Feasibility of Twice-Weekly Hemodialysis: Contingency Planning for COVID-19.
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ABSTRACT:
SUBMITTER: Clark DA
PROVIDER: S-EPMC7863757 | biostudies-literature | 2021 Mar-Apr
REPOSITORIES: biostudies-literature
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Feasibility of Twice-Weekly Hemodialysis: Contingency Planning for COVID-19.
Clark David A DA West Kenneth A KA Tennankore Karthik K KK
Kidney medicine 20210205 2
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Project description:BackgroundPhysical and emotional symptoms are prevalent in patients with kidney-dysfunction requiring dialysis (KDRD) and the rigors of thrice-weekly hemodialysis (HD) may contribute to deteriorated health-related quality of life. Less intensive HD schedules might be associated with lower symptom and/or emotional burden.MethodsThe TWOPLUS Pilot study was an individually-randomized trial conducted at 14 dialysis units, with the primary goal to assess feasibility and safety. Patients with incident KDRD and residual kidney function were assigned to incremental HD start (twice-weekly HD for 6 weeks followed by thrice-weekly HD) vs conventional HD (thrice-weekly HD). In exploratory analyses, we compared the two treatment groups with respect to three patient-reported outcomes measures. We analyzed the change from baseline in the score on Dialysis Symptom Index (DSI, range 0-150), Generalized Anxiety Disorder-7 (GAD-7, range 0-21), and Patient Health Questionnaire-9 (PHQ-9, range 0-27) at 6 (n = 20 in each treatment group) and 12 weeks (n = 21); with lower scores denoting lower symptom burden. Analyses were adjusted for age, race, gender, baseline urine volume, diabetes mellitus, and malignancy. Participants' views on the intervention were sought using a Patient Feedback Questionnaire (n = 14 in incremental and n = 15 in conventional group).ResultsThe change from baseline to week 6 in estimated mean score (standard error; P value) in the incremental and conventional group was - 9.7 (4.8; P = 0.05) and - 13.8 (5.0; P = 0.009) for DSI; - 1.9 (1.0; P = 0.07) and - 1.5 (1.4; P = 0.31) for GAD-7; and - 2.5 (1.1; P = 0.03) and - 3.5 (1.5; P = 0.02) for PHQ-9, respectively. Corresponding changes from week 6 to week 12 were - 3.1 (3.2; P = 0.34) and - 2.4 (5.5; P = 0.67) in DSI score; 0.5 (0.6; P = 0.46) and 0.1 (0.6; P = 0.87) in GAD-7 score; and - 0.3 (0.6; P = 0.70) and - 0.5 (0.6; P = 0.47) in PHQ-9 score, respectively. Majority of respondents felt their healthcare was not jeopardized and expressed their motivation for study participation was to help advance the care of patients with KDRD.ConclusionsThis study suggests a possible mitigating effect of twice-weekly HD start on symptoms of anxiety and depression at transition from pre-dialysis to KDRD. Larger clinical trials are required to rigorously test clinically-matched incrementally-prescribed HD across diverse organizations and patient populations.Trial registrationRegistered at ClinicalTrials.gov with study identifier NCT03740048, registration date 14/11/2018.
| S-EPMC9513956 | biostudies-literature
Project description:Residual kidney function (RKF) contributes to improved survival in hemodialysis (HD) patients. However, it is not clear whether RKF allows a comparable survival rate in patients undergoing twice-weekly HD compared with thrice-weekly HD.We enrolled 685 patients from a prospective multicenter observational cohort. RKF and HD adequacy was monitored regularly over 3-year follow-up. Patients with RKF were divided into groups undergoing twice-weekly HD (n = 113) or thrice-weekly HD (n = 137). Patients without RKF undergoing thrice-weekly HD (n = 435) were included as controls. Fluid balance and dialysis-associated characteristics were followed and clinical outcomes evaluated using all-cause mortality and cardiovascular events (CVE).In patients with RKF, baseline and follow-up RKF were significantly higher in patients undergoing twice-weekly HD than in those undergoing thrice-weekly HD. Total Kt/V urea (dialysis plus residual renal) in patients with RKF undergoing twice-weekly HD was greater than or equal to those in patients with or without RKF undergoing thrice-weekly HD. Compared with patients with RKF undergoing thrice-weekly HD, patients with RKF undergoing twice-weekly HD had no fluid excess, but their normalized protein catabolic rate became lower since 24-month follow up. In multivariable analyses, patients with RKF undergoing twice-weekly HD had a noninferior risk of mortality (hazard ratio [HR], 0.83; 95% confidence interval [95% CI], 0.34-2.01, P = 0.68) and of CVE (HR, 0.60; 95% CI, 0.28-1.29, P = 0.19) compared with patients without RKF undergoing thrice-weekly HD. However, this group showed an independent association with a greater risk of mortality compared with patients with RKF undergoing thrice-weekly HD (HR, 4.20; 95% CI, 1.02-17.32, P = 0.04).In conclusion, patients with RKF undergoing twice-weekly HD had an increased risk of mortality compared with those undergoing thrice-weekly HD. Decisions about twice-weekly HD should consider not only RKF, but also other risk factors such as normalized protein catabolic rate.
