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

NCT01507766 | Completed Phase 4 DMC

• 1 other identifier: 110-85
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis; Intra-abdominal Hypertension

Keywords

severe acute pancreatitis; intra-abdominal pressure; enteral nutrition

Outcome Measures

Primary Outcomes (2)

• Enteral nutrition

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

  14 days

• Intra-abdominal pressure

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

  14 days

Secondary Outcomes (2)

• Clinical outcome variables

  14 days

• Immune parameters

  14 days

Study Arms (2)

Early enteral nutrition

EXPERIMENTAL

The enteral nutrition was started within 48h after admission

Drug: early enteral nutrition

Delayed enteral nutrition

ACTIVE COMPARATOR

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

Drug: Delayed enteral nutrition

Interventions

early enteral nutrition DRUG

The enteral nutrition was started within 48h after admission

Early enteral nutrition

Delayed enteral nutrition DRUG

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

Delayed enteral nutrition

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The diagnosis of acute pancreatitis accords with the Atlanta criteria in 1992
• Within 3 days from the onset of the disease
• Hemodynamics stable

You may not qualify if:

• Decompressive measures and enteral nutrition was performed before admission
• Ileus of lower digestive tract
• Pregnant pancreatitis
• Chronic organs dysfunction
• Immunodeficiency

Sponsors & Collaborators

• Nanjing University School of Medicine: lead
• Jinling Hospital, China: collaborator

Study Sites (1)

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

Nanjing, Jiangsu, China

Location

Related Publications (2)

• Sun JK, Li WQ, Ke L, Tong ZH, Ni HB, Li G, Zhang LY, Nie Y, Wang XY, Ye XH, Li N, Li JS. Early enteral nutrition prevents intra-abdominal hypertension and reduces the severity of severe acute pancreatitis compared with delayed enteral nutrition: a prospective pilot study. World J Surg. 2013 Sep;37(9):2053-60. doi: 10.1007/s00268-013-2087-5.

  PMID: 23674254 DERIVED

• Sun JK, Mu XW, Li WQ, Tong ZH, Li J, Zheng SY. Effects of early enteral nutrition on immune function of severe acute pancreatitis patients. World J Gastroenterol. 2013 Feb 14;19(6):917-22. doi: 10.3748/wjg.v19.i6.917.

  PMID: 23431120 DERIVED

MeSH Terms

Conditions

Pancreatitis; Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wei-qin Li, M.D.

  Jinlin Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 11, 2012
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 16, 2012

Record last verified: 2012-11

Locations

CN (1)