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

Phase 4

Completed

• Conditions: Acute Pancreatitis; Intra-abdominal Hypertension
• Interventions: Drug: early enteral nutrition; Drug: Delayed enteral nutrition

• Registration Number: NCT01507766
• Lead Sponsor: Nanjing University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-11
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-15
• Last Update Posted: 2012-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early enteral nutrition	early enteral nutrition	The enteral nutrition was started within 48h after admission
Delayed enteral nutrition	Delayed enteral nutrition	The enteral nutrition was started at the 8th day after admission

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of SICU, Research Institute of General Surgery , Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China