to determine risk factors. Methods: This is an observational, retrospective study conducted in the dialysis unit of Dubai Hospital. Our target population was hemodialysis patients who tested positive for COVID infection (PCR assay of the nasopharyngeal swab) from 1st April 2020 to 31st August 2021. Our primary outcome was to study the mortality rate associated with COVID-19 infection in dialysis patients in Dubai hospital. Our secondary objectives were to study the incidence and determine risk factors for the severity of infection. Patient demographics and clinical features were collected from medical record software, i.e., EPIC. Univariate Cox regression analysis was performed to evaluate potential risk factors for mortality in our cohort. Results: 72 out of 250 (28.8%) hemodialysis patients acquired COVID infection during the study period, the median age was 54.32 (15-93) years, and 56.94% (n=41) were male. The most common comorbid was hypertension (59.72%), while the main symptom at presentation was shortness of breath (25%). One-third of patients required a different form of oxygen therapy, and 11.11% of patients were mechanically ventilated. The mortality rate was 16.6%. High median age, ischemic heart disease, low absolute lymphocyte count, and high levels of ferritin, LDH, and procalcitonin, as well as mechanical ventilation, were statistically significant risk factors associated with mortality. Conclusion: The overall outcome of COVID infection in our hemodialysis patients was better compared to the hemodialysis population from other parts of the world. © 2022 Ram et al.

Home Hemodialysis: Core Curriculum 2021.

In the early days of dialysis, because of a lack of existing in-center infrastructure, home hemodialysis (HHD) was frequently used to expand dialysis programs. Recently, HHD has been thrust into the spotlight of kidney care programs once again. Patients and policymakers are demanding more choices for the management of kidney failure while controlling for cost. Perhaps it is not surprising that the kidney community's interest in HHD has been revived, especially during the COVID-19 pandemic. To meet this increased interest and demand, nephrologists and dialysis providers must embrace new technologies and improve their understanding of HHD systems. This installment of AJKD's Core Curriculum in Nephrology seeks to inform the reader about factors that can improve success in the training and retention of HHD patients. Benefits, pitfalls, and challenges of HHD are outlined. The features of novel and commonly used HHD equipment are also summarized. Examples of prescriptions and prescription adjustments to meet the needs of patients will also be reviewed. Finally, considerations related to medical management of HHD patients and their dialysis access at home are also included. HHD is an important tool for the management and rehabilitation of patients with kidney failure, which allows for patient-centered care and increased patient choice.

Image-guided tunneled peritoneal dialysis catheter placement.

Patients with end-stage renal disease (ESRD) often will ultimately require dialysis to survive. One type of dialysis is peritoneal dialysis (PD), which utilizes the vessel-rich peritoneum as a semi-permeable membrane to filter blood. In order to perform PD, a tunneled catheter must be placed through the abdominal wall and into the peritoneal space, with ideal positioning of the catheter within the most dependent portion of the pelvis, represented by the rectouterine or rectovesical space in women and men, respectively. There are several approaches to PD catheter insertion, including open surgical, laparoscopic surgical, blind percutaneous, and image-guided with the use of fluoroscopy techniques. Interventional radiology (through the use of image-guided percutaneous techniques) is an infrequently utilized resource to place PD catheters, and offers real-time imaging confirmation of catheter positioning with similar outcomes to more invasive surgical catheter insertion approaches. Although the vast majority of dialysis patients receive hemodialysis instead of peritoneal dialysis in the United States, some countries have moved towards a "Peritoneal Dialysis First" initiative, prioritizing initial PD, as it is less burdensome on healthcare facilities as it can be performed at home. In addition, the outbreak of the COVID-19 pandemic has produced shortages of medical supplies and delays in care delivery worldwide, while simultaneously generating a shift away from in-person medical visits and appointments. This shift may be met with more frequent utilization of imaged-guided PD catheter placement, reserving surgical and laparoscopic placement for complex patients who may require omental periprocedural revisions. This literature review outlines a brief history of PD, the various techniques of PD catheter insertion, patient selection criteria, and new COVID-19 considerations, in anticipation for the increased demand for PD in the United States.

Co-infection of coronavirus disease 19 and cytomegalovirus in a kidney transplant recipient.

It has been suggested that severe SARS-CoV-2 infection could be a risk factor for Herpesviridae reactivation due to the state of sepsis-associated immunosuppression. We presented the case of co-infection of CMV and COVID-19 infection in a 43-year-old woman with end-stage renal disease.

Clinical presentation and outcomes of chronic kidney disease patients with COVID-19 admitted to the intensive care unit of a teaching hospital of Northern India during the third wave of the pandemic: A retrospective study.

Introduction: Chronic kidney disease (CKD) patients have impaired immune status; that's why these patients are prone to develop infection-related complications. The current study compares non-haemodialysis chronic kidney disease and end-stage renal disease (NO-HD-CKD and ESRD, respectively) patient outcomes, the data of which is sparse. Methods: Patients diagnosed with COVID-19 infection through reverse transcriptase polymerase chain reaction (RT-PCR) were retrospectively studied using electronic health records. Patients were divided into three categories: non-chronic kidney disease (NO-CKD), NO-HD-CKD, and ESRD, and the outcome was assessed. Results: Out of 745 patients, 92 (12.34%) had NO-HD-CKD and 31 (4.16%) had ESRD. CKD patients who were not on haemodialysis had higher rates of comorbidities and D-dimer and C-reactive protein (CRP) values compared to ESRD patients. The overall unadjusted mortality rate was found to be 17.44%, and it was 10.45% in case of NO-CKD patients, 58.69% for NO-HD-CKD patients, and 48.39% for ESRD patients. It was observed that patients having NO-HD-CKD had greater odds ratio of overall expiry in comparison to those without CKD in univariate analysis (OR: 1.58; 95% CI: 1.31-1.91). It was not significant in fully adjusted models (OR: 1.11; 95% CI: 0.88-1.40). Conclusions: During the third wave of COVID-19, we found higher mortality rates for cases with NO-HD-CKD and, to a lower extent, ESRD. However, patients with ESRD were observed to have good outcomes in comparison to those with NO-HD-CKD. Primary care physicians are the first point of contact for patients. Hence, it is critical for them to manage and to do proper referral of comorbid patients to higher centres.

EXPERIENCES OF HEMODIALIZED PATIENTS WHO HAVE RECOVERED FROM COVID-19 IN MEDAN CITY

Hemodialysis is one of the appropriate treatments for patients with ESRD. The glomerular filtration rate in the kidneys decreased to <60 mL/min and the creatinine and albumin values in the patient's urine increased to >30 mg/g, so that patients with chronic kidney failure had to undergo a treatment to balance and replace the work of the kidneys, namely the hemodialysis process. The research design used in this study is a descriptive phenomenological design. Phenomenology is a method that seeks to find the essence and meaning of phenomena as they are experienced, especially through in-depth interviews with people who have had relevant experiences. In this study, the characteristics of participants were obtained based on the demographic data obtained, where the average age of hemodialysis participants who were positively exposed to COVID-19 was more likely to be under 50 years old, with 7 participants, and 4 participants over 50 years old. . The gender of hemodialysis participants in this study was found to be 6 men and 5 women. Another characteristic that was obtained was that the ethnic groups that participated in this study were, the Batak tribe numbered 6 people, Karo 1 person, Malay 1 person, Padang 1 person and Javanese 1 person. The religion of the participants in this study, it was found that 2 Protestant Christians, 8 Muslims, and 1 Catholic Christian. [ FROM AUTHOR]

Molnupiravir When Used Alone Seems to Be Safe and Effective as Outpatient COVID-19 Therapy for Hemodialyzed Patients and Kidney Transplant Recipients.

BACKGROUND: Molnupiravir demonstrated an in vitro antiviral activity against positive-sense RNA viruses, including SARS-CoV-2. The study aimed to present the results of outpatient molnupiravir use in kidney transplant recipients and hemodialysis patients during the first months of 2022 in Poland. METHODS: The retrospective observational cohort study at one kidney transplant center included 36 patients diagnosed with COVID-19 with an automated nucleic acid amplification test on nasopharyngeal swab specimens. All patients received molnupiravir for home-based therapy at a dose of 800 mg every 12 h orally for 5 days. Both kidney transplant recipients (n = 16) and hemodialysis patients (n = 20) presented a lot of comorbidities with a Charlson comorbidity index of 4.1 and 5.1, respectively. RESULTS: Patients presented with fever, cough, and weakness followed by muscle and joint pain. Five kidney transplant recipients experienced acute kidney injury with a rise in serum creatinine level from 0.4 to 1.9 mg/dL. No serious side effects of molnupiravir therapy or interactions with immunosuppressive medications were observed. Symptoms of COVID-19 improved rapidly or resolved within 24-48 h of starting treatment. CONCLUSION: The study suggests the safety and efficacy of molnupiravir therapy alone early after the onset of SARS-CoV-2 infection, but further investigations should be performed to confirm our preliminary results. To the best of the authors' knowledge, it is the first published report on molnupiravir use in end-stage kidney disease (ESKD) patients on hemodialysis and the third concerning kidney transplant recipients.

Two Cases of Autoimmune Thyroid Disorders after COVID Vaccination in Dialysis Patients.

SARS-CoV-2 infection and vaccination have been associated with autoimmune thyroid dysfunctions. Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) and molecular mimicry have been referred to as potential causes. Such a case has not been reported in immunocompromised end-stage renal disease (ESRD) patients. Herein we present two dialysis patients with no previous history of thyroid disease who developed immune mediated thyroid disorders after BNT162b mRNA vaccine against SARS-CoV-2. The first patient is a 29-year-old man on hemodialysis diagnosed with Grave's disease four months post-vaccination and the second one is a 67-year-old female on peritoneal dialysis who developed Hashimoto's thyroiditis two months post-vaccination. Grave's disease is uncommon in dialysis patients, whereas Hashimoto's thyroiditis has a higher incidence in this population. Time proximity in both cases suggests potential causality. To our knowledge, this is the first report of de novo immune-mediated thyroid disorders in dialysis patients following vaccination against SARS-CoV-2.

Associations of COVID-19 Outcomes with Dialysis Modalities and Settings.

How maintenance dialysis modality, dialysis setting, and residence in a nursing facility have jointly associated with coronavirus disease 2019 (COVID-19)-related outcomes in the United States is relevant to future viral outbreaks. Using Medicare claims, we determined the incidence of COVID-19-related infection, hospitalization, and death between March 15, 2020 and June 5, 2021. The exposure was one of five combinations of dialysis modality and care setting: in-facility hemodialysis without a recent history of skilled nursing facility care, in-facility hemodialysis with a recent history of skilled nursing facility care, hemodialysis in a skilled nursing facility, home hemodialysis, and (home) peritoneal dialysis. Patient-weeks were pooled to estimate the adjusted associations of event incidence with each dialysis modality/setting during four intervals in 2020-2021. Relative to in-facility hemodialysis without a recent history of skilled nursing facility care, home dialysis was associated with 36%-60% lower odds of all events during weeks 12-23 of 2020; 24%-37% lower odds of all events during weeks 24-37 of 2020; 20%-33% lower odds of infection and hospitalization during the winter of 2020-2021; and similar odds of all events thereafter. In contrast, exposure to skilled nursing facilities was associated with 570%-1140% higher odds of all events during spring of 2020, although excess risk attenuated as the pandemic transpired, especially among patients who received hemodialysis in skilled nursing facilities. In conclusion, home dialysis was associated with lower risks of COVID-19 diagnosis, hospitalization, and death until vaccines were available, whereas care in skilled nursing facilities was associated with higher risks.

Impact of Acid Suppression Therapy on Renal and Survival Outcomes in Patients with Chronic Kidney Disease: A Taiwanese Nationwide Cohort Study.

Histamine-2-receptor antagonist (H2RA) has shown beneficial effects on the kidney, heart, and sepsis in animal models and on the heart and COVID-19 infection in clinical studies. However, H2RAshave been used as a reference in most epidemiological studies examining the association of proton pump inhibitors (PPI) with outcomes. Therefore, we aimed to evaluate the effect of H2RA on renal and survival outcomes in chronic kidney disease (CKD) patients. We used a Taiwanese nationalhealth insurance database from 2001 to 2016 to screen 45,767 CKD patients for eligibility. We identified new users of PPI (n = 7121), H2RA (n = 48,609), and users of neither PPI nor H2RA (as controls) (n = 47,072) during follow-up, and finally created 1:1:1 propensityscore-matchedcohorts; each cohort contained 4361 patients. Participants were followed up after receivingacid-suppression agents or on the corresponding date until the occurrence of end-stage renal disease (ESRD) in the presence of competing mortality, death, or through the end of 2016. Compared toneither users, H2RAand PPI users demonstrated adjusted hazard ratios of 0.40 (95% confidence interval, 0.30-0.53) for ESRDand 0.64 (0.57-0.72) for death and 1.15 (0.91-1.45) for ESRD and 1.83 (1.65-2.03) for death, respectively. A dose-response relationship betweenH2RA use with ESRD and overall, cardiovascular, and non-cardiovascular mortality was detected. H2RA consistently provided renal and survival benefits on multivariable stratified analyses and multiple sensitivity analyses. In conclusion, dose-dependent H2RA use was associated with a reduced risk of ESRD and overall mortality in CKD patients, whereas PPI use was associated with an increased risk of overall mortality, not in a dose-dependent manner.

ChAdOx1 nCoV-19 Immunogenicity and Immunological Response Following COVID-19 Infection in Patients Receiving Maintenance Hemodialysis.

Patients with end-stage renal disease (ESRD) receiving hemodialysis (HD) were found to have a decreased immune response following mRNA COVID-19 immunization. ChAdOx1 nCoV-19 was a promising COVID-19 vaccine that performed well in the general population, but the evidence on immunogenicity in ESRD with HD patients was limited. Moreover, the immunological response to COVID-19 infection was inconclusive in patients with ESRD and HD. The aim of this study was to investigate the immunogenicity of ChAdOx1 nCoV-19 vaccination and the immunological response after COVID-19 infection in ESRD patients with HD. The blood samples were obtained at baseline, 1-month, and 3-month follow-up after each shot or recovery. All participants were measured for anti-spike IgG by the ELISA method, using Euroimmun. This study found a significant increase in anti-spike IgG after 1 month of two-shot ChAdOx1 nCoV-19 vaccination, followed by a significant decrease after 3 months. On the other hand, the anti-spike IgG was maintained in the post-recovery group. There was no significant difference in the change of anti-spike IgG between the one-shot ChAdOx1 nCoV-19-vaccinated and post-recovery groups for both 1-month and 3-month follow-ups. The seroconversion rate for the vaccinated group was 60.32% at 1 month after one-shot vaccination and slightly dropped to 58.73% at the 3-month follow-up, then was 92.06% at 1 month after two-shot vaccination and reduced to 82.26% at the 3-month follow-up. For the recovered group, the seroconversion rate was 95.65% at 1 month post-recovery and 92.50% at 3-month follow-up. This study demonstrated the immunogenicity of two-dose ChAdOx1 nCoV-19 in ESRD patients with HD for humoral immunity. After COVID-19 infection, the humoral immune response was strong and could be maintained for at least three months.

COVID-19 Vaccine Efficacy and Immunogenicity in End-Stage Renal Disease Patients and Kidney Transplant Recipients.