| S-EPMC4998622 | biostudies-literature
Project description:IntroductionIn China, a quarter of patients are undergoing 2-times weekly hemodialysis. Using data from the China Dialysis Outcomes and Practice Patterns Study (DOPPS), we tested the hypothesis that whereas survival and hospitalizations would be similar in the presence of residual kidney function (RKF), patients without RKF would fare worse on 2-times weekly hemodialysis.MethodsIn our cohort derived from 15 units randomly selected from each of 3 major cities (total N = 45), we generated a propensity score for the probability of dialysis frequency assignment, estimated a survival function by propensity score quintiles, and averaged stratum-specific survival functions to generate mean survival time. We used the proportional rates model to assess hospitalizations. We stratified all analyses by RKF, as reported by patients (urine output <1 vs. ≥1 cup/day).ResultsAmong 1265 patients, 123 and 133 were undergoing 2-times weekly hemodialysis with and without evidence of RKF. Over 2.5 years, adjusted mean survival times were similar for 2- versus 3-times weekly dialysis groups: 2.20 versus 2.23 and 2.20 versus 2.15 for patients with and without RKF (P = 0.65). Hazard ratios for hospitalization rates were similar for 2- versus 3-times weekly groups, with (1.15, 95% confidence interval = 0.66-2.00) and without (1.10, 95% confidence interval 0.68-1.79]) RKF. The normalized protein catabolic rate was lower and intradialytic weight gain was not substantially higher in the 2- versus 3-times weekly dialysis group, suggesting greater restriction of dietary sodium and protein.ConclusionIn our study of patients in China's major cities, we could not detect differences in survival and hospitalization for those undergoing 2- versus 3-times weekly dialysis, regardless of RKF. Our findings indicate the need for pragmatic studies regarding less frequent dialysis with associated nutritional management.
| S-EPMC6035134 | biostudies-literature
Project description:Background Most patients on hemodialysis are treated thrice weekly even if they have residual kidney function, in part because uncertainty remains as to how residual function should be valued and incorporated into the dialysis prescription. Recent guidelines, however, have increased the weight assigned to residual function and thus reduced the treatment time required when it is present. Increasing the weight assigned to residual function may be justified by knowledge that the native kidney performs functions not replicated by dialysis, including solute removal by secretion. This study tested whether plasma concentrations of secreted solutes are as well controlled in patients with residual function on twice weekly hemodialysis as in anuric patients on thrice weekly hemodialysis.Methods We measured the plasma concentration and residual clearance, dialytic clearance, and removal rates for urea and the secreted solutes hippurate, phenylacetylglutamine, indoxyl sulfate, and p-cresol sulfate in nine patients on twice weekly hemodialysis and nine patients on thrice weekly hemodialysis.Results Compared with anuric patients on thrice weekly dialysis with the same standard Kt/Vurea, patients on twice weekly hemodialysis had lower hippurate and phenylacetylglutamine concentrations and similar indoxyl sulfate and p-cresol sulfate concentrations. Mathematical modeling revealed that residual secretory function accounted for the observed pattern of solute concentrations.Conclusions Plasma concentrations of secreted solutes can be well controlled by twice weekly hemodialysis in patients with residual kidney function. This result supports further study of residual kidney function value and the inclusion of this function in dialysis adequacy measures.
