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Clinical Trials/NCT01507766
NCT01507766
Completed
Phase 4

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

Nanjing University School of Medicine1 site in 1 country60 target enrollmentSeptember 2010

Overview

Phase
Phase 4
Intervention
early enteral nutrition
Conditions
Acute Pancreatitis
Sponsor
Nanjing University School of Medicine
Enrollment
60
Locations
1
Primary Endpoint
Enteral nutrition
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
September 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nanjing University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Jiakui Sun

Principal Investigator

Nanjing University School of Medicine

Eligibility 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

Arms & Interventions

Early enteral nutrition

The enteral nutrition was started within 48h after admission

Intervention: early enteral nutrition

Delayed enteral nutrition

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

Intervention: Delayed enteral nutrition

Outcomes

Primary Outcomes

Enteral nutrition

Time Frame: 14 days

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

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

  • Clinical outcome variables(14 days)
  • Immune parameters(14 days)

Study Sites (1)

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