The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis
Primary Purpose
Acute Pancreatitis, Intra-abdominal Hypertension
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
early enteral nutrition
Delayed enteral nutrition
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pancreatitis focused on measuring severe acute pancreatitis, intra-abdominal pressure, 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
Sites / Locations
- Department of SICU, Research Institute of General Surgery , Jinling Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early enteral nutrition
Delayed enteral nutrition
Arm Description
The enteral nutrition was started within 48h after admission
The enteral nutrition was started at the 8th day after admission
Outcomes
Primary Outcome Measures
Enteral nutrition
The caloric intake and tolerance of feeding were recorded daily after enteral nutrition was started
Intra-abdominal pressure
The value of intra-abdominal pressure (per 6 hours) and the incidence of intra-abdominal hypertension
Secondary Outcome Measures
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
Immune parameters
IgA, IgG, IgM, CD4+/CD8+T cell and HLA-DR
Full Information
NCT ID
NCT01507766
First Posted
January 3, 2012
Last Updated
November 15, 2012
Sponsor
Nanjing University School of Medicine
Collaborators
Jinling Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT01507766
Brief Title
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
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University School of Medicine
Collaborators
Jinling Hospital, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis, Intra-abdominal Hypertension
Keywords
severe acute pancreatitis, intra-abdominal pressure, enteral nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early enteral nutrition
Arm Type
Experimental
Arm Description
The enteral nutrition was started within 48h after admission
Arm Title
Delayed enteral nutrition
Arm Type
Active Comparator
Arm Description
The enteral nutrition was started at the 8th day after admission
Intervention Type
Drug
Intervention Name(s)
early enteral nutrition
Intervention Description
The enteral nutrition was started within 48h after admission
Intervention Type
Drug
Intervention Name(s)
Delayed enteral nutrition
Intervention Description
The enteral nutrition was started at the 8th day after admission
Primary Outcome Measure Information:
Title
Enteral nutrition
Description
The caloric intake and tolerance of feeding were recorded daily after enteral nutrition was started
Time Frame
14 days
Title
Intra-abdominal pressure
Description
The value of intra-abdominal pressure (per 6 hours) and the incidence of intra-abdominal hypertension
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Clinical outcome variables
Description
Hospital mortality; Duration of ICU stay; The development of multiple organ dysfunction syndrome and pancreatic infection; APACHEII score; SOFA score; CRP levels
Time Frame
14 days
Title
Immune parameters
Description
IgA, IgG, IgM, CD4+/CD8+T cell and HLA-DR
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-qin Li, M.D.
Organizational Affiliation
Jinlin Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of SICU, Research Institute of General Surgery , Jinling Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
23674254
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.
Results Reference
derived
PubMed Identifier
23431120
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.
Results Reference
derived
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The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis
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