Dialysis timing may be deferred toward very late initiation: An observational study.
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ABSTRACT:
SUBMITTER: Chang YL
PROVIDER: S-EPMC7219782 | biostudies-literature | 2020
REPOSITORIES: biostudies-literature
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Dialysis timing may be deferred toward very late initiation: An observational study.
Chang Yun-Lun YL Wang Jie-Sian JS Yeh Hung-Chieh HC Ting I-Wen IW Huang Han-Chun HC Chiang Hsiu-Yin HY Hsiao Chiung-Tzu CT Chu Pei-Lun PL Kuo Chin-Chi CC
PloS one 20200513 5
The optimal timing to initiate dialysis among patients with an estimated glomerular filtration rate (eGFR) of <5 mL/min/1.73 m2 is unknown. We hypothesized that dialysis initiation time can be deferred in this population even with high uremic burden. A case-crossover study with case (0-30 days before dialysis initiation [DI]) and control (90-120 days before DI) periods was conducted in 1,079 hemodialysis patients aged 18-90 years at China Medical University Hospital between 2006 and 2015. The ur ...[more]
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Project description:ImportancePublished in 2010, the Initiating Dialysis Early and Late (IDEAL) randomized clinical trial, which randomized patients with an estimated glomerular filtration rate (GFR) between 10 and 15 mL/min/1.73 m2 to planned initiation of dialysis with an estimated GFR between 10 and 14 mL/min/1.73 m2 (early start) or an estimated GFR between 5 and 7 mL/min/1.73 m2 (late start), concluded that early initiation was not associated with improved survival or clinical outcomes.ObjectiveTo assess the association between the IDEAL trial results and the proportion of early dialysis starts over time.Design, setting, and participantsThis interrupted time series analysis used data from the Canadian Organ Replacement Register to study adult (≥18 years of age) patients with incident chronic dialysis between January 1, 2006, and December 31, 2015, in Canada, which has a universal health care system. Patients from the province of Quebec were excluded because its privacy laws preclude submission of deidentified data without first-person consent. The patients included in the study (n = 28 468) had at least 90 days of nephrologist care before starting dialysis and a recorded estimated GFR at dialysis initiation. Data analyses were performed from November 2016 to January 2019.Main outcomes and measuresThe primary outcome was the proportion of early dialysis starts (estimated GFR >10.5 mL/min/1.73 m2), and the secondary outcomes included the proportions of acute inpatient dialysis starts, patients who started dialysis using a home modality, and patients receiving hemodialysis who started with an arteriovenous access. Measures included the trend prior to the IDEAL trial publication, the change in this trend after publication, and the immediate consequence of publication.ResultsThe final cohort comprised 28 468 patients, of whom 17 342 (60.9%) were male and the mean (SD) age was 64.8 (14.6) years. Before the IDEAL trial, a statistically significant increasing trend was observed in the monthly proportion of early dialysis starts (adjusted rate ratio, 1.002; 95% CI, 1.001-1.004; P = .004). After the IDEAL trial, an immediate decrease was observed in the proportion of early dialysis starts (rate ratio, 0.874; 95% CI, 0.818-0.933; P < .001), along with a statistically significant change in trend between the pretrial and posttrial periods (rate ratio, 0.994; 95% CI, 0.992-0.996; P < .001). No statistically significant differences were found in acute inpatient dialysis initiations, the proportion of patients receiving home dialysis as the initial modality, or the proportion of arteriovenous access creation at hemodialysis initiation after the IDEAL trial publication.Conclusions and relevanceThe publication of the IDEAL trial appeared to be associated with an immediate and meaningful change in the timing of dialysis initiation in Canada.
