Early Nutrition in Acute Pancreatitis (OZT)

Medical University of Warsaw

Status: Unknown

Conditions: Acute Pancreatitis

Treatments: Other: Early diet intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03820128

OZT

Details and patient eligibility

About

The aim of the study is to assess the effect of the early oral refeeding and fat content in the diet on the length of stay, clinical course (included pain severity) in pediatric patients with mild and moderate AP. Patients will be randomized to groups: refeeding within 24 hours or after 24 hours from the hospital admission. Biochemical tests and pain severity will be evaluated.

Full description

Prospective, randomized study. Research in the adult population shows that early enteral feeding in acute pancreatitis (AP) both oral and via the feeding tube is safe, shortens the length of hospital stay, prevents the multi organ failure (MoF) and reduces mortality. The pediatric population lacks prospective data concerning refeeding modes in AP. The aim of the study is to assess the effect of the early oral refeeding and fat content in the diet on the length of stay, clinical course (included pain severity) in pediatric patients with mild and moderate AP. Patients will be randomized to groups: refeeding within 24 hours or after 24 hours from the hospital admission. Biochemical tests including CRP, amylase, lipase and proinflammatory cytokines levels and zonulin level as well as severity of pain will be assessed again in the second, the third and the fifth hospital day.

Enrollment: 84 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

84 participants in 2 patient groups

Very early refeeding

Active Comparator group

Description:

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.

Treatment:

Other: Early diet intervention

Early refeeding

Active Comparator group

Description:

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.

Treatment:

Other: Early diet intervention