Clinical trial NCT01507766: The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis
Official title: The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pancreatitis
Intra-abdominal Hypertension
Keywords: severe acute pancreatitis
intra-abdominal pressure
enteral nutrition
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
Collaborators: name: Jinling Hospital, China
First posted: 2012-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Enteral nutrition
timeFrame: 14 days
measure: Intra-abdominal pressure
timeFrame: 14 days
Secondary outcomes:
measure: Clinical outcome variables
timeFrame: 14 days
measure: Immune parameters
timeFrame: 14 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of SICU, Research Institute of General Surgery , Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Jinlin Hospital
name: Wei-qin Li, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.