| S-EPMC6547160 | biostudies-literature
Project description:BackgroundPhysicians' perceptions and opinions may influence when to initiate dialysis.ObjectiveTo examine providers' perspectives and opinions regarding the timing of dialysis initiation.DesignOnline survey.SettingCommunity and academic dialysis practices in Canada.ParticipantsA nationally-representative sample of dialysis providers.Measurements and methodsDialysis providers opinions assessing reasons to initiate dialysis at low or high eGFR. Responses were obtained using a 9-point Likert scale. Early dialysis was defined as initiation of dialysis in an individual with an eGFR greater than or equal to 10.5 ml/min/m(2). A detailed survey was emailed to all members of the Canadian Society of Nephrology (CSN) in February 2013. The survey was designed and pre-tested to evaluate duration and ease of administration.ResultsOne hundred and forty one (25% response rate) physicians participated in the survey. The majority were from urban, academic centres and practiced in regionally administered renal programs. Very few respondents had a formal policy regarding the timing of dialysis initiation or formally reviewed new dialysis starts (N = 4, 3.1%). The majority of respondents were either neutral or disagreed that late compared to early dialysis initiation improved outcomes (85-88%), had a negative impact on quality of life (89%), worsened AVF or PD use (84-90%), led to sicker patients (83%) or was cost effective (61%). Fifty-seven percent of respondents felt uremic symptoms occurred earlier in patients with advancing age or co-morbid illness. Half (51.8%) of the respondents felt there was an absolute eGFR at which they would initiate dialysis in an asymptomatic patient. The majority of respondents would initiate dialysis for classic indications for dialysis, such as volume overload (90.1%) and cachexia (83.7%) however a significant number chose other factors that may lead them to early dialysis initiation including avoiding an emergency (28.4%), patient preference (21.3%) and non-compliance (8.5%).Limitations25% response rate.ConclusionsAlthough the majority of nephrologists in Canada who responded followed evidence-based practice regarding the timing of dialysis initiation, knowledge gaps and areas of clinical uncertainty exist. The implementation and evaluation of formal policies and knowledge translation activities may limit potentially unnecessary early dialysis initiation.
| S-EPMC4346295 | biostudies-literature
Project description:Background and objectivesThere is a trend in the United States to maintenance dialysis initiation at higher levels of estimated GFR. This study aimed to determine whether provider characteristics and pre-ESRD nephrology care and vascular access are independently associated with higher estimated GFR at initiation.Design, setting, participants, & measurementsThis retrospective cohort study used US Renal Data System data for patients who initiated dialysis in 2006 (n=83,621) and American Medical Association Physician Master File data for provider characteristics. Patient characteristics and estimated GFR were defined, and providers at dialysis initiation were identified. Earlier dialysis initiation was defined as initiation at estimated GFR>10 ml/min per 1.73 m(2). Nephrologist density per 100 ESRD patients was calculated by Health Service Area in 2006. Associations between provider characteristics and estimated GFR were determined using logistic regression and linear regression models, accounting for provider clustering.ResultsOf the cohort, 47.8% of patients initiated dialysis at estimated GFR>10 ml/min per 1.73 m(2), and 16.2% of patients initiated dialysis at estimated GFR?15 ml/min per 1.73 m(2). Predialysis nephrologist care for 0-12 months was associated with greater odds of earlier initiation compared with no care. Patients initiating with an arteriovenous fistula or graft were more likely to initiate earlier than patients initiating with a catheter. Provider sex was not associated with timing of dialysis initiation as measured by estimated GFR. Care by providers who graduated from nondomestic medical schools was associated with greater odds of earlier initiation. Greater provider experience was associated with lower likelihood of earlier initiation.ConclusionThis study supports the hypothesis that provider factors are associated with timing of dialysis initiation in the United States.
| S-EPMC3913233 | biostudies-literature
Project description:IntroductionInitiating dialysis in acute kidney injury (AKI) in an intensive care unit (ICU) remains a subjective clinical decision. We examined factors and practice patterns that influence early initiation of dialysis in ICU patients with acute kidney injury.MethodsAn online survey presented nephrologists (international) with three case scenarios with unstated predicted mortality rates of < 10%, 10 - 30% and > 30%. For each case the respondents were asked 4 questions about influences on the decision whether or not to initiate dialysis within 24 hours: Q1, likelihood of initiating dialysis; Q2, threshold of BUN levels (< 50, 50 - 75, 76 - 100, > 100 mg/dl) considered relevant to this decision; Q3, magnitude of creatinine elevation (two to three-fold increase; greater than threefold increase; absolute level > 5 mg/dl regardless of change) considered relevant; Q4, a rank order of the influence of five parameters (BUN level, change of creatinine from baseline, oxygen saturation, potassium level, and urine output), 1 being the most influential and 5 being the least influential.ResultsOne hundred seventy-two nephrologists (73% in practice for > 5 years; 70% from the U.S.A.) responded to the survey. The proportion of subjects likely to initiate early dialysis increased (76% to 94%), as did the predicted mortality (p < 0.001). The proportion of subjects considering early dialysis at a BUN level ? 75 increased from 17% to 30 to 40% as the predicted mortality of the cases increased (p < 0.0001). The proportion of subjects choosing absolute creatinine level to be more influential than relative increment, went from 60% to 54% to 43% as predicted mortality increased (p < 0.0001). Rank-order analysis indicated that influence of oxygen saturation and potassium level on dialysis decision showed a significant change with severity of illness, but BUN level and creatinine elevation remained less influential, and did not change with severity.ConclusionsSeverely ill patients were more likely to be subjected to early dialysis initiation, but its utility is not clear. Rank-order analysis indicates dialysis initiation is still influenced by "imminent" indications rather than a "proactive" decision based on the severity of AKI or azotemia.
| S-EPMC3672626 | biostudies-literature
Project description:Automated reporting of eGFR by laboratories has been widely implemented during the last decade. Over this same period, a steady increase in eGFR at dialysis initiation has been reported. This study examined trends in eGFR at dialysis initiation over time among incident dialysis patient populations before and after eGFR reporting. All patients who initiated dialysis between January of 2001 and December of 2010 in four Canadian provinces that implemented province-wide automated eGFR reporting and had an eGFR measure at dialysis initiation were included in the study (n=22,208). The primary outcome was change over time in eGFR among patients at dialysis initiation. An interrupted time series and adjusted multilevel regression models were used to determine the differences in eGFR at dialysis initiation before and after reporting. We observed a linear increase in the mean eGFR at dialysis initiation from 9.1 to 10.8 ml/min per m(2) during the study period. There was no change in the trajectory of the eGFR at dialysis initiation before or after eGFR reporting in crude or adjusted models accounting for case mix and facility characteristics. These findings were consistent among age and sex strata and when the proportions of patients with an eGFR≥10.5 or ≥12 ml/min per m(2) were examined. In conclusion, automated laboratory-based eGFR reporting did not influence eGFR at dialysis initiation among incident dialysis patient populations. Concerns that widespread eGFR reporting leads to earlier dialysis initiation are not supported by this study.
| S-EPMC4147980 | biostudies-literature
Project description:Whether secular trends in eGFR at dialysis initiation reflect changes in clinical presentation over time is unknown. We reviewed the medical records of a random sample of patients who initiated maintenance dialysis in the Department of Veterans Affairs (VA) in fiscal years 2000-2009 (n=1691) to characterize trends in clinical presentation in relation to eGFR at initiation. Between fiscal years 2000-2004 and 2005-2009, mean eGFR at initiation increased from 9.8±5.8 to 11.0±5.5 ml/min per 1.73 m(2) (P<0.001), the percentage of patients with an eGFR of 10-15 ml/min per 1.73 m(2) increased from 23.4% to 29.9% (P=0.002), and the percentage of patients with an eGFR>15 ml/min per 1.73 m(2) increased from 12.1% to 16.3% (P=0.01). The proportion of patients who were acutely ill at the time of initiation and the proportion of patients for whom the decision to initiate dialysis was based only on level of kidney function did not change over time. Frequencies of documented clinical signs and/or symptoms were similar during both time periods. The adjusted odds of initiating dialysis at an eGFR of 10-15 or >15 ml/min per 1.73 m(2) (versus <10 ml/min per 1.73 m(2)) during the later versus earlier time period were 1.43 (95% confidence interval [95% CI], 1.13 to 1.81) and 1.46 (95% CI, 1.09 to 1.97), respectively. In conclusion, trends in eGFR at dialysis initiation at VA medical centers do not seem to reflect changes in the clinical context in which dialysis is initiated.
