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首页> 外文期刊>BMC Nephrology >Rationale and design of the balANZ trial: A randomised controlled trial of low GDP, neutral pH versus standard peritoneal dialysis solution for the preservation of residual renal function
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Rationale and design of the balANZ trial: A randomised controlled trial of low GDP, neutral pH versus standard peritoneal dialysis solution for the preservation of residual renal function

机译：balANZ试验的原理和设计：低GDP，中性pH与标准腹膜透析液用于保留残余肾功能的随机对照试验

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Background The main hypothesis of this study is that neutral pH, low glucose degradation product (GDP) peritoneal dialysis (PD) fluid better preserves residual renal function in PD patients over time compared with conventional dialysate. Methods/Design Inclusion criteria are adult PD patients (CAPD or APD) aged 18-81 years whose first dialysis was within 90 days prior to or following enrolment and who have a residual GFR ≥ 5 ml/min/1.73 m2, a urine output ≥ 400 ml/day and an ability to understand the nature and requirements of this trial. Pregnant or lactating patients or individuals with an active infection at the time of enrolment, a contra-indication to PD or participation in any other clinical trial where an intervention is designed to moderate rate of change of residual renal function are excluded. Patients will be randomized 1:1 to receive either neutral pH, low GDP dialysis solution (Balance?) or conventional dialysis solution (Stay.safe?) for a period of 2 years. During this 2 year study period, urinary urea and clearance measurements will be performed at 0, 3, 6, 9, 12, 18 and 24 months. The primary outcome measure will be the slope of residual renal function decline, adjusted for centre and presence of diabetic nephropathy. Secondary outcome measures will include time from initiation of peritoneal dialysis to anuria, peritoneal small solute clearance, peritoneal transport status, peritoneal ultrafiltration, technique survival, patient survival, peritonitis rates and adverse events. A total of 185 patients has been recruited into the trial. Discussion This investigator-initiated study has been designed to provide evidence to help nephrologists determine the optimal dialysis solution for preserving residual renal function in PD patients. Trial Registration Australian New Zealand Clinical Trials Registry Number: ACTRN12606000044527
机译：背景技术这项研究的主要假设是，与传统的透析液相比，中性pH，低葡萄糖降解产物（GDP）腹膜透析（PD）液能更好地保留PD患者随时间推移的残余肾功能。方法/设计纳入标准为年龄18-81岁的成年PD患者（CAPD或APD），其首次透析发生在入选前或入选后90天内，并且残留GFR≥5 ml / min / 1.73 m 2 < / sup>，尿量≥400毫升/天，并且能够理解该试验的性质和要求。孕妇，哺乳期患者或入组时有活动感染的患者，PD的禁忌症或参与旨在干预肾功能残余变化率的任何其他临床试验的临床试验均不包括在内。患者将按1：1的比例随机分配，以接受中性pH值，低GDP透析液（Balance ？）或常规透析液（Stay.safe ？），为期2天年份。在为期2年的研究期内，将在0、3、6、9、12、18和24个月进行尿尿素和清除率的测量。主要结局指标是残余肾功能下降的斜率，并根据糖尿病肾病的中心和存在进行了调整。次要结局指标将包括从腹膜透析开始至无尿的时间，腹膜小溶质清除率，腹膜运输状态，腹膜超滤，技术存活率，患者存活率，腹膜炎发生率和不良事件。该试验共招募了185名患者。讨论由研究者发起的这项研究旨在提供证据，帮助肾脏病医生确定最佳透析解决方案，以保留PD患者的残余肾功能。试验注册澳大利亚新西兰临床试验注册号：ACTRN12606000044527

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