Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney
Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney Transplantation in Vivo
Renal Insufficiency is a priority disease in health system, which may require renal replacement therapy based on renal transplantation, which is considered as therapy of choice. During the procedure of renal transplantation, the graft could be damaged by ischemia-reperfusion which generates complications in its function.
Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized, which could be beneficial in renal transplantation.
調査の概要
詳細な説明
Objective: Evaluate anti-inflammatory effect of atorvastatin on renal graft in living donor transplantation.
Material and methods: Controlled, double-blind clinical trial with posterior following for 12 months. Composed by 48 patients, randomized manner, realized at the Transplant Department of Western Medical Center, Mexican Institute of Social Security. Universe was patients accepted as kidney donors. Patients were randomized in two groups (study or control) the intervention was implemented 4 weeks before kidney transplant. Previous surgical procedure, in a blood sample, C-Reactive Protein (C-RP) and laboratory control were measured. During surgical procedure, a biopsy was obtained to measure IL-6 and tumoral necrosis factor alpha by immunohistochemistry. 24 hours after surgical procedure, 3 and 12 months of following, kidney function, complications and graft survival were registered. During surgical procedure, 3 months and 12 months of following, biopsies were obtain to performed histopathological analysis of scale of Banff
The statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages.
研究の種類
入学 (実際)
段階
- フェーズ 3
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、44340
- Western Medical Center, Mexican Institute of Social Security
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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:
- Accepted as kidney donor
- Voluntary participation
- Informed consent accepted
- 85% fulfillment of atorvastatin treatment
Exclusion Criteria:
- Hypersensibility to Atorvastatin
- Smoking
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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アクティブコンパレータ：Atorvastatin
22 patients received oral atorvastatin 40 mg 1 time for day for 4 weeks
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Patients were assigned to two groups, one of them received oral atorvastatin (study group) and the other, homologated placebo (control group) for 4 weeks before a kidney transplantation.
Previous surgical procedure controls were performed
他の名前：
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プラセボコンパレーター：Placebo
22 patients received oral placebo 40 mg 1 time for day for 4 weeks
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Patients were assigned to two groups, one of them received oral atorvastatin (study group) and the other, homologated placebo (control group) for 4 weeks before a kidney transplantation.
Previous surgical procedure were performed
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
C-Reactive Protein evolution in donors
時間枠：Basal and 4 weeks later
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C-Reactive Protein was measured when patients (donors) were accepted in the study and 4 weeks later.
The last blood sample was taken the day of surgical procedure.
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Basal and 4 weeks later
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Kidney graft rejection using scale of BANFF
時間枠：Basal, 3 months and 12 months
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During surgical procedure and before organ transplantation, basal biopsy was obtain.
In the following at 3 and 12 months after kidney transplantation, were performed the other two biopsy.
Alterations between groups were registered.
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Basal, 3 months and 12 months
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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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Kidney function evolution after transplant
時間枠：24 hours, 3 months and 12 months
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In blood samples, after kidney transplantation, creatinine and urea were measured.
Differences in evolution and alteration between the 2 groups were registered
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24 hours, 3 months and 12 months
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Interleukin and tumor necrosis factor alpha.
時間枠：Basal
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During surgical procedure and before organ transplantation, the biopsy was obtain to measure interleukin 6 and tumor necrosis factor alpha, observing alteration between groups.
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Basal
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Complications
時間枠：24 hours, 3 months and 12 months
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During surgical procedure, any kind of complication was registered, the same right after surgery and in the following.
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24 hours, 3 months and 12 months
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協力者と研究者
捜査官
- スタディディレクター：Clotilde Fuentes-Orozco, PhD、Instituto Mexicano del Seguro Social
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 (見積もり)
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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