| S-EPMC4520153 | biostudies-literature
Project description:BACKGROUND:The timing of when to initiate dialysis for progressive chronic kidney disease (CKD) patients has not been well established. There has been a strong trend for early dialysis initiation for these patients over the past decades. However, the perceived survival advantage of early dialysis has been questioned by a series of recent observational studies. The only randomized controlled trial (RCT) research on this issue found the all-cause mortality, comorbidities, and quality of life showed no difference between early and late dialysis starters. To better understand optimal timing for dialysis initiation, our research will evaluate the efficacy and safety of deferred dialysis initiation in a large Chinese population. METHODS:The trial adopts a multicenter, cluster randomized, single-blind (outcomes assessor), and endpoint-driven design. Eligible participants are 18-80 years old, in stable CKD stages 4-5 (eGFR > 7 ml/min /1.73 m2), and with good heart function (NYHA grade I or II). Participants will be randomized into a routine or deferred dialysis group. The reference eGFR at initiating dialysis for asymptomatic patients is 7 ml/min /1.73 m2 (routine dialysis group) and 5 ml/min/1.73 m2 or less (deferred dialysis group) in each group. The primary endpoint will be the difference of all-cause mortality and acute nonfatal cerebro-cardiovascular events between the two groups. The secondary outcomes include hospitalization rate and other safety indices. The primary and secondary outcomes will be analyzed by appropriate statistical methods. DISCUSSION:This study protocol represents a large, cluster randomized study evaluating deferred and routine dialysis intervention for an advanced CKD population. The reference eGFR to initiate dialysis for both treatment groups is targeted at less than 7 ml/min/1.73m2. With this design, we aim to eliminate lead-time and survivor bias and avoid selection bias and confounding factors. We acknowledge that the study has limitations. Even so, given the low-targeted eGFR values of both arms, this study still has potential economic, health, and scientific implications. This research is unique in that such a low targeted eGFR value has never been studied in a clinical trial. TRIAL REGISTRATION:The trial has been approved by ClinicalTrials.gov (Trial registration ID NCT02423655). The date of registration was April 22, 2015.
| S-EPMC6902500 | biostudies-literature
Project description:BackgroundThe optimal timing to start androgen deprivation therapy (ADT) in prostate cancer patients with rising prostate-specific antigen (PSA) as the only sign of relapse is unknown.MethodsWe identified men with prostate cancer in the Cancer of the Prostate Strategic Urologic Research Endeavour (CaPSURE) study who would have been eligible (⩽ cT3aN0M0, primary radical prostatectomy or radiotherapy, PSA relapse as the only evidence of recurrence) for a randomised trial comparing 'immediate' versus 'deferred' ADT initiation. We emulated such trial by assigning patients to the 'immediate' strategy if they initiated ADT within 3 months of PSA relapse and to the 'deferred' strategy if they initiated ADT when they presented with metastasis, symptoms or a short PSA doubling time. We censored patients when they deviated from the assigned strategy and adjusted for this censoring via inverse probability weighting.ResultsOf 2096 eligible patients (median age 69, interquartile range 63-75 years), 88% were white, 35% had a Gleason score ⩾ 7, 69% were treated with radical prostatectomy and 31% received radiotherapy only as primary treatment. The mean time from primary treatment to PSA relapse was 37.4 (standard deviation [SD] 34.2) months. Mean follow-up from primary treatment was 91.4 (SD 48.4) months. The adjusted mortality hazard ratio for immediate versus deferred ADT was 0.91 (95% confidence interval (CI), 0.52-1.60), which would be translated into a similar 5-year survival (difference between groups: -2.0% (95% CI: -10.0 to 5.9%).ConclusionOur analysis suggests that prostate cancer patients undergoing immediate ADT initiation within three months after PSA-only relapse had similar survival to those who deferred ADT initiation within 3 months after clinical progression.
