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Protocol for a prospective, cluster randomized trial to evaluate routine and deferred dialysis initiation (RADDI) in Chinese population.

ABSTRACT: 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.

SUBMITTER: Zhao X

PROVIDER: S-EPMC6902500 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Protocol for a prospective, cluster randomized trial to evaluate routine and deferred dialysis initiation (RADDI) in Chinese population.

Zhao Xinju X Wang Pei P Wang Lining L Chen Xiaonong X Huang Wen W Mao Yonghui Y Hu Rihong R Cheng Xiaohong X Wang Caili C Wang Li L Zhang Ping P Li Detian D Wang Yuzhu Y Ye Wenling W Chen Yuqing Y Jia Qiang Q Yan Xiaoyan X Zuo Li L

BMC nephrology 20191209 1

<h4>Background</h4>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 li ...[more]

PMID: 31818266

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Project description:BackgroundEarly initiation of chronic dialysis (starting dialysis with higher vs lower kidney function) has risen rapidly in the past 2 decades in Canada and internationally, despite absence of established health benefits and higher costs. In 2014, a Canadian guideline on the timing of dialysis initiation, recommending an intent-to-defer approach, was published.ObjectiveThe objective of this study is to evaluate the efficacy and safety of a knowledge translation intervention to promote the intent-to-defer approach in clinical practice.DesignThis study is a multicenter, 2-arm parallel, cluster randomized trial.SettingThe study involves 55 advanced chronic kidney disease clinics across Canada.PatientsPatients older than 18 years who are managed by nephrologists for more than 3 months, and initiate dialysis in the follow-up period are included in the study.MeasurementsOutcomes will be measured at the patient-level and enumerated within a cluster. Data on characteristics of each dialysis start will be determined by linkages with the Canadian Organ Replacement Register. Primary outcomes include the proportion of patients who start dialysis early with an estimated glomerular filtration rate greater than 10.5 mL/min/1.73 m2 and start dialysis in hospital as inpatients or in an emergency room setting. Secondary outcomes include the rate of change in early dialysis starts; rates of hospitalizations, deaths, and cost of predialysis care (wherever available); quarterly proportion of new starts; and acceptability of the knowledge translation materials.MethodsWe randomized 55 multidisciplinary chronic disease clinics (clusters) in Canada to receive either an active knowledge translation intervention or no intervention for the uptake of the guideline on the timing of dialysis initiation. The active knowledge translation intervention consists of audit and feedback as well as patient- and provider-directed educational tools delivered at a comprehensive in-person medical detailing visit. Control clinics are only exposed to guideline release without active dissemination. We hypothesize that the clinics randomized to the intervention group will have a lower proportion of early dialysis starts.LimitationsLimitations include passive dissemination of the guideline through publication, and lead-time and survivor bias, which favors delayed dialysis initiation.ConclusionsIf successful, this active knowledge translation intervention will reduce early dialysis starts, lead to health and economic benefits, and provide a successful framework for evaluating and disseminating future guidelines.Trial registrationClinicalTrials.gov, NCT02183987.

Project description:BackgroundThe Initiating Dialysis Early and Late (IDEAL) trial, published in 2009, found no clinically measurable benefit with respect to risk of mortality or early complications with early dialysis initiation versus deferred dialysis start. After these findings, guidelines recommended an intent-to-defer approach to dialysis initiation, with the goal of deferring it until clinical symptoms arise.MethodsTo evaluate a four-component knowledge translation intervention aimed at promoting an intent-to-defer strategy for dialysis initiation, we conducted a cluster randomized trial in Canada between October 2014 and November 2015. We randomized 55 clinics, 27 to the intervention group and 28 to the control group. The educational intervention, using knowledge-translation tools, included telephone surveys from a knowledge-translation broker, a 1-year center-specific audit with feedback, delivery of a guidelines package, and an academic detailing visit. Participants included adults who had at least 3 months of predialysis care and who started dialysis in the first year after the intervention. The primary efficacy outcome was the proportion of patients who initiated dialysis early (at eGFR >10.5 ml/min per 1.73 m2). The secondary outcome was the proportion of patients who initiated in the acute inpatient setting.ResultsThe analysis included 3424 patients initiating dialysis in the 1-year follow-up period. Of these, 509 of 1592 (32.0%) in the intervention arm and 605 of 1832 (33.0%) in the control arm started dialysis early. There was no difference in the proportion of individuals initiating dialysis early or in the proportion of individuals initiating dialysis as an acute inpatient.ConclusionsA multifaceted knowledge translation intervention failed to reduce the proportion of early dialysis starts in patients with CKD followed in multidisciplinary clinics.Clinical trial registry name and registration numberClinicalTrials.gov, NCT02183987. Available at: https://clinicaltrials.gov/ct2/show/NCT02183987.

