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

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507766
• Other study ID #: 110-85
• Status: Completed
• Phase: Phase 4
• First received: January 3, 2012
• Last updated: November 15, 2012
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2012
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pancreatitis
• Intra-abdominal Hypertension
• Pancreatitis

Intervention

Drug:
• early enteral nutrition
The enteral nutrition was started within 48h after admission
• Delayed enteral nutrition
The enteral nutrition was started at the 8th day after admission

Locations

Country	Name	City	State
China	Department of SICU, Research Institute of General Surgery , Jinling Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing University School of Medicine	Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enteral nutrition	The caloric intake and tolerance of feeding were recorded daily after enteral nutrition was started	14 days	Yes
Primary	Intra-abdominal pressure	The value of intra-abdominal pressure (per 6 hours) and the incidence of intra-abdominal hypertension	14 days	Yes
Secondary	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	Yes
Secondary	Immune parameters	IgA, IgG, IgM, CD4+/CD8+T cell and HLA-DR	14 days	Yes