Purpose of Review: To summarize the current literature with respect to COVID-19 vaccine efficacy patients with end-stage renal disease on dialysis and kidney transplant recipients. Recent Findings: Immunosuppressed patients are at greater risk of morbidity and mortality from COVID-19 infection. Patients with ESRD and KTR are immunosuppressed and mount a weaker antibody response to COVID-19 mRNA vaccination, and factors including immunosuppressant medications have been implicated for this weakened response. Third and fourth doses of vaccine doses have been shown to increase seropositivity and antibody production in kidney transplant recipients and patients on dialysis. Retrospective studies have demonstrated decreased mortality in vaccinated, immunosuppressed patients. Summary: ESRD and KTR patients have decreased antibody response to COVID-19 vaccines, but third and fourth doses have been shown to increase antibody production. Though a correlate of protection between antibody production and efficacy has yet to be fully established in this subset of the population, all US professional bodies who treat ESRD and KTR patients advocate for full vaccination against SARS-CoV-2 based on the data available. Studies demonstrating decreased mortality in vaccinated patients are promising on efficacy. Importantly, because KTR patients mount a weaker antibody response than ESRD patients, vaccination prior to kidney transplantation is critical.

Peritoneal catheter insertion: combating barriers through policy change.

Barriers to accessing home dialysis became a matter of life and death for many patients with kidney failure during the coronavirus disease 2019 (COVID-19) pandemic. Peritoneal dialysis (PD) is the more commonly used home therapy option. This article provides a comprehensive analysis of PD catheter insertion procedures as performed around the world today, barriers impacting timely access to the procedure, the impact of COVID-19 and a roadmap of potential policy solutions. To substantiate the analysis, the article includes a survey of institutions across the world, with questions designed to get a sense of the regulatory frameworks, barriers to conducting the procedure and impacts of the pandemic on capability and outcomes. Based on our research, we found that improving patient selection processes, determining and implementing correct insertion techniques, creating multidisciplinary teams, providing appropriate training and sharing decision making among stakeholders will improve access to PD catheter insertion and facilitate greater uptake of home dialysis. Additionally, on a policy level, we recommend efforts to improve the awareness and feasibility of PD among patients and the healthcare workforce, enhance and promulgate training for clinicians-both surgical and medical-to insert PD catheters and fund personnel, pathways and physical facilities for PD catheter insertion.

COVID-19 in Hemodialysis Patients: Experience from a Western Indian Center.

Introduction: Chronic kidney disease patients on hemodialysis (CKD-5D) are among the worst hit by the coronavirus disease 2019 (COVID-19) pandemic. Need to travel for dialysis, comorbidities, and immunosuppressive state put them at risk of severe disease and poor outcomes. We report our experience of COVID-19 in a cohort of CKD-5D from a public sector tertiary-care center from western India. Material and Methods: We retrospectively analyzed the records of 58 CKD-5D patients with confirmed COVID-19 admitted to our COVID-19 hospital. Suspected COVID-19, acute kidney injury (AKI), or AKI on CKD were excluded. We studied the clinical, demographic, radiological, and laboratory profiles; treatment; and outcomes of the patients. We assessed the potential clinical and laboratory parameters to predict mortality. Results: The mean age of the patients was 48.7 ± 16.9 years, with 55% males. Comorbidities included hypertension (65%), diabetes (19%), and cardiovascular disease (15.5%). The presenting features included fever (69%), respiratory distress (50%), upper respiratory symptoms (36%), and diarrhea (13%). Five (8.6%) were asymptomatic. Bilateral infiltrates on chest imaging were the commonest radiological pattern. The patients were managed with oxygenation, hydroxychloroquine, steroids, anticoagulation, remdesivir, and favipiravir. Twenty-two (37.9%) patients died, predominantly due to respiratory failure. Disease severity and C-reactive protein (CRP) above 175 mg/L at admission were the only parameters predictive of mortality. Conclusion: CKD-5D patients with COVID-19 were less likely to present with the classical syndrome of fever and respiratory distress compared with reports from the general population and had higher mortality. Only disease severity and high CRP (>175 mg/L) were predictive of mortality in our cohort.

