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

This study has been completed.
Sponsor:
Collaborator:
Jinling Hospital, China
Information provided by (Responsible Party):
Jiakui Sun, Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT01507766
First received: January 3, 2012
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Pancreatitis
Intra-abdominal Hypertension
 Drug: early enteral nutrition
Drug: Delayed enteral nutrition
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:
  • Enteral nutrition [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    The caloric intake and tolerance of feeding were recorded daily after enteral nutrition was started

  • Intra-abdominal pressure [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    The value of intra-abdominal pressure (per 6 hours) and the incidence of intra-abdominal hypertension


Secondary Outcome Measures:
  • Clinical outcome variables [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Hospital mortality; Duration of ICU stay; The development of multiple organ dysfunction syndrome and pancreatic infection; APACHEII score; SOFA score; CRP levels

  • Immune parameters [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    IgA, IgG, IgM, CD4+/CD8+T cell and HLA-DR


Enrollment: 60
Study Start Date: September 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507766

Locations
China, Jiangsu
Department of SICU, Research Institute of General Surgery , Jinling Hospital
Nanjing, Jiangsu, China
Sponsors and Collaborators
Nanjing University School of Medicine
Jinling Hospital, China
Investigators
Study Director: Wei-qin Li, M.D. Jinlin Hospital
  More Information

No publications provided

Responsible Party: Jiakui Sun, Principal Investigator, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT01507766     History of Changes
Other Study ID Numbers: 110-85
Study First Received: January 3, 2012
Last Updated: November 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:
severe acute pancreatitis
intra-abdominal pressure
enteral nutrition

Additional relevant MeSH terms:
Hypertension
Pancreatitis
Vascular Diseases
 Cardiovascular Diseases
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013