A randomized controlled trial of long term effect of BCM guided fluid management in MHD patients (BOCOMO study): rationales and study design

BMC Nephrology

Study Protocol

Li Zuo¹  Li Liu¹  Jianwei Ren²  Jinghong Lei³  Yonghui Mao⁴  Mao Li⁵  Weiming Sun⁶  Moyan Qiu⁷  Yi Sun⁸  Yingchun Ma⁹  Wenjun Liu^1,10  Jinsheng Xu^1,11  Yulan Shen^1,12  Jijun Li^1,13  Shan Lin^1,14  Ping Yuan^1,15  Gang Long^1,16 

[1] Institute of Nephrology, Peking University First Hospital, Beijing, China;Renal Division, Peking University First Hospital, Beijing, China;Renal Department, Aviation General Hospital, Beijing, China;Renal Department, Beijing Aerospace General Hospital, Beijing, China;Renal Department, Beijing Hospital of Ministry of Health, Beijing, China;Renal Department, Beijing Puren Hospital, Beijing, China;Renal Department, Beijing Shijitan Hospital, Beijing, China;Renal Department, Beijing Wangjing Hospital, Beijing, China;Renal Department, Capital University Fuxing Hospital, Beijing, China;Renal Department, China Rehabilitation Research Center, Beijing Boai Hospital, Beijing, China;Renal Department, Guanganmen Hospital, China Academy of Chinese Medical Sciences, Guanganmen, China;Renal Department, Hebei Medical University Forth Hospital, Hebei, China;Renal Department, Miyun Hospital, Beijing, China;Renal Department, PLA General Hospital First Hospital, Beijing, China;Renal Department, Tianjin Medical University General Hospital, Tianjin, China;Renal Department, Tianjin Third Central Hospital, Tianjin, China;Renal Department, Tianjin Union Medicine Center, Tianjin, China;

关键词: Hemodialysis;    Bioimpedance;    Dry weight;    Body composition monitor;    Randomized controlled trial;   

DOI  :  10.1186/1471-2369-13-120

 received in 2012-09-11, accepted in 2012-09-14,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundBioimpedance analysis (BIA) has been reported as helpful in identifying hypervolemia. Observation data showed that hypervolemic maintenance hemodialysis (MHD) patients identified using BIA methods have higher mortality risk. However, it is not known if BIA-guided fluid management can improve MHD patients’ survival. The objectives of the BOCOMO study are to evaluate the outcome of BIA guided fluid management compared with standard care.MethodsThis is a multicenter, prospective, randomized, controlled trial. More than 1300 participants from 16 clinical sites will be included in the study. The enrolment period will last 6 months, and minimum length of follow-up will be 36 months. MHD patients aged between 18 years and 80 years who have been on MHD for at least 3 months and meet eligibility criteria will be invited to participate in the study. Participants will be randomized to BIA arm or control arm in a 1:1 ratio. A portable whole body bioimpedance spectroscopy device (BCM—Fresenius Medical Care D GmbH) will be used for BIA measurement at baseline for both arms of the study. In the BIA arm, additional BCM measurements will be performed every 2 months. The primary intent-to-treat analysis will compare outcomes for a composite endpoint of death, acute myocardial infarction, stroke or incident peripheral arterial occlusive disease between groups. Secondary endpoints will include left ventricular wall thickness, blood pressure, medications, and incidence and length of hospitalization.DiscussionsPrevious results regarding the benefit of strict fluid control are conflicting due to small sample sizes and unstable dry weight estimating methods. To our knowledge this is the first large-scale, multicentre, prospective, randomized controlled trial to assess whether BIS-guided volume management improves outcomes of MHD patients. The endpoints of the BOCOMO study are of utmost importance to health care providers. In order to obtain that aim, the study was designed with very careful important considerations related to the endpoints, sample size, inclusion criteria, exclusion criteria and so on. For example, annual mortality of Beijing MHD patients was around 10%. To reach statistical significance, the sample size will be very large. By using composite endpoint, the sample size becomes reasonable and feasible. Limiting inclusion to patients with urine volume less than 800 ml/day the day before dialysis session will limit confounding due to residual renal function effects on the measured parameters. Patients who had received BIS measurement within 3 months prior to enrolment are excluded as data from such measurements might lead to protocol violation. Although not all patients enrolled will be incident patients, we will record the vintage of dialysis in the multivariable analysis.Trial registrationCurrent Controlled Trials NCT01509937

【 授权许可】

Unknown   
© Liu et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.