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

Sponsor
Nanjing University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01507766
Collaborator
Jinling Hospital, China (Other)
60
1
2
12
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: early enteral nutrition
  • Drug: Delayed enteral nutrition
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Enteral nutrition [14 days]

    The caloric intake and tolerance of feeding were recorded daily after enteral nutrition was started

  2. Intra-abdominal pressure [14 days]

    The value of intra-abdominal pressure (per 6 hours) and the incidence of intra-abdominal hypertension

Secondary Outcome Measures

  1. 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

  2. Immune parameters [14 days]

    IgA, IgG, IgM, CD4+/CD8+T cell and HLA-DR

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiakui Sun, Principal Investigator, Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT01507766
Other Study ID Numbers:
  • 110-85
First Posted:
Jan 11, 2012
Last Update Posted:
Nov 16, 2012
Last Verified:
Nov 1, 2012
Keywords provided by Jiakui Sun, Principal Investigator, Nanjing University School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2012