- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03820128
Early Nutrition in Acute Pancreatitis (OZT)
Very Early and Early Nutrition in Acute Pancreatitis in Children: a Randomized Study
Studieoversikt
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Warsaw, Polen, 02-091
- Departement of Paediatric Gastroenterology and Nutrition.
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Length of hospitalization
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Time between the onset of symptoms and the first feeding
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- OZT
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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