Study of Glycemic Control on Liver Transplantation Outcomes
Prospective, Randomized, Open-Label, Controlled Study to Evaluate the Safety and Efficacy of Intensive Glycemic Control on Outcomes Following Liver Transplantation
調査の概要
詳細な説明
Many studies have shown improvement in morbidity and mortality with intensive glycemic management postoperatively. However, some recent studies have not been able to reproduce these benefits and have raised the issue of adverse consequences of hypoglycemia associated with intensive therapy. Our own data show an association of increased graft rejection proportional to postoperative glucose levels in patients who have undergone a liver transplant. Preliminary data suggest that this may improved by better glycemic control using the Glucose Management Service here at Northwestern.
In this study, we propose to determine whether improved glycemic control using intensive insulin treatment immediately postoperatively will improve outcomes in patients undergoing liver transplant using a prospective, controlled, randomized, parallel-group study design targeting two different glucose levels, 140 and 180 mg/dL. Postoperative glucose management with insulin will be supervised by the Glucose Management Service as is routine, with the only research aspect being the two different glucose targets and the outcome analysis with liver transplant rejection as the primary outcome and infections and hypoglycemia being the principle secondary outcomes.
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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Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern University Feinberg School of Medicine
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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:
- Require Liver Transplantation
- Age 18 - 80
- Able to give informed consent personally or via a family member who has appropriate authorization to do so if patient unconscious.
- Expected survival following transplantation for > 1 year.
- Glucose level over 180 mg/dL postoperatively
Exclusion Criteria:
- Inability of patient or family member to give informed consent
- Not expected to survive for > 1 year following liver transplantation.
- Previous liver transplantation
- Acute liver failure
- Living related donor
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: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 |
---|---|
アクティブコンパレータ:140 Group
Insulin treatment to target blood glucose at 140 mg/dl
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Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
他の名前:
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アクティブコンパレータ:180 Group
Insulin treatment to target blood glucose at 180 mg/dl
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Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
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 |
---|---|---|
Rejection of Liver Transplant
時間枠:within 1 year of transplantation
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Liver transplant rejection determined by either biopsy or clinical criteria (>2x transaminases, clinical decision, treatment with high dose steroids and other anti-rejection medications
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within 1 year of transplantation
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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 |
---|---|---|
Hypoglycemia
時間枠:Within first 3 days following transplantation
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Participants experiencing hypoglycemia (glucose < 70 mg/dL) within the first 3- days following transplantation
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Within first 3 days following transplantation
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Infection Rates
時間枠:Within 1 year following transplantation
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Within 1 year following transplantation
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Rehospitalization Rates
時間枠:Within 1 year following transplantation
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Within 1 year following transplantation
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Overall Graft Survival at 1 Year
時間枠:1 year following transplantation
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1 year following transplantation
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Death Within 1 Year
時間枠:1 year
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Death following liver transplant between 1 day and 1 year
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1 year
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Mark E Molitch, M.D.、Northwestern University Feinberg School of Medicine
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Insulinの臨床試験
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Julphar Gulf Pharmaceutical IndustriesParexel; Profil Institut für Stoffwechselforschung GmbH完了
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Julphar Gulf Pharmaceutical IndustriesProfil Institut für Stoffwechselforschung GmbH完了
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Sanofi終了しました