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Completed

NCT Number: NCT01507766

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of SICU, Research Institute of General Surgery , Jinling Hospital

Nanjing, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

early enteral nutrition

Drug

The enteral nutrition was started within 48h after admission

Delayed enteral nutrition

Drug

The enteral nutrition was started at the 8th day after admission

Primary outcomes

  1. Enteral nutrition

    Time frame: 14 days

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

  2. Intra-abdominal pressure

    Time frame: 14 days

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

Secondary outcomes

  1. Clinical outcome variables

    Time frame: 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

    Time frame: 14 days

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

Sponsors and collaborators

Lead sponsor

Nanjing University School of Medicine

Other

Collaborators

  • Jinling Hospital, China

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 11, 2012
Registry last updated
Nov 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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