Study of Nutrition in Acute Pancreatitis (SNAP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00580749
First received: December 21, 2007
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

We will compare the two types of enteral (intestinal) nutrition in regard to patients with severe acute pancreatitis in our institution and also in 8 others in the United States.


Condition Intervention
Pancreatitis
Procedure: Naso jejunal feeding tube insertion
Procedure: NG feeding tube insertion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feeding and Pancreatic Rest in Acute Pancreatitis

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Feeding success as determined by the quantity of nutrition delivered and the number of interruptions due to intolerance and how the two forms of feeding influence disease outcome as measured by duration of ICU and hospital stay. [ Time Frame: Approx. one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feeding tolerance (nitrogen balance, stool volume, incidence of nausea, incidence of nausea and vomiting) will demonstrate better tolerance for subjects undergoing DJ feeding than those undergoing NG feeding. [ Time Frame: Approx. one week ] [ Designated as safety issue: No ]

Estimated Enrollment: 135
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DJ
Naso disal jejunal(DJ) feedings randomized to 50% of subjects meeting criteria.
Procedure: Naso jejunal feeding tube insertion
Placement of feeding tube through nare and into jejunum for administration of enteral feeding.
Active Comparator: NG
Placement of naso gastric feeding tube through nare into stomach for enteral feeding.
Procedure: NG feeding tube insertion
Placement of naso gastric feeding tube into stomach for purpose of enteral feedings.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients over the age of 18yr
  2. The typical history of abdominal pain for over 24h with raised (>3-fold) serum pancreatic enzymes on admission
  3. Severe pancreatitis, as defined by: the Atlanta classification of severe disease (60), but with important modifications to sharpen the definition of severity, to include one or more of the following:

    1. The presence of organ failure (MOF) resistant to early aggressive IV fluid resuscitation as defined by a Marshall score of ≥2 in any one organ (for calculation, see Appendix (61)), excluding the liver component as the abnormality may be due to gall stones rather than the systemic inflammatory response (17)
    2. Pancreatic necrosis >30% on CT scan or a modified CT severity index (CTSI: see Appendix (62)) of ≥8
    3. APACHE score ≥ 8 (for calculation, see Appendix (63))
    4. Ranson's criteria ≥3 (for calculation, see Appendix (64))

Exclusion Criteria:

  1. Inability to absorb enteral nutrients resulting in chronic intestinal failure and need for IV feeding, such as short bowel, malabsorption disorders such as celiac or intestinal proliferative disorders, chronic obstruction and pseudo-obstruction.
  2. Time elapse since commencement of acute pancreatitis symptoms >10 days. In order to take advantage of the 'window of opportunity' to prevent the progression of 'transient' MOF to 'permanent' MOF, patients should be started on enteral feeding as soon as possible. However, in practice many patients present initially with mild disease which progresses to severe necrosis at the end of the first week, and these patients need nutritional support for long periods of time. Consequently, this is an important group to include in this investigation. Post hoc analysis will be performed to see whether they behave differently to patients fed earlier in their disease
  3. Any form of artificial feeding since commencement of acute pancreatitis symptoms
  4. Patients with chronic pancreatitis and pancreatic insufficiency requiring pancreatic enzyme supplements, based on clinical history and specific investigations such as by ERCP, MRP, or CT scanning.
  5. Pre-existing chronic renal insufficiency requiring hemodialysis or peritoneal dialysis, as this will make assessment of severity difficult
  6. Pre-existing end-stage liver disease with ascites, coagulopathy and encephalopathy, supported by biopsy, and/or radiological imaging and endoscopy (portal hypertension, varices and gastropathy), as this will make assessment of severity difficult
  7. Chronic immunodeficiency states such as AIDS defined by CD-4 count < 50, and immunoglobulin deficiencies as it may independently affect feeding tolerance and infection risk
  8. Pancreatic cancer proven by biopsy, and any other form of cancer with life-expectancy <6 months.
  9. Current somatostatin or corticosteroid therapy as these drugs will impair intestinal, metabolic, and immune function, and therefore affect absorption and infection risk.
  10. Contraindication to using the nose for enteral tube insertion
  11. Severe traumatic brain injury with ICP>20mmHg despite treatment
  12. Previous completion or withdrawal from this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580749

Contacts
Contact: David Whitcomb, MD (412) 578-9517 whitcomb@pitt.edu
Contact: Tina Vita, RN 412-647-9652 vitatm@upmc.edu

Locations
United States, Alabama
University of Alabama Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact: Mel Wilcox, MD    205-975-4658    melw@uab.edu   
Contact: Stacy Branham, RN    205 996-7378    sbranham@uab.edu   
Principal Investigator: Mel Wilcox, MD         
United States, Florida
University of Florida College of Medicine Recruiting
Gainesville, Florida, United States, 32610
Contact: Christopher Forsmark, MD    352-392-2877    chris.forsmark@medicine.ufl.edu   
Contact: April Goddard, PA-C    352-392-2877    april.tilton@medicine.ufl.edu   
Principal Investigator: Christopher Forsmark, MD         
United States, Indiana
Indiana University Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Greg Cote, MD    317-944-2740    gcote@iupui.edu   
Contact: Suzette Schmidt, RN    317-948-8104    suschmid@iupui.edu   
Principal Investigator: Greg Cote, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Stephen J O'Keefe, MD, MSc    412-648-7217    sjokeefe@pitt.edu   
Contact: Tina Vita, RN    412-647-9652    vitatm@umpc.edu   
Principal Investigator: Stephen O'Keefe, MD         
United States, Tennessee
Vanderbilt University Not yet recruiting
Nashville, Tennessee, United States, 37212-1610
Contact: Bill Nealon, MD    615-322-4643    william.nealon@vanderbilt.edu   
Contact: Pennie Bell, RN    615-322-1897    pennie.bell@vanderbilt.edu   
Principal Investigator: Bill Nealon, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: David Whitcomb, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Dr. David Whitcomb, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00580749     History of Changes
Other Study ID Numbers: PRO 07080011, PRO 07080044, 1 R01 DK 075803-01A1 NIH#
Study First Received: December 21, 2007
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Pancreatitis
enteral feeding
distal jejunal feeding
naso gastric feeding
pancreatic rest

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 27, 2014