The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis

Study Overview
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Brief Summary
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As an important management of severe acute pancreatitis (SAP), enteral nutrition (EN), especially early enteral nutrition (EEN) increases the blood flow of gut mucosa and stimulates the intestinal motility. Moreover, EEN maintains the gut integrity, prevents bacterial and endotoxin translocation and thereby theoretically reduces the incidence of infections. Therefore, EEN has the ability to reduce the infectious complications, length of hospital stay and mortality of patients with SAP. However, the role of EEN is considered to be influenced by intra-abdominal hypertension (IAH) in patients with SAP. The previous studies showed that gut was the most sensitive splanchnic organ to the increase of intra-abdominal pressure (IAP). When IAH occurs, it reduces the blood flow of gut, and then results in the development of intestinal ischemia and edema. The hypoxia and hypoperfusion of intestine leads to the increase of permeability of the intestinal mucosal barrier, and then leads to bacterial translocation. Therefore, IAH could result in the gastrointestinal dysfunction. Nevertheless, the different impacts of specific IAP values on the tolerance of EEN have not been reported. Furthermore, the effects of early enteral feeding on the IAP in SAP also remain unknown. Due to the severe inflammatory response of SAP, could EEN increase the burden of bowel, cause expansion of intestinal cavity, thus increase IAP? However, there were rare literatures up to date reporting the association between EEN and IAH in patients with SAP. Therefore, the present study aimed to investigate the influence of specific IAP on the tolerance of early enteral feeding, as well as the effects of EEN on IAP in SAP patients. Moreover, the impacts of EEN on the disease severity and clinical outcome of SAP were also researched.

Official Title
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The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis

Conditions
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Acute Pancreatitis, Intra-abdominal Hypertension

Intervention / Treatment
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* Drug: early enteral nutrition
* Drug: Delayed enteral nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of acute pancreatitis accords with the Atlanta criteria in 1992 Within 3 days from the onset of the disease Hemodynamics stable Exclusion Criteria: Decompressive measures and enteral nutrition was performed before admission Ileus of lower digestive tract Pregnant pancreatitis Chronic organs dysfunction Immunodeficiency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early enteral nutrition<br>The enteral nutrition was started within 48h after admission | Drug: early enteral nutrition<br>* The enteral nutrition was started within 48h after admission<br>|
| Active Comparator: Delayed enteral nutrition<br>The enteral nutrition was started at the 8th day after admission | Drug: Delayed enteral nutrition<br>* The enteral nutrition was started at the 8th day after admission<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enteral nutrition | The caloric intake and tolerance of feeding were recorded daily after enteral nutrition was started | 14 days | 
| Intra-abdominal pressure | The value of intra-abdominal pressure (per 6 hours) and the incidence of intra-abdominal hypertension | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome variables | Hospital mortality; Duration of ICU stay; The development of multiple organ dysfunction syndrome and pancreatic infection; APACHEII score; SOFA score; CRP levels | 14 days | 
| Immune parameters | IgA, IgG, IgM, CD4+/CD8+T cell and HLA-DR | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe acute pancreatitis, intra-abdominal pressure, enteral nutrition