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学科主题: 临床医学
题名:
A randomized controlled trial of long term effect of BCM guided fluid management in MHD patients (BOCOMO study): rationales and study design
作者: Liu, Li; Long, Gang; Ren, Jianwei; Li, Jijun3; Xu, Jinsheng2; Lei, Jinghong4; Li, Mao5; Qiu, Moyan6; Yuan, Ping7; Sun, Weiming8; Lin, Shan9; Liu, Wenjun10; Sun, Yi11; Ma, Yingchun12; Mao, Yonghui13; Shen, Yulan14; Zuo, Li1
关键词: Hemodialysis ; Bioimpedance ; Dry weight ; Body composition monitor ; Randomized controlled trial
刊名: BMC NEPHROLOGY
发表日期: 2012-09-25
DOI: 10.1186/1471-2369-13-120
卷: 13
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Urology & Nephrology
研究领域[WOS]: Urology & Nephrology
关键词[WOS]: X-RAY ABSORPTIOMETRY ; HEMODIALYSIS-ASSOCIATED HYPOTENSION ; BODY-COMPOSITION ; DRY-WEIGHT ; BIOIMPEDANCE ; MORTALITY ; DIALYSIS ; ULTRAFILTRATION ; ANTHROPOMETRY ; SURVIVAL
英文摘要:

Background: Bioimpedance 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.

Methods: This 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.

Discussions: Previous 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.

语种: 英语
项目资助者: Fresenius Medical Care Shanghai Co. LTD
WOS记录号: WOS:000310906400001
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/54876
Appears in Collections:北京大学第一临床医学院_肾脏内科_期刊论文

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作者单位: 1.Capital Univ, Renal Dept, Fuxing Hosp, Beijing, Peoples R China
2.Minist Hlth, Renal Dept, Beijing Hosp, Beijing, Peoples R China
3.Miyun Hosp, Renal Dept, Beijing, Peoples R China
4.Tianjin Third Cent Hosp, Renal Dept, Tianjin, Peoples R China
5.Beijing Shijitan Hosp, Renal Dept, Beijing, Peoples R China
6.Beijing Aerosp Gen Hosp, Renal Dept, Beijing, Peoples R China
7.Beijing Puren Hosp, Renal Dept, Beijing, Peoples R China
8.Beijing Wangjing Hosp, Renal Dept, Beijing, Peoples R China
9.Peking Univ, Renal Div, Hosp 1, Inst Nephrol, Beijing 100034, Peoples R China
10.Hebei Med Univ, Renal Dept, Hosp 4, Shijiazhuang, Hebei, Peoples R China
11.Peoples Liberat Army Gen Hosp, Renal Dept, Hosp 1, Beijing, Peoples R China
12.Tianjin Med Univ, Renal Dept, Gen Hosp, Tianjin, Peoples R China
13.China Acad Chinese Med Sci, Renal Dept, Guanganmen Hosp, Guanganmen, Peoples R China
14.Beijing Boai Hosp, Renal Dept, China Rehabil Res Ctr, Beijing, Peoples R China

Recommended Citation:
Liu, Li,Long, Gang,Ren, Jianwei,et al. A randomized controlled trial of long term effect of BCM guided fluid management in MHD patients (BOCOMO study): rationales and study design[J]. BMC NEPHROLOGY,2012,13.
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