A Pilot Randomized Trial of Intradialysis Yoga for Patients With End-Stage Kidney Disease.
Ontology highlight
ABSTRACT:
SUBMITTER: Herron A
PROVIDER: S-EPMC9939353 | biostudies-literature | 2023 Feb
REPOSITORIES: biostudies-literature
Publications
A Pilot Randomized Trial of Intradialysis Yoga for Patients With End-Stage Kidney Disease.
Herron Ann A Cavanaugh Kerri L KL Umeukeje Ebele M EM Ikizler T Alp TA Birdee Gurjeet G
Kidney international reports 20221119 2
Similar Datasets
Project description:ImportanceSystematic differences between patients included in randomized clinical trials (RCTs) and the general patient population may influence the generalizability of RCT findings. Comprehensive national registries of patients with end-stage kidney disease who are undergoing dialysis provide a unique opportunity to compare trial and real-world patient cohorts.ObjectiveTo determine if participants in large, multicenter dialysis trials were similar to the general population undergoing dialysis in terms of age, comorbidities, and mortality rate.Data sourcesMEDLINE, PubMed, and the Cochrane Central Register of Controlled Trials were systematically searched on January 6, 2017, for studies published from January 1, 2007, to December 31, 2016. Data sources were published manuscripts, supplementary material, and trial registration information. Data on the general population undergoing dialysis were derived from the US Renal Data System (USRDS). Data were analyzed from March 17 to July 22, 2018.Study selectionRandomized clinical trials enrolling only participants undergoing dialysis for end-stage kidney disease with 100 or more adult participants from 2 or more sites.Data extraction and synthesisAbstract screening and data extraction were performed independently by 2 researchers. Data were pooled using a random-effects model.Main outcomes and measuresThe primary outcome was difference in mean age between the RCT and USRDS populations. Secondary outcomes included differences in mortality rate and comorbidities.ResultsThe search identified 186 RCTs, enrolling 79 104 participants. Compared with the 2011 USRDS population, RCT participants were younger (mean age, 58.9 years; 95% CI, 58.3-59.5 years vs 61.2 years; P < .001), more likely to be male (58.9%; 95% CI, 57.6%-60.1% vs 55.7%; P < .001), and have coronary artery disease (26.9%; 95% CI, 22.2%-31.7% vs 17.7%; P < .001) and less likely to have diabetes (40.2%; 95% CI, 36.7%-43.6% vs 44.2%; P = .03) or heart failure (19.6%; 95% CI, 15.1%-24.0% vs 29.8%; P < .001). The mortality rate per 100 patient-years during trial participation was less than half that of the USRDS population (8.9; 95% CI, 7.8-10.0 vs 18.6; P < .001). The differences in age, mortality, and coronary artery disease remained when studies recruiting only from the United States were considered. Diabetes was more common in RCT participants from the United States than in the registry population.Conclusions and relevanceParticipants in large, multicenter RCTs of patients with end-stage kidney disease undergoing dialysis are younger, have a different pattern of comorbidities, and have a lower mortality rate than the general population of patients undergoing dialysis. This finding has implications for the generalization of trial results to the broader patient population and for future trial design.
| S-EPMC6618769 | biostudies-literature
Project description:BACKGROUND AND OBJECTIVES:The US Centers for Medicare and Medicaid Services have mandated reducing early (30-day) hospital readmissions to improve patient care and reduce costs. Patients with ESKD have elevated early readmission rates, due in part to complex medical regimens but also cognitive impairment, literacy difficulties, low social support, and mood problems. We developed a brief family consultation intervention to address these risk factors and tested whether it would reduce early readmissions. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:One hundred twenty hospitalized adults with ESKD (mean age=58 years; 50% men; 86% black, 14% white) were recruited from an urban, inpatient nephrology unit. Patients were randomized to the family consultation (n=60) or treatment-as-usual control (n=60) condition. Family consultations, conducted before discharge at bedside or via telephone, educated the family about the patient's cognitive and behavioral risk factors for readmission, particularly cognitive impairment, and how to compensate for them. Blinded medical record reviews were conducted 30 days later to determine readmission status (primary outcome) and any hospital return visit (readmission, emergency department, or observation; secondary outcome). Logistic regressions tested the effects of the consultation versus control on these outcomes. RESULTS:Primary analyses were intent-to-treat. The risk of a 30-day readmission after family consultation (n=12, 20%) was 0.54 compared with treatment-as-usual controls (n=19, 32%), although this effect was not statistically significant (odds ratio, 0.54; 95% confidence interval, 0.23 to 1.24; P=0.15). A similar magnitude, nonsignificant result was observed for any 30-day hospital return visit: family consultation (n=19, 32%) versus controls (n=28, 47%; odds ratio, 0.53; 95% confidence interval, 0.25 to 1.1; P=0.09). Per protocol analyses (excluding three patients who did not receive the assigned consultation) revealed similar results. CONCLUSIONS:A brief consultation with family members about the patient's cognitive and psychosocial risk factors had no significant effect on 30-day hospital readmission in patients with ESKD.
