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Contemporary Clinical Trials Jan 2024The HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis (HOPE Trial) is a multicenter randomized trial addressing chronic pain among patients receiving...
The HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis (HOPE Trial) is a multicenter randomized trial addressing chronic pain among patients receiving maintenance hemodialysis for end-stage kidney disease. The trial uses a sequential, multiple assignment design with a randomized component for all participants (Phase 1) and a non-randomized component for a subset of participants (Phase 2). During Phase 1, participants are randomized to Pain Coping Skills Training (PCST), an intervention designed to increase self-efficacy for managing pain, or Usual Care. PCST consists of weekly, live, coach-led cognitive behavioral therapy sessions delivered by video- or tele-conferencing for 12 weeks followed by daily interactive voice response sessions delivered by telephone for an additional 12 weeks. At 24 weeks (Phase 2), participants in both the PCST and Usual Care groups taking prescription opioid medications at an average dose of ≥20 morphine milligram equivalents per day are offered buprenorphine, a partial opioid agonist with a more favorable safety profile than full-agonist opioids. All participants are followed for 36 weeks. The primary outcome is pain interference ascertained, for the primary analysis, at 12 weeks. Secondary outcomes include additional patient-reported measures and clinical outcomes including falls, hospitalizations, and death. Exploratory outcomes include acceptability, tolerability, and efficacy of buprenorphine. The enrollment target of 640 participants was met 27 months after trial initiation. The findings of the trial will inform the management of chronic pain, a common and challenging issue for patients treated with maintenance hemodialysis. NCT04571619.
Topics: Humans; Analgesics, Opioid; Buprenorphine; Chronic Pain; Multicenter Studies as Topic; Pain Management; Randomized Controlled Trials as Topic; Renal Dialysis
PubMed: 38086444
DOI: 10.1016/j.cct.2023.107409 -
BMC Nephrology Dec 2023To explore the clinicopathologic features and outcomes of IgAN patients who presented with fibrinoid necrosis (FN) lesions or not and the effect of immunosuppressive...
BACKGROUND
To explore the clinicopathologic features and outcomes of IgAN patients who presented with fibrinoid necrosis (FN) lesions or not and the effect of immunosuppressive (IS) treatment in IgAN patients with FN lesions as well.
METHODS
This was a retrospective cohort study with 665 patients diagnosed with primary IgAN from January 2010 to December 2020 in Tianjin Medical University General Hospital and having detailed baseline and follow-up characteristics. Patients were divided into two groups depending on the appearance of FN lesions. Patients with FN lesions were recruited into Group FN1, while patients who were not found FN lesions in their renal biopsy specimens were recruited into Group FN0. Compare the differences between Group FN0 and Group FN1 in baseline clinicopathologic features, treatment solutions and follow-up data as well. To evaluate the impact of different fractions of FN lesions on baseline characteristics and prognosis of IgAN, we subdivided patients in Group FN1 into 3 groups depending on the FN lesions distribution, Mild Group: 0 < FN% < 1/16; Moderate Group: 1/16 < FN% < 1/10; Severe Group: FN% > 1/10. Furthermore, we compared the differences in baseline clinicopathologic features, treatment solutions and follow-up data among these three groups. Kidney endpoint event was defined as patients went into end-stage kidney disease (ESKD), which estimated glomerular filtration rate (eGFR) < 15 ml/min/1.73 m^2, regularly chronic dialysis over 6 months or received renal transplantation surgery. The kidney composite endpoint was defined by a ≥ 30% reduction in eGFR, double Scr increase than on-set, ESKD, chronic dialysis over 6 months or renal transplantation. Compare the survival from a composite endpoint rate in different groups by Kaplan-Meier survival curve. The univariate and multivariate Cox models were used to establish the basic model for renal outcomes in patients with FN lesions.
