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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pancreatitis; Intra-abdominal Hypertension
• Intervention / Treatment: Drug: early enteral nutrition; Drug: Delayed enteral nutrition

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Department of SICU, Research Institute of General Surgery , Jinling Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanjing University School of Medicine
• Collaborators: Jinling Hospital, China
• Investigators: Study Director: Wei-qin Li, M.D., Jinlin Hospital

Publications and helpful links

General Publications

• Sun JK, Li WQ, Ke L, Tong ZH, Ni HB, Li G, Zhang LY, Nie Y, Wang XY, Ye XH, Li N, Li JS. Early enteral nutrition prevents intra-abdominal hypertension and reduces the severity of severe acute pancreatitis compared with delayed enteral nutrition: a prospective pilot study. World J Surg. 2013 Sep;37(9):2053-60. doi: 10.1007/s00268-013-2087-5.
• Sun JK, Mu XW, Li WQ, Tong ZH, Li J, Zheng SY. Effects of early enteral nutrition on immune function of severe acute pancreatitis patients. World J Gastroenterol. 2013 Feb 14;19(6):917-22. doi: 10.3748/wjg.v19.i6.917.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: January 3, 2012
• First Submitted That Met QC Criteria: January 10, 2012
• First Posted (Estimate): January 11, 2012

Study Record Updates

• Last Update Posted (Estimate): November 16, 2012
• Last Update Submitted That Met QC Criteria: November 15, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: intra-abdominal pressure; enteral nutrition; severe acute pancreatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Muscular Diseases; Pancreatic Diseases; Compartment Syndromes; Pancreatitis; Intra-Abdominal Hypertension
• Other Study ID Numbers: 110-85