| S-EPMC5989676 | biostudies-literature
Project description:IntroductionThis double-blind, randomized controlled trial compared the safety and efficacy of subcutaneous epoetin alfa-epbx, an epoetin alfa biosimilar, with the reference product, epoetin alfa, in hemodialysis patients with end-stage kidney disease (ESKD) and anemia who were receiving epoetin alfa maintenance treatment.MethodsEligible patients (n = 320) were randomized (1:1) to subcutaneous epoetin alfa-epbx or epoetin alfa in a titration phase; patients who demonstrated stable subcutaneous dosing (n = 246) were re-randomized to receive subcutaneous epoetin alfa-epbx or epoetin alfa 1 to 3 times per week in a 16-week maintenance phase. Co-primary endpoints were least-squares mean difference between treatments in mean weekly hemoglobin concentration and mean weekly epoetin dose per kilogram body weight (BW) during the last 4 weeks of treatment in the maintenance phase.ResultsThe least-squares mean difference (95% confidence interval [CI]) between treatments in weekly hemoglobin was 0.04 g/dl (-0.17 to 0.24 g/dl) and weekly epoetin dose/kg BW was -2.34 U/kg per week (-14.51 to 9.82 U/kg per week). The 95% CIs were contained within the prespecified equivalence margins of ±0.5 g/dl (weekly hemoglobin) and ±45 U/kg per week (weekly epoetin dose/kg BW). In the epoetin alfa-epbx and epoetin alfa groups, respectively, 4.0% and 4.1% of patients required blood transfusions, 69.7% and 70.5% reported adverse events, 18.9% and 27.0% reported serious adverse events, and 3 and 2 deaths were reported. Five patients were confirmed positive for anti-recombinant human erythropoietin antibody, 2 of whom tested positive at baseline. All patients tested negative for neutralizing antibodies.ConclusionsThis comparative clinical trial demonstrated equivalence in efficacy and similar safety of subcutaneously administered epoetin alfa-epbx to epoetin alfa.
| S-EPMC6734106 | biostudies-literature
Project description:Purpose of reviewThis review evaluates current recommendations for pain management in chronic kidney disease (CKD) and end-stage kidney disease (ESKD) with a specific focus on evidence for opioid analgesia, including the partial agonist, buprenorphine.Recent findingsRecent evidence supports the use of physical activity and other nonpharmacologic therapies, either alone or with pharmacological therapies, for pain management. Nonopioid analgesics, including acetaminophen, topical analgesics, gabapentinoids, serotonin-norepinephrine reuptake inhibitors, and TCA may be considered based on pain cause and type, with careful dose considerations in kidney disease. NSAIDs may be used in CKD and ESKD for short durations with careful monitoring. Opioid use should be minimized and reserved for patients who have failed other therapies. Opioids have been associated with increased adverse events in this population, and thus should be used cautiously after risk/benefit discussion with the patient. Opioids that are safer to use in kidney disease include oxycodone, hydromorphone, fentanyl, methadone, and buprenorphine. Buprenorphine appears to be a promising and safer option due to its partial agonism at the mu opioid receptor.SummaryPain is poorly managed in patients with kidney disease. Nonpharmacological and nonopioid analgesics should be first-line approaches for pain management. Opioid use should be minimized with careful monitoring and dose adjustment.
| S-EPMC7753951 | biostudies-literature
Project description:This study aimed to investigate alterations in a multilayer network combining structural and functional layers in patients with end-stage kidney disease (ESKD) compared with healthy controls. In all, 38 ESKD patients and 43 healthy participants were prospectively enrolled. They exhibited normal brain magnetic resonance imaging (MRI) without any structural lesions. All participants, both ESRD patients and healthy controls, underwent T1-weighted imaging, diffusion tensor imaging (DTI), and resting-state functional MRI (rs-fMRI) using the same three-tesla MRI scanner. A structural connectivity matrix was generated using the DTI and DSI programs, and a functional connectivity matrix was created using the rs-fMRI and SPM programs in the CONN toolbox. Multilayer network analysis was conducted based on structural and functional connectivity matrices using BRAPH. Significant differences were observed at the global level in the multilayer network between patients with ESKD and healthy controls. The weighted multiplex participation was lower in patients with ESKD than in healthy controls (0.6454 vs. 0.7212, adjusted p = 0.049). However, other multilayer network measures did not differ. The weighted multiplex participation in the right subcentral gyrus, right opercular part of the inferior frontal gyrus, right occipitotemporal medial lingual gyrus, and right postcentral gyrus in patients with ESKD was lower than that in the corresponding regions in healthy controls (0.6704 vs. 0.8562, 0.8593 vs. 0.9388, 0.7778 vs. 0.8849, and 0.6825 vs. 0.8112; adjusted p < 0.05, respectively).This study demonstrated that the multilayer network combining structural and functional layers in patients with ESKD was different from that in healthy controls. The specific differences in weighted multiplex participation suggest potential disruptions in the integrated communication between different brain regions in these patients.
