Suspendido

SNAPFeeding and Pancreatic Rest in Acute Pancreatitis

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Naso jejunal feeding tube insertion

+ NG feeding tube insertion

Procedimiento
Quiénes están siendo reclutados

Enfermedades del Sistema Digestivo

+ Enfermedades del páncreas

+ Pancreatitis

A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Intervencional
Inicio del estudio: enero de 2010
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity of Pittsburgh
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de enero de 2010

Fecha en la que se inscribió al primer participante.

We will compare the two types of enteral (intestinal) nutrition in regard to patients with severe acute pancreatitis in our institution and also in 8 others in the United States.

Título OficialFeeding and Pancreatic Rest in Acute Pancreatitis
NCT00580749
Patrocinador PrincipalUniversity of Pittsburgh
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 23 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.


Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades del Sistema DigestivoEnfermedades del páncreasPancreatitis

Criterios

Inclusion Criteria: 1. Patients over the age of 18yr 2. The typical history of abdominal pain for over 24h with raised (\>3-fold) serum pancreatic enzymes on admission 3. Severe pancreatitis, as defined by: the Atlanta classification of severe disease (60), but with important modifications to sharpen the definition of severity, to include one or more of the following: 1. The presence of organ failure (MOF) resistant to early aggressive IV fluid resuscitation as defined by a Marshall score of ≥2 in any one organ (for calculation, see Appendix (61)), excluding the liver component as the abnormality may be due to gall stones rather than the systemic inflammatory response (17) 2. Pancreatic necrosis \>30% on CT scan or a modified CT severity index (CTSI: see Appendix (62)) of ≥8 3. APACHE score ≥ 8 (for calculation, see Appendix (63)) 4. Ranson's criteria ≥3 (for calculation, see Appendix (64)) Exclusion Criteria: 1. Inability to absorb enteral nutrients resulting in chronic intestinal failure and need for IV feeding, such as short bowel, malabsorption disorders such as celiac or intestinal proliferative disorders, chronic obstruction and pseudo-obstruction. 2. Time elapse since commencement of acute pancreatitis symptoms \>10 days. In order to take advantage of the 'window of opportunity' to prevent the progression of 'transient' MOF to 'permanent' MOF, patients should be started on enteral feeding as soon as possible. However, in practice many patients present initially with mild disease which progresses to severe necrosis at the end of the first week, and these patients need nutritional support for long periods of time. Consequently, this is an important group to include in this investigation. Post hoc analysis will be performed to see whether they behave differently to patients fed earlier in their disease 3. Any form of artificial feeding since commencement of acute pancreatitis symptoms 4. Patients with chronic pancreatitis and pancreatic insufficiency requiring pancreatic enzyme supplements, based on clinical history and specific investigations such as by ERCP, MRP, or CT scanning. 5. Pre-existing chronic renal insufficiency requiring hemodialysis or peritoneal dialysis, as this will make assessment of severity difficult 6. Pre-existing end-stage liver disease with ascites, coagulopathy and encephalopathy, supported by biopsy, and/or radiological imaging and endoscopy (portal hypertension, varices and gastropathy), as this will make assessment of severity difficult 7. Chronic immunodeficiency states such as AIDS defined by CD-4 count \< 50, and immunoglobulin deficiencies as it may independently affect feeding tolerance and infection risk 8. Pancreatic cancer proven by biopsy, and any other form of cancer with life-expectancy \<6 months. 9. Current somatostatin or corticosteroid therapy as these drugs will impair intestinal, metabolic, and immune function, and therefore affect absorption and infection risk. 10. Contraindication to using the nose for enteral tube insertion 11. Severe traumatic brain injury with ICP\>20mmHg despite treatment 12. Previous completion or withdrawal from this study

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Comparador Activo
Naso disal jejunal(DJ) feedings randomized to 50% of subjects meeting criteria.

Grupo II

Comparador Activo
Placement of naso gastric feeding tube through nare into stomach for enteral feeding.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 4 ubicaciones

Suspendido

University of Alabama

Birmingham, United StatesAbrir University of Alabama en Google Maps
Suspendido

University of Florida College of Medicine

Gainesville, United States
Suspendido

Indiana University

Indianapolis, United States
Suspendido

University of Pittsburgh Medical Center

Pittsburgh, United States
Suspendido4 Centros de Estudio
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