Project description:BACKGROUND:Infant mortality rates are still high in Ethiopia. Breastfeeding is regarded as the simplest and least expensive strategy for reduction of infant mortality rates. Community-based educational and support interventions provided prenatally and postnatally are effective in increasing breastfeeding rates. However, such interventions are not widely implemented in Ethiopia. This study aims to assess the effect of breastfeeding education and support on timely initiation and duration of exclusive breastfeeding. METHODS:A cluster-randomized controlled trial at the community level will be conducted to compare the effect of breastfeeding education and support versus routine care. The intervention will be provided by Women Development Army leaders who are already in the country's health system using a 40-h WHO breastfeeding counseling course, "Infant and Young Child Feeding Counseling: an integrated course" and the "Training of Trainers Manual for Counseling on Maternal, Infant and Young Child Nutrition" in the local language. Culturally appropriate operational packages of information will be developed for them. Using preset criteria at least 432 pregnant women in their third trimester will be recruited from 36 zones. Visits in the intervention arm include two prenatal visits and 8 postnatal visits. Supervisory visits will be conducted monthly to each intervention zone. Data will be entered into Epi-data version 3.1 and analyzed using STATA version 13.0. All analysis will be done by intention to treat analysis. We will fit mixed-effects linear regression models for the continuous outcomes and mixed-effects linear probability models for the binary outcomes with study zone as random intercept to estimate study arm difference (intervention vs. routine education) adjusted for baseline value of the outcome and additional relevant covariates. The protocol was developed in collaboration with the Jimma Zone and Mana district Health office. Ethical clearance was obtained from the Institutional Review Board of University of Oslo and Jimma University. This study is partly funded by NORAD's NORHED programme. DISCUSSION:We expect that the trial will generate findings that can inform breastfeeding policies and practices in Ethiopia. TRIAL REGISTRATION:ClinicalTrials.gov NCT 03030651 January 25, 2017 version 3 dated 16 July 2018.

Project description:BackgroundIn clinical practice, Chinese herbal medicine (CHM) purportedly has beneficial therapeutic effects for chronic kidney disease (CKD), which include delaying disease progression and dialysis initiation. However, there is a lack of high-quality evidence-based results to support this. Therefore, this study aimed to evaluate the efficacy of CHM combined with Western medicine in the treatment of stage 5 CKD.MethodsThis was a prospective nonrandomized controlled study. Stage 5 CKD (nondialysis) patients were recruited form 29 AAA class hospitals across China from July 2014 to April 2019. According to doctors' advice and the patients' wishes, patients were assigned to the CHM group (Western medicine + CHM) and the non-CHM group (Western medicine). Patient demographic data, primary disease, blood pressure, Chinese and Western medical drugs, clinical test results, and time of dialysis initiation were collected during follow-up.ResultsA total of 908 patients were recruited in this study, and 814 patients were finally included for further analysis, including 747 patients in the CHM group and 67 patients in the non-CHM group. 482 patients in the CHM group and 52 patients in the non-CHM group initiated dialysis. The median time of initiating dialysis was 9 (7.90, 10.10) and 3 (0.98,5.02) months in the CHM group and non-CHM group, respectively. The multivariate Cox regression analysis showed that patients in the CHM group had a significantly lower risk of dialysis [adjusted hazard ratio (aHR): 0.38; 95% confidence interval (CI): 0.28, 0.53] compared to those in the non-CHM group. After 1:2 matching, the outcomes of 160 patients were analyzed. The multivariate Cox regression analysis showed that patients in the CHM group had a significantly lower risk of dialysis (aHR: 0.32; 95% CI: 0.21, 0.48) compared to patients in the non-CHM group. Also, the Kaplan-Meier analysis demonstrated that the cumulative incidence of dialysis in the CHM group was significantly lower than that in the non-CHM group (log-rank test, P<0.001) before and after matching.ConclusionsThis study suggest that the combination of CHM and Western medicine could effectively reduce the incidence of dialysis and delay the time of dialysis initiation in stage 5 CKD patients.

Project description:IntroductionMillions of patients are currently suffering from pain and dysfunction caused by osteoarthritis (OA), and billions of dollars have been invested into treatment. Because there is no effective treatment that can reverse the progression of knee OA, it is important to determine the risk factors that may influence the progression. However, although there are many studies that examine risk factors for progression, there are only a few that specifically focus on the impact of each risk factor for predicting progression of knee OA. This study aimed to develop a cohort of patients with primary knee OA in the Beijing area to establish models that identify the influence of each risk factor on the prediction of knee OA progression.Methods and analysisThis is a prospective, multicentre, hospital-based cohort study. The study population comprises 2000 patients with primary knee OA from the Beijing area. The recruitment and baseline visits started in December 2017 and will finish in November 2018. After baseline visits, the patients will be followed for 3 years or until the occurrence of primary outcomes. Demographic variables will be collected during the baseline visit. Influencing factors including occupational exposures, family history and treatment will be collected at baseline and each follow-up visit. The primary outcome measure is a comprehensive index which will be combined with clinical WOMAC score, imaging K-L grade and clinical outcomes. These data will also be collected at baseline and each follow-up visit.Ethics and disseminationThis study protocol has been approved by Peking University Third Hospital Medical Science Research Ethics Committee. All the eligible participants will give written informed consent. The findings will be published in peer-reviewed journals and presented at national or international conferences. Besides, the results will be disseminated to all participants via the social software 'WeChat'.Trial registration numberChiCTR-ROC-17013790; preresults.

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Protocol for a prospective, cluster randomized trial to evaluate routine and deferred dialysis initiation (RADDI) in Chinese population.

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Protocol for a prospective, cluster randomized trial to evaluate routine and deferred dialysis initiation (RADDI) in Chinese population.

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