| S-EPMC11685722 | biostudies-literature
Project description:IntroductionCystic expansion damaging the parenchyma is thought to lead to end-stage kidney disease (ESKD) in autosomal dominant polycystic kidney disease (ADPKD). Here we characterized genotypic and phenotypic attributes of ADPKD at time of ESKD.MethodsThis is a retrospective cross-sectional study of patients with ADPKD with ESKD evaluated at Mayo Clinic with available abdominal computed tomography (CT) or magnetic resonance imaging (MRI). Kidney volumes were measured (total kidney volume adjusted for height [HtTKV]), Mayo Image Class (MIC) calculated, ADPKD genotype determined, and clinical and laboratory features obtained from medical records.ResultsDifferences in HtTKV at ESKD were associated with patient age and sex; older patients and women had smaller HtTKV at ESKD. HtTKV at ESKD was observed to be 12.3% smaller with each decade of age (P < 0.01); but significant only in women (17.8%, P < 0.01; men 6.9%, P = 0.06). Patients with onset of ESKD at <47, 47-61, or >61 years had different characteristics, with a shift from youngest to oldest in male to female enrichment, MIC from 1D/1E to 1B/1C, likely fully penetrant PKD1 mutations from 95% to 42%, and presence of macrovascular disease from 8% to 40%. Macrovascular disease was associated with smaller kidneys in female patients.ConclusionHtTKV at ESKD was smaller with advancing age in patients with ADPKD, particularly in women. These novel findings provide insight into possible underlying mechanisms leading to ESKD, which differ between younger and older individuals. Cystic growth is the predominant mechanism in younger patients with ESKD, whereas aging-related factors, including vascular disease, becomes potentially important as patients age.
| S-EPMC7938061 | biostudies-literature
Project description:Background/aimsDecision-making in elderly patients considering dialysis is highly complex. With the increasing number of elderly with end-stage kidney disease (ESKD), it may be important to assess geriatric impairments in this population. The aim of the Geriatric assessment in OLder patients starting Dialysis (GOLD) study was to assess the prevalence of geriatric impairments and frailty in the elderly ESKD population by means of a geriatric assessment (GA), which is a comprehensive tool for overall health assessment.MethodsThis study included 285 patients ≥65 years: 196 patients at the time of dialysis initiation and 89 patients who chose maximal conservative management (MCM). The GA assessed cognition, mood, nutritional status, (instrumental) activities of daily living (ADL), mobility, comorbidity burden, quality of life and overall frailty.ResultsThe mean age of the participants was 78 years and 36% were women. Of the incident dialysis patients, 77% started haemodialysis and 23% started peritoneal dialysis. Geriatric impairments were highly prevalent in both dialysis and MCM patients. Most frequently impaired geriatric domains in the dialysis group were functional performance (ADL 29%, instrumental ADL (iADL) 79%), cognition (67%) and comorbidity (41%). According to the GA, 77% in the dialysis group and 88% in the MCM group had 2 or more geriatric impairments. In the MCM group, functional impairment (ADL 45%, iADL 85%) was highly prevalent.ConclusionsGeriatric impairments are highly prevalent in the elderly ESKD population. Since impairments can be missed when not searched for in regular (pre)dialysis care, the first step of improving nephrologic care is awareness of the extensiveness of geriatric impairment.
| S-EPMC6381867 | biostudies-literature
Project description:End-stage kidney disease (ESKD) patients are at increased cardiovascular risk. Vitamin D deficiency is associated with depressed heart rate variability (HRV), a risk factor depicting poor cardiac autonomic tone and risk of cardiovascular death. Vitamin D deficiency and depressed HRV are highly prevalent in the ESKD population. We aimed to determine the effects of oral vitamin D supplementation on HRV ((low frequency (LF) to high frequency (HF) spectral ratio (LF:HF)) in ESKD patients on hemodialysis. Fifty-six subjects with ESKD requiring hemodialysis were recruited from January 2013-March 2015 and randomized 1:1 to either conventional (0.25 mcg alfacalcidol plus placebo 3×/week) or intensive (0.25 mcg alfacalcidol 3×/week plus 50,000 international units (IU) ergocalciferol 1×/week) vitamin D for six weeks. The primary outcome was the change in LF:HF. There was no difference in LF:HF from baseline to six weeks for either vitamin D treatment (conventional: p = 0.9 vs. baseline; intensive: p = 0.07 vs. baseline). However, participants who remained vitamin D-deficient (25-hydroxyvitamin D < 20 ng/mL) after treatment demonstrated an increase in LF:HF (conventional: n = 13, ∆LF:HF: 0.20 ± 0.06, p < 0.001 vs. insufficient and sufficient vitamin D groups; intensive: n = 8: ∆LF:HF: 0.15 ± 0.06, p < 0.001 vs. sufficient vitamin D group). Overall, six weeks of conventional or intensive vitamin D only augmented LF:HF in ESKD subjects who remained vitamin D-deficient after treatment. Our findings potentially suggest that while activated vitamin D, with or without additional nutritional vitamin D, does not appear to improve cardiac autonomic tone in hemodialysis patients with insufficient or sufficient baseline vitamin D levels, supplementation in patients with severe vitamin D deficiency may improve cardiac autonomic tone in this higher risk sub-population of ESKD. ClinicalTrials.gov, NCT01774812.
| S-EPMC5083996 | biostudies-literature
Project description:ImportanceHome dialysis rates for end-stage kidney disease (ESKD) treatment are substantially lower in the US than in other high-income countries, yet there is limited knowledge on how to increase these rates.ObjectiveTo report results from the first year of a nationwide randomized clinical trial that provides financial incentives to ESKD facilities and managing clinicians to increase home dialysis rates.Design, setting, and participantsResults were analyzed from the first year of the End-Stage Renal Disease Treatment Choice (ETC) model, a multiyear, mandatory-participation randomized clinical trial designed and implemented by the US Center for Medicare & Medicaid Innovation. Data were reported on Medicare patients with ESKD 66 years or older who initiated treatment with dialysis in 2021, with data collection through December 31, 2021; the study included all eligible ESKD facilities and managing clinicians. Eligible hospital referral regions (HRRs) were randomly assigned to the ETC (91 HRRs) or a control group (211 HRRs).InterventionsThe ESKD facilities and managing clinicians received financial incentives for home dialysis use.Main outcomes and measuresThe primary outcome was the percentage of patients with ESKD who received any home dialysis during the first 90 days of treatment. Secondary outcomes included other measures of home dialysis and patient volume and characteristics.ResultsAmong the 302 HRRs eligible for randomization, 18 621 eligible patients initiated dialysis treatment during the study period (mean [SD] age, 74.8 [1.05] years; 7856 women [42.1%]; 10 765 men [57.9%]; 859 Asian [5.2%], 3280 [17.7%] Black, 730 [4.3%] Hispanic, 239 North American Native, and 12 394 managing clinicians. The mean (SD) share of patients with any home dialysis during the first 90 days was 20.6% (7.8%) in the control group and was 0.12 percentage points higher (95% CI, -1.42 to 1.65 percentage points; P = .88) in the ETC group, a statistically nonsignificant difference. None of the secondary outcomes differed significantly between groups.Conclusions and relevanceThe trial results found that in the first year of the US Center for Medicare & Medicaid Innovation-designed ETC model, HRRs assigned to the model did not have statistically significantly different rates in home dialysis compared with control HRRs. This raises questions about the efficacy of the financial incentives provided, although further evaluation is needed, as the size of these incentives will increase in subsequent years.Trial registrationClinicalTrials.gov Identifier: NCT05005572.
| S-EPMC9547325 | biostudies-literature
Project description:Chronic kidney disease (CKD) is a serious public health problem characterized by progressive kidney function loss leading to end-stage renal disease (ESRD) that demands dialysis or kidney transplantation. Early detection can prevent or delay progression to ESRD. The study aimed to gain new insights into the perturbed biochemical reactions and to identify novel distinct biomarkers between ESRD and CKD. Serum samples of 32 patients with ESRD (n = 13) and CKD (n = 19) were analyzed using chemical isotope labeling liquid chromatography-mass spectrometry metabolomics approach. A total of 193 metabolites were significantly altered in ESRD compared to CKD and were mainly involved in aminoacyl-tRNA biosynthesis, branched-chain amino acid (BCAA) biosynthesis, taurine metabolism, and tryptophan metabolism. Three kynurenine derivatives, namely, 2-aminobenzoic acid, xanthurenic acid, and hydroxypicolinic acid were upregulated in ESRD compared to CKD due to the significant decrease in glomerular filtration rate with the progression of CKD to ESRD. N-Hydroxy-isoleucine, 2-aminobenzoic acid, and picolinic acid yielded AUC > 0.99 when analyzed using Receiver Operating Characteristic (ROC) analysis. Our findings suggest that inhibiting the kynurenine pathway might be a promising target to delay CKD progression and that metabolites with high discriminative ability might serve as potential prognostic biomarkers to monitor the progression of CKD to ESRD or used in combination with current markers to indicate the status of kidney damage better.
| S-EPMC10105740 | biostudies-literature