Pentoxifylline and Systemic Inflammation in Hemodialysis Patients
Randomized, Double-Blinded, Controlled Clinical Trial of the Effect Pentoxifylline vs Placebo on the Serum Concentrations of TNF-a, IL-6 and CRP of Patients in Hemodialysis
調査の概要
詳細な説明
Patients were randomly selected from the total HD patients of our hospital. Once included, patients were randomly allocated (by a computer-generated randomization list) to a study or control group. Over a period of 4 months, patients of the study group received one PTX tablet (400 mg) orally once a day (at dinner time), whereas controls received one starch identical tablet on the same schedule.
All patients had three HD sessions per week, with the same kind of single-use dialysis membrane and dialysate. Monthly visits were scheduled for clinical and biochemical evaluations. A blood sample was taken at baseline and every month for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids, and electrolytes (measured by usual methods). In serum samples at 0, 2 and 4 months, TNF-α and IL-6 concentrations were measured by ELISA using high sensitivity kits (Amersham Pharmacia Biotech, Buckinghamshire, UK). Additionally, in the same serum samples, CRP concentrations were measured by nephelometry using high sensitivity kits (Dade Behring, Marburg, Germany) in a Nephelometry Analyzer II (Dade Behring, Marburg, Germany). All laboratory measurements, including inflammation markers, were performed in the Central Laboratory (Hospital de Especialidades, CMNO), by the same personnel blinded to patient's details.
Treatment compliance was recorded by counting tablets left in the container at the end of each monthly visit.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Jalisco
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Guadalajara、Jalisco、メキシコ、44320
- Hospital de Especialidades, CMNO, IMSS
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age ≥18 years,
- ≥2 months on HD,
- arteriovenous fistula as vascular access, and
- endorsement of informed consent.
Exclusion Criteria:
- inflammatory cause of ESRD,
- liver disease, cancer, AIDS,
- any infectious disease 2 months before the study,
- failed kidney graft,
- hypersensitivity to PTX or other methylxanthines,
- hemorrhage/clotting disorders,
- risk for worsening pre-existing cardiac arrhythmias or arterial hypotension,
- treatment with antibiotics, non-steroidal anti-inflammatory drugs, steroids, immunosuppressives, statins or PTX 3 months previous to the study
研究計画
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：プラセボ
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Over a period of 4 months, patients of the control group received one starch tablet orally once a day (at dinner time)
他の名前：
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実験的：pentoxifylline
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Over a period of 4 months, patients of the study group received one PTX tablet (400 mg) orally once a day (at dinner time)
他の名前：
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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 |
時間枠 |
|---|---|
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serum levels of TNF-a, IL-6 and CRP
時間枠：4 months
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4 months
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協力者と研究者
捜査官
- スタディチェア：Alfonso M. M Cueto-Manzano, MD, MSc, PhD、Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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