RESULTS
(1) A total of 230 patients (34.59%) were found FN lesions in all participants. Patients with FN lesions suffered more severe hematuria than those without. On the hand of pathological characteristic, patients with FN lesions showed higher proportions of M1, E1, C1/C2 and T1/T2 lesions compared with those without FN lesions. (2) The 1-year, 3-year, and 5-year survival of the composite endpoint were lower in the FN1 group than FN0 group. (3) After adjusting for clinicopathological variables, the presence of FN lesions was a significantly independent risk factor for composite endpoint. By using multivariate Cox regression analyses, we also found when the fraction of FN lesions exceeded 10%, the risk of progression into composite endpoint increased 3.927 times.
CONCLUSION
Fibrinoid necrosis of capillary loops is an independent risk factor of poor renal outcomes. More effective treatment should be considered for those who had FN lesions.
Topics: Humans; Glomerulonephritis, IGA; Retrospective Studies; Disease Progression; Kidney; Prognosis; Kidney Failure, Chronic; Glomerular Filtration Rate; Necrosis
PubMed: 38082385
DOI: 10.1186/s12882-023-03419-4 -
International Journal of Surgery... Mar 2024
Meta-Analysis
Topics: Humans; Renal Dialysis; Dialysis Solutions; Sodium
PubMed: 38079606
DOI: 10.1097/JS9.0000000000000985 -
International Journal of Molecular... Dec 2023Disruptions in glucose metabolism are frequently observed among patients undergoing peritoneal dialysis (PD) who utilize glucose-containing dialysis solutions. We aimed...
Disruptions in glucose metabolism are frequently observed among patients undergoing peritoneal dialysis (PD) who utilize glucose-containing dialysis solutions. We aimed to investigate the relationship between glucometabolic indices, including fasting glucose, insulin resistance, advanced glycation end products (AGEs), PD-related glucose load, and icodextrin usage, and aortic stiffness in PD patients with and without diabetic mellitus (DM). This study involved 172 PD patients (mean age 58.3 ± 13.5 years), consisting of 110 patients without DM and 62 patients with DM. Aortic stiffness was assessed using the carotid-femoral pulse wave velocity (cfPWV). Impaired fasting glucose was defined as a fasting glucose level ≥ 100 mg/dL. Homeostatic model assessment for insulin resistance (HOMA-IR) scores, serum AGEs, dialysate glucose load, and icodextrin usage were assessed. Patients with DM exhibited the highest cfPWV (9.9 ± 1.9 m/s), followed by those with impaired fasting glucose (9.1 ± 1.4 m/s), whereas patients with normal fasting glucose had the lowest cfPWV (8.3 ± 1.3 m/s), which demonstrated a significant trend. In non-DM patients, impaired fasting glucose (β = 0.52, 95% confidence interval [CI] = 0.01-1.03, = 0.046), high HOMA-IR (β = 0.60, 95% CI = 0.12-1.08, = 0.015), and a high PD glucose load (β = 0.58, 95% CI = 0.08-1.08, = 0.023) were independently associated with increased cfPWV. In contrast, none of the glucometabolic factors contributed to differences in cfPWV in DM patients. In conclusion, among PD patients without DM, impaired fasting glucose, insulin resistance, and PD glucose load were closely associated with aortic stiffness.
Topics: Humans; Adult; Middle Aged; Aged; Icodextrin; Insulin Resistance; Pulse Wave Analysis; Vascular Stiffness; Diabetes Mellitus; Peritoneal Dialysis; Glucose; Dialysis Solutions
PubMed: 38069423
DOI: 10.3390/ijms242317094 -
JAMA Dec 2023Early anhydramnios during pregnancy, resulting from fetal bilateral renal agenesis, causes lethal pulmonary hypoplasia in neonates. Restoring amniotic fluid via serial... (Clinical Trial)
Clinical Trial
IMPORTANCE
Early anhydramnios during pregnancy, resulting from fetal bilateral renal agenesis, causes lethal pulmonary hypoplasia in neonates. Restoring amniotic fluid via serial amnioinfusions may promote lung development, enabling survival.
OBJECTIVE
To assess neonatal outcomes of serial amnioinfusions initiated before 26 weeks' gestation to mitigate lethal pulmonary hypoplasia.
