Early Nutrition in Acute Pancreatitis (OZT)
Very Early and Early Nutrition in Acute Pancreatitis in Children: a Randomized Study
Studieöversikt
Detaljerad beskrivning
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Warsaw, Polen, 02-091
- Departement of Paediatric Gastroenterology and Nutrition.
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: 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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Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Length of hospitalization
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Time between the onset of symptoms and the first feeding
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
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