Comparing Hemodiafiltration to Conventional Hemodialysis: Effects on Clinical and Biochemical Parameters
2026年6月17日 更新者：Rameen Masood、Services Institute of Medical Sciences, Pakistan
A Randomized Clinical Trial Comparing Hemodiafiltration to Conventional Hemodialysis: Effects on Clinical and Biochemical Parameters
Chronic kidney disease may progress to end-stage renal disease, a stage in which the kidneys will no longer be able to adequately remove extra fluid and waste products from the body. Many patients with end-stage renal disease will require regular dialysis to survive. Conventional hemodialysis is the most commonly used dialysis technique and will mainly remove waste products through diffusion. Hemodiafiltration is another dialysis technique that will combine diffusion with convection and may help remove a wider range of waste substances from the blood.
This randomized clinical trial will compare hemodiafiltration with conventional hemodialysis in adult patients with end-stage renal disease who are already receiving maintenance dialysis. Eligible participants will be assigned by random allocation to either conventional hemodialysis or hemodiafiltration. Both treatments will be provided as part of routine dialysis care, and no experimental drug will be used.
The main purpose of the study will be to determine whether hemodiafiltration will lead to better fluid control compared with conventional hemodialysis. Fluid control will be assessed by measuring the average weight gained between dialysis sessions over a four-week period. The study will also compare selected blood test parameters between the two groups after one month, including hemoglobin, C-reactive protein, serum albumin, total cholesterol, serum calcium, serum phosphate, and intact parathyroid hormone.
研究概览
研究类型
介入性
注册 (估计的)
64
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Punjab Province
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Lahore、Punjab Province、巴基斯坦、54000
- Services Institute of Medical Sciences, Lahore
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Adult patients aged 18-70 years.
- Both male or female.
- End-stage kidney disease as per operational definition.
- On a stable dialysis prescription for at least 3 months, with thrice-weekly sessions (or unit-standard schedule) and stable dry weight assessment.
- Clinically stable over the preceding 4 weeks, with no hospitalization or acute intercurrent illness.
Exclusion Criteria:
- Cardiovascular instability: recurrent intradialytic hypotension (≥30% of sessions in the prior month requiring saline or early termination), uncontrolled hypertension (SBP >180 mmHg or DBP >110 mmHg despite therapy), recent acute coronary syndrome, stroke, or decompensated heart failure within 3 months.
- Advanced hepatic disease (decompensated cirrhosis or refractory ascites), active systemic infection, chronic inflammatory disease flare, or active malignancy under treatment likely to confound fluid status or survival.
- Recent blood transfusion within the preceding 4 weeks, or active bleeding, as these may distort hemoglobin and inflammatory indices.
- Advanced chronic liver disease, nephrotic-range protein loss, or other conditions likely to substantially alter serum albumin independent of dialysis modality.
- Parathyroidectomy history or current use of intravenous calcimimetics initiation/change within the preceding 4 weeks, if expected to markedly alter intact parathyroid hormone.
- Adherence concerns: documented inability to follow fluid/salt advice or to attend scheduled treatments during the screening period; anticipated surgery or hospitalization within the study window.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Group A Conventional Hemodialysis
Participants assigned to this group will receive conventional bicarbonate hemodialysis as per routine departmental dialysis protocol.
Each dialysis session will last at least four hours and will be delivered twice or thrice weekly according to unit practice.
Other dialysis prescription parameters will be kept as consistent as clinically feasible during follow-up.
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Conventional bicarbonate hemodialysis will be performed as part of routine maintenance dialysis care.
This technique will primarily remove solutes through diffusion across a semipermeable dialysis membrane, with ultrafiltration for fluid removal.
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实验性的：Group B Hemodiafiltration
Participants assigned to this group will receive hemodiafiltration as per routine departmental dialysis protocol.
Each dialysis session will last at least four hours and will be delivered twice or thrice weekly according to unit practice.
Other dialysis prescription parameters will be kept as consistent as clinically feasible during follow-up.
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Hemodiafiltration will be performed as part of routine maintenance dialysis care.
This technique will combine diffusive and convective solute removal, using replacement fluid according to departmental protocol.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Interdialytic Weight Gain
大体时间：Baseline and one month after randomization.
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Mean interdialytic weight gain will be assessed in kilograms.
For each dialysis session, interdialytic weight gain will be calculated as the pre-dialysis weight of the current session minus the post-dialysis weight of the immediately preceding session.
Body weight will be measured using a calibrated digital scale in the dialysis unit.
Session-level interdialytic weight gain values will be recorded throughout the follow-up period, and the mean value for each participant will be calculated by dividing the total interdialytic weight gain by the number of attended dialysis sessions.
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Baseline and one month after randomization.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Hemoglobin Level
大体时间：Baseline and one month after randomization.
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Hemoglobin level will be measured in g/dL using routine hospital laboratory testing.
The mean hemoglobin level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
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Baseline and one month after randomization.
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Mean C-Reactive Protein Level
大体时间：Baseline and one month after randomization.
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C-reactive protein level will be measured in mg/L using routine hospital laboratory testing.
The mean C-reactive protein level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
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Baseline and one month after randomization.
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Mean Serum Albumin Level
大体时间：Baseline and one month after randomization.
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Serum albumin level will be measured in g/dL using routine hospital laboratory testing.
The mean serum albumin level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
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Baseline and one month after randomization.
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Mean Total Cholesterol Level
大体时间：Baseline and one month after randomization.
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Total cholesterol level will be measured in mg/dL using routine hospital laboratory testing.
The mean total cholesterol level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
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Baseline and one month after randomization.
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Mean Serum Calcium Level
大体时间：Baseline and one month after randomization.
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Total serum calcium level will be measured in mg/dL using routine hospital laboratory testing.
The mean serum calcium level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
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Baseline and one month after randomization.
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Mean Serum Phosphate Level
大体时间：Baseline and one month after randomization.
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Serum phosphate level will be measured in mg/dL using routine hospital laboratory testing.
The mean serum phosphate level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
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Baseline and one month after randomization.
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Mean Intact Parathyroid Hormone Level
大体时间：Baseline and one month after randomization.
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Intact parathyroid hormone level will be measured in pg/mL using routine hospital laboratory testing.
The mean intact parathyroid hormone level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
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Baseline and one month after randomization.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Zara Ramzan、Services Institute of Medical Sciences, Pakistan
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月23日
初级完成 (估计的)
2026年11月22日
研究完成 (估计的)
2026年11月22日
研究注册日期
首次提交
2026年6月10日
首先提交符合 QC 标准的
2026年6月17日
首次发布 (实际的)
2026年6月23日
研究记录更新
最后更新发布 (实际的)
2026年6月23日
上次提交的符合 QC 标准的更新
2026年6月17日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ServicesIMSP2
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