DESIGN, SETTING, AND PARTICIPANTS
Prospective, nonrandomized clinical trial conducted at 9 US fetal therapy centers between December 2018 and July 2022. Outcomes are reported for 21 maternal-fetal pairs with confirmed anhydramnios due to isolated fetal bilateral renal agenesis without other identified congenital anomalies.
EXPOSURE
Enrolled participants initiated ultrasound-guided percutaneous amnioinfusions of isotonic fluid before 26 weeks' gestation, with frequency of infusions individualized to maintain normal amniotic fluid levels for gestational age.
MAIN OUTCOMES AND MEASURES
The primary end point was postnatal infant survival to 14 days of life or longer with dialysis access placement.
RESULTS
The trial was stopped early based on an interim analysis of 18 maternal-fetal pairs given concern about neonatal morbidity and mortality beyond the primary end point despite demonstration of the efficacy of the intervention. There were 17 live births (94%), with a median gestational age at delivery of 32 weeks, 4 days (IQR, 32-34 weeks). All participants delivered prior to 37 weeks' gestation. The primary outcome was achieved in 14 (82%) of 17 live-born infants (95% CI, 44%-99%). Factors associated with survival to the primary outcome included a higher number of amnioinfusions (P = .01), gestational age greater than 32 weeks (P = .005), and higher birth weight (P = .03). Only 6 (35%) of the 17 neonates born alive survived to hospital discharge while receiving peritoneal dialysis at a median age of 24 weeks of life (range, 12-32 weeks).
CONCLUSIONS AND RELEVANCE
Serial amnioinfusions mitigated lethal pulmonary hypoplasia but were associated with preterm delivery. The lower rate of survival to discharge highlights the additional mortality burden independent of lung function. Additional long-term data are needed to fully characterize the outcomes in surviving neonates and assess the morbidity and mortality burden.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03101891.
Topics: Female; Humans; Infant; Infant, Newborn; Pregnancy; Fetal Therapies; Gestational Age; Kidney; Kidney Diseases; Prospective Studies; Infusions, Parenteral; Oligohydramnios; Fetal Diseases; Lung Diseases; Isotonic Solutions; Ultrasonography, Interventional; Pregnancy Outcome; Treatment Outcome; Premature Birth
PubMed: 38051327
DOI: 10.1001/jama.2023.21153 -
American Journal of Veterinary Research Feb 2024To compare the influence of fluid on carboplatin elution, and assess the feasibility of ultrafiltration (UF) probe sampling.
OBJECTIVE
To compare the influence of fluid on carboplatin elution, and assess the feasibility of ultrafiltration (UF) probe sampling.
SAMPLE
20 samples of 5 mg carboplatin in 1.0 mL 30% poloxamer 407 eluting in Dulbecco's phosphate-buffered saline (DPBS) or canine plasma and 6 samples of UF probe sampling in 0.01 mg/mL carboplatin in DPBS or plasma.
METHODS
Carboplatin-gel specimens in dialysis tubing (12- to 14-kDa pores) were placed in 100 mL of DPBS or canine plasma (37 °C and 600 rpm stirring) in a nonlidded and lidded experiment. Samples were collected in decreasing frequency for 96 hours. The 0.01-mg/mL carboplatin solutions in DPBS and plasma were sampled 6 times by UF probe (30-kDa pores) or direct aspiration. Platinum was measured using inductively coupled plasma mass spectrometry.
RESULTS
High fluid evaporation was noted in the nonlidded but not the lidded experiment. A burst release was seen in plasma (first 2 hours) and DPBS (first 5 hours) with the highest hourly increase in the first hour in both DPBS (6,040 ppb/h) and plasma (2,612 ppb/h), with no further increase after the first 22 hours. Platinum content in the specimens was higher at 96 hours than the surrounding fluid. Higher platinum concentrations were measured by both direct and UF probe sampling in DPBS than in plasma.
CLINICAL RELEVANCE
Platinum concentrations measured in DPBS were higher than in plasma, but elution patterns were similar. Ultrafiltration probes can be used to sample platinum in vitro and could be used in vivo to measure local unbound Pt tissue concentrations in local chemotherapy delivery.
