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

This study has been completed.
Sponsor:
Collaborator:
Jinling Hospital, China
Information provided by (Responsible Party):
Jiakui Sun, Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT01507766
First received: January 3, 2012
Last updated: November 15, 2012
Last verified: November 2012

January 3, 2012
November 15, 2012
September 2010
September 2011   (final data collection date for primary outcome measure)
  • Enteral nutrition [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    The caloric intake and tolerance of feeding were recorded daily after enteral nutrition was started
  • Intra-abdominal pressure [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    The value of intra-abdominal pressure (per 6 hours) and the incidence of intra-abdominal hypertension
  • Enteral nutrition [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Nutrition parameters(Alb, pre-Alb and weight) and the tolerance of early or delayed enteral nutrition
  • Intra-abdominal pressure [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    The value of intra-abdominal pressure(measured 1/6 hours) of every SAP patient will be recorded daily during the two weeks after admission.
Complete list of historical versions of study NCT01507766 on ClinicalTrials.gov Archive Site
  • Clinical outcome variables [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Hospital mortality; Duration of ICU stay; The development of multiple organ dysfunction syndrome and pancreatic infection; APACHEII score; SOFA score; CRP levels
  • Immune parameters [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    IgA, IgG, IgM, CD4+/CD8+T cell and HLA-DR
  • Inflammation parameters [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    IL-6,IL-10 and CRP level
  • Scoring system [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    APACHEII score, SOFA score, Balthazar CT score
  • Immune parameters [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    IgA, IgG, IgM, CD4+/CD8+T cell and HLA-DR
  • Mucosal barrier parameters [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Endotoxin, TNF-a, Fatty acid binding protein
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Acute Pancreatitis
  • Intra-abdominal Hypertension
  • Drug: early enteral nutrition
    The enteral nutrition was started within 48h after admission
  • Drug: Delayed enteral nutrition
    The enteral nutrition was started at the 8th day after admission
  • Experimental: Early enteral nutrition
    The enteral nutrition was started within 48h after admission
    Intervention: Drug: early enteral nutrition
  • Active Comparator: Delayed enteral nutrition
    The enteral nutrition was started at the 8th day after admission
    Intervention: Drug: Delayed enteral nutrition

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01507766
110-85
Yes
Jiakui Sun, Nanjing University School of Medicine
Nanjing University School of Medicine
Jinling Hospital, China
Study Director: Wei-qin Li, M.D. Jinlin Hospital
Nanjing University School of Medicine
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP