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

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ClinicalTrials.gov Identifier: NCT01507766
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : November 16, 2012
Sponsor:
Collaborator:
Jinling Hospital, China
Information provided by (Responsible Party):
Jiakui Sun, Nanjing University School of Medicine

Tracking Information
First Submitted Date  ICMJE January 3, 2012
First Posted Date  ICMJE January 11, 2012
Last Update Posted Date November 16, 2012
Study Start Date  ICMJE September 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2012)
  • Enteral nutrition [ Time Frame: 14 days ]
    The caloric intake and tolerance of feeding were recorded daily after enteral nutrition was started
  • Intra-abdominal pressure [ Time Frame: 14 days ]
    The value of intra-abdominal pressure (per 6 hours) and the incidence of intra-abdominal hypertension
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
  • Intra-abdominal pressure [ Time Frame: 14 days ]
    The value of intra-abdominal pressure(measured 1/6 hours) of every SAP patient will be recorded daily during the two weeks after admission.
  • Enteral nutrition [ Time Frame: 14 days ]
    Nutrition parameters(Alb, pre-Alb and weight) and the tolerance of early or delayed enteral nutrition
Change History Complete list of historical versions of study NCT01507766 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2012)
  • Clinical outcome variables [ Time Frame: 14 days ]
    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 ]
    IgA, IgG, IgM, CD4+/CD8+T cell and HLA-DR
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
  • Inflammation parameters [ Time Frame: 14 days ]
    IL-6,IL-10 and CRP level
  • Scoring system [ Time Frame: 14 days ]
    APACHEII score, SOFA score, Balthazar CT score
  • Immune parameters [ Time Frame: 14 days ]
    IgA, IgG, IgM, CD4+/CD8+T cell and HLA-DR
  • Mucosal barrier parameters [ Time Frame: 14 days ]
    Endotoxin, TNF-a, Fatty acid binding protein
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis
Official Title  ICMJE The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Pancreatitis
  • Intra-abdominal Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2012)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01507766
Other Study ID Numbers  ICMJE 110-85
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiakui Sun, Nanjing University School of Medicine
Study Sponsor  ICMJE Nanjing University School of Medicine
Collaborators  ICMJE Jinling Hospital, China
Investigators  ICMJE
Study Director: Wei-qin Li, M.D. Jinlin Hospital
PRS Account Nanjing University School of Medicine
Verification Date November 2012

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