Topics: Animals; Dogs; Carboplatin; Platinum; Ultrafiltration; Renal Dialysis; Phosphates
PubMed: 38029512
DOI: 10.2460/ajvr.23.09.0205 -
Kidney Medicine Dec 2023Stigma contributes to ineffective treatment for pain among individuals with kidney failure on dialysis, particularly with buprenorphine pain treatment. To address...
RATIONALE & OBJECTIVE
Stigma contributes to ineffective treatment for pain among individuals with kidney failure on dialysis, particularly with buprenorphine pain treatment. To address stigma, we adapted a Design Sprint, an industry-developed structured exercise where an interdisciplinary group works over 5 days to clarify the problem, identify and choose a solution, and build and test a prototype.
STUDY DESIGN
Adapted Design Sprint which clarified the problem to be solved, proposed solutions, and created a blueprint for the selected solution.
SETTINGS & PARTICIPANTS
Five individuals with pain and kidney disease receiving dialysis, 5 physicians (nephrology, palliative care, and addiction medicine) and 4 large dialysis organization leaders recruited for specific expertise or experience. Conducted through online platform (Zoom) and virtual white board (Miro board).
ANALYTICAL APPROACH
Descriptions of the Design Sprint adaptations and processes.
RESULTS
To facilitate patient comfort, a patient-only phase included four 90-minute sessions over 2-weeks, during which patient participants used a mapping process to define the critical problem and sketch out solutions. In a physician-only phase, consisting of two 120-minute sessions, participants accomplished the same tasks. During a combined phase of two 120-minute sessions, patients, physicians, and large dialysis organization representatives vetted and developed solutions from earlier phases, leading to an intervention blueprint. Videoconferencing technology allowed for geographically diverse representation and facilitated participation from patients experiencing medical illness. The electronic whiteboard permitted interactive written contributions and voting on priorities instead of only verbal discussion, which may privilege physician participants. A skilled qualitative researcher facilitated the sessions.
LIMITATIONS
Challenges included the time commitment of the sessions, absences owing to illness or emergencies, and technical difficulties.
CONCLUSIONS
An adapted Design Sprint is a novel method of efficiently and rapidly incorporating multiple stakeholders to develop solutions for clinical challenges in kidney disease.
PLAIN LANGUAGE SUMMARY
Stigma contributes to ineffective treatment for pain among individuals with kidney failure on dialysis, particularly when using buprenorphine, an opioid pain medicine with a lower risk of sedation used to treat addiction. To develop a stigma intervention, we adapted a Design Sprint, an industry-developed structured exercise where an interdisciplinary group works over 5 days to clarify the problem, identify and choose a solution, and build and test a prototype. We conducted 3 sprints with (1) patients alone, (2) physicians alone, and (3) combined patients, physicians, and dialysis organization representatives. This paper describes the adaptations and products of sprints as a method for gathering diverse stakeholder voices to create an intervention blueprint efficiently and rapidly.
PubMed: 38028030
DOI: 10.1016/j.xkme.2023.100729 -
Blood Purification 2024The rapid advancement of artificial intelligence and big data analytics, including descriptive, diagnostic, predictive, and prescriptive analytics, has the potential to...
INTRODUCTION
The rapid advancement of artificial intelligence and big data analytics, including descriptive, diagnostic, predictive, and prescriptive analytics, has the potential to revolutionize many areas of medicine, including nephrology and dialysis. Artificial intelligence and big data analytics can be used to analyze large amounts of patient medical records, including laboratory results and imaging studies, to improve the accuracy of diagnosis, enhance early detection, identify patterns and trends, and personalize treatment plans for patients with kidney disease. Additionally, artificial intelligence and big data analytics can be used to identify patients' treatment who are not receiving adequate care, highlighting care inefficiencies in the dialysis provider, optimizing patient outcomes, reducing healthcare costs, and consequently creating values for all the involved stakeholders.
OBJECTIVES
We present the results of a comprehensive survey aimed at exploring the attitudes of European physicians from eight countries working within a major hemodialysis network (Fresenius Medical Care NephroCare) toward the application of artificial intelligence in clinical practice.