| S-EPMC6050930 | biostudies-literature
Project description:ObjectiveMarkers of better nutritional status including both higher levels of serum albumin (as a measure of visceral proteins) and creatinine (as a measure of the muscle mass) are associated with lower mortality in conventional (thrice weekly) hemodialysis patients. However, data for these associations in twice-weekly hemodialysis patients, in whom less frequent hemodialysis may confound nutritional predictors, are lacking.Design and subjectsWe identified 1,113 twice-weekly and matched 4,448 thrice-weekly hemodialysis patients from a large national dialysis cohort of incident hemodialysis patients over 5 years (2007-2011). Mortality risk, adjusted for potential confounders, was examined across two-by-two combinations of serum creatinine (<6 vs. ≥6 mg/dL) and albumin (<3.5 g/dL vs. ≥3.5 g/dL) for each treatment frequency yielding a total of 8 groups.ResultsPatients were aged 70 ± 14 years and included 48% women and 55% diabetics. Using the thrice-weekly hemodialysis patients with creatinine ≥ 6 mg/dL and albumin ≥ 3.5 g/dL as reference, patients with creatinine <6 mg/dL and albumin <3.5 g/dL had a 1.8-fold higher risk of mortality (hazard ratio: 1.75, 95% confidence interval: 1.33-2.30) in twice-weekly and 2.2-fold increased risk of mortality (hazard ratio: 2.21, 95% confidence interval: 1.81-2.70) in thrice-weekly hemodialysis patients, respectively in fully adjusted models adjusted for demographics, comorbidities, and markers of malnutrition and inflammation. A test for interaction showed that there was no significant difference in albumin creatinine mortality associations between twice-weekly and thrice-weekly hemodialysis patients (P-for-interaction = .7667).ConclusionsSurrogate markers of higher visceral protein and muscle mass combined may confer greatest survival in both twice-weekly and thrice-weekly hemodialysis patients.
| S-EPMC5326741 | biostudies-literature
Project description:Cumulative evidence indicates it may be worthwhile revisiting the twice-weekly hemodialysis (HD) regimen as a valid option for individualized or incremental treatments for selected patients with end-stage renal disease. In this article, we will review the current evidences on the potential pros and cons of twice-weekly HD compared to thrice-weekly HD including China's experience in the practice of twice-weekly HD. A prudent patient selection and close dialysis adequacy monitoring might be necessary for this medical treatment choice. More randomized prospective controlled studies for the critical evaluation of twice-weekly dialysis are encouraged.
| S-EPMC5545085 | biostudies-literature
Project description:Coronavirus disease (COVID-19) outbreaks on board cruise ships early in the pandemic highlighted gaps worldwide in public health emergency contingency plans (PHECPs) for responding to unknown threats. To restart cruise operations in 2021 and respond to potential COVID-19 outbreaks, a major tourist-based Greek island port (Port A) developed a COVID-19 PHECP. We assessed plan effectiveness by reviewing epidemiological data and monitoring outcomes, followed by an intra-action review (IAR) analyzing three event responses. From May to December 2021, 118 calls from 23 cruise ships with 119,930 passengers were recorded, with 29 COVID-19 cases in 11 cruises on board 7 ships. No outbreak was recorded during the study period. Strengths of the introduced PHECP included commitment of senior management; a core multi-disciplinary team of local authorities/ship agents involved in design and execution; interoperability agreements for port and ships' PHECPs; cruise industry commitment to compliance; and pre-existing scenarios considering capacity needs. Central government coordination for preparedness planning at local ports is essential for successful responses. Monitoring local and country level response capacities is critical to inform planning, risk assessment, and decision-making. Immediately recording ports' response actions provides the basis to capture lessons and improve contingency plans. To facilitate communication and common response protocols between European and non-European ports, IARs should be conducted between countries.
| S-EPMC9603745 | biostudies-literature
Project description:A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial (the TWICE study) conducted in Japanese primary osteoporosis patients with a high risk of fractures demonstrated that a 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen of teriparatide, while also improving safety.IntroductionWhile a 56.5-μg once-weekly regimen of teriparatide has high efficacy for osteoporosis, treatment continuation rates are low, with one of the major causes being adverse drug reactions such as nausea or vomiting. The TWICE study was therefore conducted to investigate whether a twice-weekly regimen with 28.2-μg teriparatide can provide comparable efficacy to the 56.5-μg once-weekly regimen while improving safety.MethodsA 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial was conducted in Japan. Patients with primary osteoporosis aged ≥ 65 years at high risk of fractures (n = 553) were randomly allocated to the 28.2-μg twice-weekly group (n = 277) or the 56.5-μg once-weekly group (n = 276). The primary endpoint was the percentage change in lumbar spine (L2-L4) bone mineral density (BMD) at final follow-up.ResultsThe percentage changes in lumbar spine (L2-L4) BMD at final follow-up in the 28.2-μg twice-weekly and 56.5-μg once-weekly groups were 7.3% and 5.9%, respectively; the difference (95% confidence interval [CI]) in percentage change was 1.3% (0.400-2.283%). Since the lower limit of the 95% CI was above the pre-specified non-inferiority margin (- 1.6%), non-inferiority of the 28.2-μg twice-weekly group was demonstrated. Adverse drug reactions were significantly less frequent in the 28.2-μg twice-weekly group (39.7% vs 56.2%; p < 0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-μg twice-weekly group.ConclusionsA 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen while improving safety.Clinical trial registrationJapicCTI-163477 .