| S-EPMC4402138 | biostudies-literature
Project description:Previous observational studies examining outcomes associated with the timing of dialysis therapy initiation in the United States have often been limited by lead time and survivor bias.Retrospective cohort study comparing the effectiveness of early versus later (conventional) dialysis therapy initiation in advanced chronic kidney disease (CKD). The analysis used inverse probability weighting to account for an individual's contribution to different exposure groups over time in a pooled logistic regression model. Patients contributed risk to both exposure categories (early and later initiation) until there was a clear treatment strategy (ie, dialysis therapy was initiated early or estimated glomerular filtration rate [eGFR] decreased to <10mL/min/1.73m(2)).Patients with CKD who had at least one face-to-face outpatient encounter with a Cleveland Clinic health care provider as of January 1, 2005, and at least 3 eGFRs in the range of 20-30mL/min/1.73m(2) measured at least 180 days apart.Timing of dialysis therapy initiation as determined using model-based interpolation of eGFR trajectories over time. Timing was defined as early (interpolated eGFR at dialysis therapy initiation?10mL/min/1.73m(2)) or later (eGFR < 10mL/min/1.73m(2)) and was time-varying.Death from any cause occurring from the time that eGFR was equal to 20mL/min/1.73m(2) through September 15, 2009.The study population consisted of 652 patients meeting inclusion criteria. Most (71.3%) of the study population did not initiate dialysis therapy during follow-up. Patients who did not initiate dialysis therapy (n=465) were older, more likely to be white, and had more favorable laboratory profiles than those who started dialysis therapy. Overall, 146 initiated dialysis early and 80 had eGFRs decrease to <10mL/min/1.73m(2). Many participants (n=426) were censored prior to attaining a clear treatment strategy and were considered undeclared. There was no statistically significant survival difference for the early compared with later initiation strategy (OR, 0.85; 95% CI, 0.65-1.11).Interpolated eGFR, moderate sample size, and likely unmeasured confounders.In patients with advanced CKD, timing of dialysis therapy initiation was not associated with mortality when accounting for lead time bias and survivor bias.
| S-EPMC4117406 | biostudies-literature
Project description:ObjectiveTo identify the optimal estimated glomerular filtration rate (eGFR) at which to initiate dialysis in people with advanced chronic kidney disease.DesignNationwide observational cohort study.SettingNational Swedish Renal Registry of patients referred to nephrologists.ParticipantsPatients had a baseline eGFR between 10 and 20 mL/min/1.73 m2 and were included between 1 January 2007 and 31 December 2016, with follow-up until 1 June 2017.Main outcome measuresThe strict design criteria of a clinical trial were mimicked by using the cloning, censoring, and weighting method to eliminate immortal time bias, lead time bias, and survivor bias. A dynamic marginal structural model was used to estimate adjusted hazard ratios and absolute risks for five year all cause mortality and major adverse cardiovascular events (composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) for 15 dialysis initiation strategies with eGFR values between 4 and 19 mL/min/1.73 m2 in increments of 1 mL/min/1.73 m2. An eGFR between 6 and 7 mL/min/1.73 m2 (eGFR6-7) was taken as the reference.ResultsAmong 10 290 incident patients with advanced chronic kidney disease (median age 73 years; 3739 (36%) women; median eGFR 16.8 mL/min/1.73 m2), 3822 started dialysis, 4160 died, and 2446 had a major adverse cardiovascular event. A parabolic relation was observed for mortality, with the lowest risk for eGFR15-16. Compared with dialysis initiation at eGFR6-7, initiation at eGFR15-16 was associated with a 5.1% (95% confidence interval 2.5% to 6.9%) lower absolute five year mortality risk and 2.9% (0.2% to 5.5%) lower risk of a major adverse cardiovascular event, corresponding to hazard ratios of 0.89 (95% confidence interval 0.87 to 0.92) and 0.94 (0.91 to 0.98), respectively. This 5.1% absolute risk difference corresponded to a mean postponement of death of 1.6 months over five years of follow-up. However, dialysis would need to be started four years earlier. When emulating the intended strategies of the Initiating Dialysis Early and Late (IDEAL) trial (eGFR10-14 v eGFR5-7) and the achieved eGFRs in IDEAL (eGFR7-10 v eGFR5-7), hazard ratios for all cause mortality were 0.96 (0.94 to 0.99) and 0.97 (0.94 to 1.00), respectively, which are congruent with the findings of the randomised IDEAL trial.ConclusionsVery early initiation of dialysis was associated with a modest reduction in mortality and cardiovascular events. For most patients, such a reduction may not outweigh the burden of a substantially longer period spent on dialysis.
| S-EPMC8628190 | biostudies-literature