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.
調査の概要
研究の種類
介入
入学 (推定)
64
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Punjab Province
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Lahore、Punjab Province、パキスタン、54000
- Services Institute of Medical Sciences, Lahore
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Interdialytic Weight Gain
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Hemoglobin Level
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Zara Ramzan、Services Institute of Medical Sciences, Pakistan
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月23日
一次修了 (推定)
2026年11月22日
研究の完了 (推定)
2026年11月22日
試験登録日
最初に提出
2026年6月10日
QC基準を満たした最初の提出物
2026年6月17日
最初の投稿 (実際)
2026年6月23日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月23日
QC基準を満たした最後の更新が送信されました
2026年6月17日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ServicesIMSP2
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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