| S-EPMC6811384 | biostudies-literature
Project description:RationaleRecent studies have demonstrated that intermittent administration of rifamycin-based regimens results in higher rates of tuberculosis relapse and treatment failure compared with daily therapy. Twice-weekly treatment with rifampin, isoniazid, and pyrazinamide may be improved by increasing Mycobacterium tuberculosis exposure to rifamycin by substituting rifapentine for rifampin.MethodsTo test this hypothesis, we compared the activities of standard daily and twice-weekly rifampin plus isoniazid-based regimens to those of twice-weekly rifapentine plus isoniazid- or moxifloxacin-containing regimens in the murine model of tuberculosis. Relapse rates were assessed after 4, 5, and 6 mo of treatment to assess stable cure. Single- and multiple-dose pharmacokinetics of rifampin and rifapentine were also determined.ResultsAfter 2 mo of treatment, twice-weekly therapy with rifapentine (15 or 20 mg/kg), moxifloxacin, and pyrazinamide was significantly more active than standard daily or twice-weekly therapy with rifampin, isoniazid, and pyrazinamide. Stable cure was achieved after 4 mo of twice-weekly rifapentine plus isoniazid- or moxifloxacin-containing therapy, but only after 6 mo of standard daily therapy. Twice-weekly rifapentine (15 mg/kg) displayed more favorable pharmacodynamics than did daily rifampin (10 mg/kg).ConclusionsBy virtue of the enhanced rifamycin exposure, twice-weekly regimens containing rifapentine (15 or 20 mg/kg) may permit shortening the current treatment duration by 2 mo. Such regimens warrant clinical investigation.
| S-EPMC1862756 | biostudies-literature
Project description:Rationale & objectiveMajor depressive disorder (MDD) is common among hemodialysis patients, but treatment can add to their pill burden and may be limited by nonadherence. We sought to investigate the value of directly observed, once-weekly fluoxetine dosing in MDD.Study designFeasibility trial of adult hemodialysis patients with untreated MDD. The diagnosis of MDD was determined using the Mini International Neuropsychiatric Interview.Setting & participants16 patients at 15 hemodialysis facilities in Northeast Ohio.InterventionPatients were initially prescribed 20 mg of fluoxetine once daily for 2 weeks to assess their tolerance. The patients took this daily fluoxetine unobserved at home. They were then transitioned to 90 mg of fluoxetine once weekly for 10 weeks. The patients took this weekly fluoxetine during hemodialysis treatment and were observed by the study staff. The dose was increased to 180 mg once weekly among patients with an inadequate response based on the judgment of the prescribing clinician.OutcomesMini International Neuropsychiatric Interview diagnosis of MDD at the end of the trial and changes in the Patient Health Questionnaire (PHQ-9) scores over 12 weeks.ResultsOne patient withdrew from active treatment after 2 daily doses of 20 mg of fluoxetine because of side effects of stomach cramping, vomiting, dizziness, and lightheadedness but completed the baseline and final assessments. The remaining 15 patients received all scheduled weekly fluoxetine doses during the trial. At 12 weeks, 14 of 16 patients (87.5%) no longer met the criteria for MDD (P < 0.001). Among all participants, the mean PHQ-9 scores decreased from 11.3 to 6.6 (P = 0.002).LimitationsSmall sample size, modestly elevated baseline PHQ-9 scores, no comparison group, and short treatment duration.ConclusionsDirectly observed, once-weekly fluoxetine may be an effective and well-tolerated treatment option for hemodialysis patients. Future research should investigate longer-term health outcomes of weekly fluoxetine in this population and explore the feasibility of implementing this depression treatment model in routine clinical practice.Trial registrationThis trial was registered at clinicaltrials.gov as NCT03390933.
| S-EPMC8978139 | biostudies-literature