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

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

Sponsors

Lead Sponsor: Nanjing University School of Medicine

Collaborator: Jinling Hospital, China

Source Nanjing University School of Medicine
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.

Overall Status Completed
Start Date September 2010
Completion Date September 2011
Primary Completion Date September 2011
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Enteral nutrition 14 days
Intra-abdominal pressure 14 days
Secondary Outcome
Measure Time Frame
Clinical outcome variables 14 days
Immune parameters 14 days
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: early enteral nutrition

Description: The enteral nutrition was started within 48h after admission

Arm Group Label: Early enteral nutrition

Intervention Type: Drug

Intervention Name: Delayed enteral nutrition

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

Arm Group Label: Delayed enteral nutrition

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Wei-qin Li, M.D. Study Director Jinlin Hospital
Location
Facility: Department of SICU, Research Institute of General Surgery , Jinling Hospital
Location Countries

China

Verification Date

November 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Nanjing University School of Medicine

Investigator Full Name: Jiakui Sun

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Early enteral nutrition

Type: Experimental

Description: The enteral nutrition was started within 48h after admission

Label: Delayed enteral nutrition

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov