Early Nutrition in Acute Pancreatitis (OZT)
Very Early and Early Nutrition in Acute Pancreatitis in Children: a Randomized Study
調査の概要
詳細な説明
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Warsaw、ポーランド、02-091
- Departement of Paediatric Gastroenterology and Nutrition.
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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:
AP diagnosis according to the generally accepted criteria ie. fulfilling two out of three criteria:
- Abdominal pain of pancreatic origin
- Radiologic findings supportive of AP on imaging
- Amylase or lipase levels elevation three times above the upper limit of normal
- Mild or moderate AP Mild AP: AP without organ failure, local or general complications Moderate AP: AP that may be accompanied by intermittent organ failure, local complications or concomitant disease worsening
- No contradictions to enteral treatment
- Informed consent from the parents or legal guardian and from the patient if older than 16 years
Exclusion Criteria:
- Severe general condition
- Severe AP
- Kidney insufficiency, cardiac insufficiency
- Diabetes type 1
- Cystic fibrosis
- Contraindications to enteral feeding
- Lack of required informed consent
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：支持療法
- 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：Very early refeeding
Very early diet intervention: refeeding within 24 hours from the hospital admission. Participants will be encouraged to start eating immediately after the time of admission. They will be able to choose the meal from the list with no amount or calories restriction.They will be asked to conduct the daily diet diary - time of feeding, quality and quantity of the foods ingested. Laboratory tests will be performed at the study entry, on the day of 3 and 5 of hospitalization and on the day of discharge. |
Participant's diet includes several low-fiber and low-fat commonly available meals and products.
Patients will choose what they want to eat with no amount or calories restriction.
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アクティブコンパレータ：Early refeeding
Early diet intervention: refeeding after 24 hours from the hospital admission . During the first 24 hours after admission participants will be on fluid only (orally and/or intravenously). Later on they will be encouraged to start eating. They will be able to choose the meal from the list with no amount or calories restriction.They will be asked to conduct the daily diet diary - time of feeding, quality and quantity of the foods ingested. Laboratory tests will be performed at the study entry, on the day of 3 and 5 of hospitalization and on the day of discharge. |
Participant's diet includes several low-fiber and low-fat commonly available meals and products.
Patients will choose what they want to eat with no amount or calories restriction.
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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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Length of hospitalization
時間枠：through study completion, an average of 2 years
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Number days of hospitalization
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through study completion, an average of 2 years
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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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Time between the onset of symptoms and the first feeding
時間枠：assessed at the day of 2
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Time between the onset of symptoms and the first feeding measured in hours
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assessed at the day of 2
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Adverse events
時間枠：daily assessment in the first three days of hospitalization
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Severity of abdominal pain daily using a 10 point visual - analog scale (VAS).
0 means lack of the pain, 10 means the most severe pain
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daily assessment in the first three days of hospitalization
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Average calories intake
時間枠：through study completion, an average of 2 years
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Average calories intake (kcal)
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through study completion, an average of 2 years
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Levels of proinflammatory cytokine levels.
時間枠：through study completion, an average of 2 years
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Proinflammatory cytokine levels (ng/ml) using ELISA tests
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through study completion, an average of 2 years
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Zonulin level
時間枠：through study completion, an average of 2 years
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Zonulin level (ng/ml) using ELISA test
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through study completion, an average of 2 years
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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
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。