METHODS
An electronic survey on the implementation of artificial intelligence in hemodialysis clinics was distributed to 1,067 physicians. Of the 1,067 individuals invited to participate in the study, 404 (37.9%) professionals agreed to participate in the survey.
RESULTS
The survey showed that a substantial proportion of respondents believe that artificial intelligence has the potential to support physicians in reducing medical malpractice or mistakes.
CONCLUSION
While artificial intelligence's potential benefits are recognized in reducing medical errors and improving decision-making, concerns about treatment plan consistency, personalization, privacy, and the human aspects of patient care persist. Addressing these concerns will be crucial for successfully integrating artificial intelligence solutions in nephrology practice.
Topics: Humans; Artificial Intelligence; Nephrologists; Renal Dialysis; Surveys and Questionnaires; Nephrology
PubMed: 38008072
DOI: 10.1159/000534604 -
Membranes Oct 2023In the last twenty-five years, extensive work has been done on ion exchange membrane bioreactors (IEMB) combining Donnan dialysis and anaerobic reduction to remove trace...
In the last twenty-five years, extensive work has been done on ion exchange membrane bioreactors (IEMB) combining Donnan dialysis and anaerobic reduction to remove trace oxyanions (e.g., perchlorate, nitrate, chlorate, arsenate) from contaminated water sources. Most studies used Donnan dialysis contactors with high recirculation rates on the feed side, so under continuous operation, the effective concentration on the feed side of the membrane is the same as the exit concentration (CSTR mode). We have built, characterized, and modelled a plug flow Donnan dialysis contactor (PFR) that maximizes concentration on the feed side and operated it on feed solutions spiked with perchlorate and nitrate ion using ACS and PCA-100 anion exchange membranes. At identical feed inlet concentrations with the ACS membrane, membrane area loading rates are three-fold greater, and fluxes are more than double in the PFR contactor than in the CSTR contactor. A model based on the nonlinear adsorption of perchlorate in ACS membrane correctly predicted the trace ion concentration as a function of space-time in experiments with ACS. For PCA membrane, a linear flux dependence on feed concentration correctly described trace ion feed concentration as a function of space-time. Anion permeability for PCA-100 was high enough that the overall mass transfer was affected by the film boundary layer resistance. These results provide a basis for efficiently scaling up Donnan dialysis contactors and incorporating them in full-scale IEMB setups.
PubMed: 37999342
DOI: 10.3390/membranes13110856 -
Annals of Biomedical Engineering Mar 2024Inadequate clearance of protein-bound uremic toxins (PBUTs) during dialysis is associated with morbidities in chronic kidney disease patients. The development of...
Inadequate clearance of protein-bound uremic toxins (PBUTs) during dialysis is associated with morbidities in chronic kidney disease patients. The development of high-permeance membranes made from materials such as graphene raises the question whether they could enable the design of dialyzers with improved PBUT clearance. Here, we develop device-level and multi-compartment (body) system-level models that account for PBUT-albumin binding (specifically indoxyl sulfate and p-cresyl sulfate) and diffusive and convective transport of toxins to investigate how the overall membrane permeance (or area) and system parameters including flow rates and ultrafiltration affect PBUT clearance in hemodialysis. Our simulation results indicate that, in contrast to urea clearance, PBUT clearance in current dialyzers is mass-transfer limited: Assuming that the membrane resistance is dominant, raising PBUT permeance from 3 × 10 to 10 m s (or equivalently, 3.3 × increase in membrane area from ~ 2 to ~ 6 m) increases PBUT removal by 48% (from 22 to 33%, i.e., ~ 0.15 to ~ 0.22 g per session), whereas increasing dialysate flow rates or adding adsorptive species have no substantial impact on PBUT removal unless permeance is above ~ 10 m s. Our results guide the future development of membranes, dialyzers, and operational parameters that could enhance PBUT clearance and improve patient outcomes.
Topics: Humans; Uremic Toxins; Uremia; Protein Binding; Renal Dialysis; Toxins, Biological
PubMed: 37993752
DOI: 10.1007/s10439-023-03397-6