Study of the Diet in Patients With the Diagnostic of Acute Pancreatitis
キーワード
概要
説明
This is prospective, randomized, controlled, multicentre trial. Patients with mild and moderate acute pancreatitis (AP) will be randomly in two groups: group A: with early oral refeeding (EOR) with low fat solid diet (LFSD), started from the first day of admission in the hospital, and group B: with Nil Per Oral (NPO), until the symptoms, signs, inflammatory parameters of AP have resolved.
The primary and several secondary endpoints will be obtained and EORF with LFSD will improve the following measures of outcome:
1. Length of hospital admission (the primary endpoint)
2. Serum amylase, lipase, electrolytes, calcium, urea, creatinine, liver function tests, C-reactive protein (biomarker of inflammation), nutritional parameters (albumin, prealbumin, cholesterol, triglycerides) and full blood count - routine blood tests performed daily until normalization of serum lipase or until discharge.
3. Weight, at hospital admission and discharge, and at day 30 post-discharge clinic follow-up.
4. Systemic complications including hemodynamic instability, renal failure, intensive care admission, surgery, radiological and endoscopic procedures.
5. Pain and Analgesic requirement.
6. Local complications including pancreatic necrosis, abscess, pseudocyst.
日付
| 最終確認済み: | 01/31/2019 |
| 最初に提出された: | 01/26/2019 |
| 提出された推定登録数: | 01/30/2019 |
| 最初の投稿: | 02/03/2019 |
| 最終更新が送信されました: | 01/31/2019 |
| 最終更新日: | 02/04/2019 |
| 実際の研究開始日: | 05/31/2017 |
| 一次完了予定日: | 12/30/2018 |
| 研究完了予定日: | 12/30/2018 |
状態または病気
介入/治療
Other: Early oral refeeding
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Active Comparator: Early oral refeeding The patients will be started the oral refeeding from the first day of admission in the hospital.
Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day | Other: Early oral refeeding the oral refeeding will be started after admission. Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day |
| No Intervention: FASTING The oral diet will be reintroduced in a traditional stepwise manner until the symptoms, signs, inflammatory parameters of AP have resolved |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - 1) Diagnosed of AP by at least two of these three criteria: compatible abdominal pain, amylase or lipase level superior in three-fold respective laboratory baseline levels, and suitable findings in imaging techniques (CT, ultrasound or MRI) - 2) age > 18 years, sign consent form. Exclusion Criteria: - 1) pregnant o breastfeeding women; - 2) abdominal pain lasting >96 horas before admission; - 3) the possibility of poor oral intake for reasons other than AP; - 4) Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology; - 5) Chronic pancreatitis; - 6) Randomization greater the 12 hours after admission |
結果
主な結果の測定
1. Length of hospitalization [measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days.]
二次的な結果の測定
1. Relapse of abdominal pain [measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days, and during the follow up (1 month after discharge)]
2. Duration of fasting [2-3 days approximately since the first day of hospital admission]
3. Tolerance to food [2-7 days approximately during hospital admission and during the follow up]
4. Elevation of serum amylase or lipase [2-4 days approximately during hospital admission after oral refeeding, until hospital discharge]
5. Intra-abdominal infection [1 month]
6. Death [During hospital stay (up to 1 day)]
7. Operation rate [2 month]