Immunogenicity of COVID-19 Vaccination in Patients With End-Stage Renal Disease Undergoing Maintenance Hemodialysis: The Efficacy of a Mix-and-Match Strategy.

BACKGROUND: The objective of this study was to evaluate the immunogenicity of coronavirus disease 2019 (COVID-19) vaccination in patients with end-stage renal disease (ESRD) on hemodialysis. METHODS: ESRD patients at the hemodialysis center of a tertiary-care university-affiliated hospital and healthy employees at the clinical laboratory center were prospectively recruited between March and June 2021. For severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody analysis, blood samples were collected serially on days 0, 14, 28, and 56 after the first vaccine dose, and on days 7 and 50 after the second dose. Antibodies against the SARS-CoV-2 spike protein were quantified, and SARS-CoV-2 neutralizing antibodies were measured in the serum and plasma. RESULTS: Thirty-one ESRD patients and 55 healthy employees were regularly monitored. Twenty-five (80.6%) ESRD patients on hemodialysis received a mix-and-match strategy with ChAdOx1-BNT162b2 (AZ-Pf group) and six (19.4%) received two doses of ChAdOx1 (AZ-AZ group). ESRD patients on hemodialysis showed lower binding antibody titers and neutralizing antibody activities compared to healthy participants following the first vaccination with ChAdOx1. After the second dose, AZ-Pf group had higher immunogenicity than healthy people on days 7 and 50. The binding antibody titer and neutralizing antibody activities on days 7 and 50 were significantly higher in the AZ-Pf group than in the AZ-AZ group. CONCLUSION: ESRD patients on hemodialysis receiving the mix-and-match strategy (ChAdOx1-BNT162b2) have COVID-19 vaccine immunogenicity comparable to healthy individuals receiving two doses of ChAdOx1. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04871945.

Case Report: Severe SARS-CoV-2 Infection Treated with Remdesivir in a Patient with ESRD.

BACKGROUND: The novel coronavirus disease 2019 (COVID-19) has led to a global pandemic since its emergence from Wuhan, China, in December of 2019. As research continues to evolve, there is a paucity of reports describing the management and treatment of COVID-19 in patients with acute kidney failure and End-Stage Renal Disease (ESRD). These patients have increased susceptibility to developing severe clinical symptoms from SARS-CoV-2 infection due to their underlying comorbidities. Remdesivir has emerged as a promising antiviral drug against SARS-CoV-2. However, data regarding the clinical benefits of remdesivir in patients with severe renal impairment is unavailable as they have been excluded from clinical trials due to the risk of sulfobutylether-ß-cyclodextrin (SBECD) accumulation in patients with eGFR<30 ml/min per 1.73m2. CASE PRESENTATION: We present the first case of a 47-year-old male with end-stage renal disease who was successfully treated with remdesivir during hospitalization for acute respiratory distress syndrome and respiratory failure arising from COVID-19. The worsening clinical progress of the patient despite intensive care and treatment with intravenous azithromycin therapy led to the decision to utilize remdesivir after a risk-benefit analysis, despite his eGFR being <15 ml/min per 1.73m2. Although the patient developed reversible hepatotoxicity, marked improvement of symptoms was observed after the five-day course of remdesivir was completed. CONCLUSION: Our findings describe the first instance of compassionate use of remdesivir for the treatment of COVID-19 in the setting of end-stage renal disease, acute respiratory distress syndrome, and hypoxemic respiratory failure.

No additional benefit of prescribing a very low-protein diet in patients with advanced chronic kidney disease under regular nephrology care: a pragmatic, randomized, controlled trial.

BACKGROUND: Whether a very low-protein diet supplemented with ketoanalogues (sVLPD), compared with a standard low-protein diet (LPD), improves outcomes in patients with chronic kidney disease (CKD) under stable nephrology care is undefined. OBJECTIVES: To compare the effectiveness of sVLPD compared with LPD in patients regularly seen in tertiary nephrology care. METHODS: Participants were patients with CKD stages 4-5, followed for at least 6 mo, randomly allocated to receive sVLPD or LPD [0.35 or 0.60 g/kg ideal body weight (IBW)/d, respectively], stratified by center and CKD stage. The primary outcome was time to renal death, defined as the first event between end-stage renal disease (ESRD) and all-cause mortality; secondary outcomes were the single components of the primary outcome, cardiovascular outcome, and nutritional status. RESULTS: We analyzed 223 patients (sVLPD, n = 107; LPD, n = 116). Mean age was 64 y, 61% were male, and 35% had diabetes. Median protein intake (PI), which was 0.8 g/kg IBW/d at baseline in both groups, was 0.83 and 0.60 g/kg IBW/d in LPD and sVLPD, respectively, during the trial with a large decrease only in sVLPD (P = 0.011). During a median of 74.2 mo, we recorded 180 renal deaths (141 dialysis and 39 deaths before dialysis). Risk of renal death did not differ in sVLPD compared with LPD (HR: 1.17; 95% CI: 0.88, 1.57; P = 0.28). No difference was observed for ESRD (HR: 1.12; 95% CI: 0.81, 1.56; P = 0.51), mortality (HR: 0.95; 95% CI: 0.62, 1.45; P = 0.82), or time to fatal/nonfatal cardiovascular events (P = 0.2, log-rank test). After 36 mo, still active patients were 45 in sVLPD and 56 in LPD. No change of nutritional status emerged during the study in any arm. CONCLUSIONS: This long-term pragmatic trial found that in patients with CKD under stable nephrology care, adherence to protein restriction is low. Prescribing sVLPD compared with standard LPD is safe but does not provide additional advantage to the kidney or patient survival.

Clinical Course of SARS-CoV-2 Infection in Adults with ESKD Receiving Outpatient Hemodialysis.

Background: Patients with ESKD on maintenance dialysis receive dialysis in common spaces with other patients and have a higher risk of severe SARS-CoV-2 infections. They may have persistently or intermittently positive SARS-CoV-2 RT-PCR tests after infection. We describe the clinical course of SARS-CoV-2 infection and the serologic response in a convenience sample of patients with ESKD to understand the duration of infectivity. Methods: From August to November 2020, we enrolled patients on maintenance dialysis with SARS-CoV-2 infections from outpatient dialysis facilities in Atlanta, Georgia. We followed participants for approximately 42 days. We assessed COVID-19 symptoms and collected specimens. Oropharyngeal (OP), anterior nasal (AN), and saliva (SA) specimens were tested for the presence of SARS-CoV-2 RNA, using RT-PCR, and sent for viral culture. Serology, including neutralizing antibodies, was measured in blood specimens. Results: Fifteen participants, with a median age of 58 (range, 37‒77) years, were enrolled. Median duration of RT-PCR positivity from diagnosis was 18 days (interquartile range [IQR], 8‒24 days). Ten participants had at least one, for a total of 41, positive RT-PCR specimens ≥10 days after symptoms onset. Of these 41 specimens, 21 underwent viral culture; one (5%) was positive 14 days after symptom onset. Thirteen participants developed SARS-CoV-2-specific antibodies, 11 of which included neutralizing antibodies. RT-PCRs remained positive after seroconversion in eight participants and after detection of neutralizing antibodies in four participants; however, all of these samples were culture negative. Conclusions: Patients with ESKD on maintenance dialysis remained persistently and intermittently SARS-CoV-2-RT-PCR positive. However, of the 15 participants, only one had infectious virus, on day 14 after symptom onset. Most participants mounted an antibody response, including neutralizing antibodies. Participants continued having RT-PCR-positive results in the presence of SARS-CoV-2-specific antibodies, but without replication-competent virus detected.