Study of Nutrition in Acute Pancreatitis (SNAP)
This study is currently recruiting participants.
Verified August 2011 by University of Pittsburgh
Sponsor:
University of Pittsburgh
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
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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:
- Patients over the age of 18yr
- The typical history of abdominal pain for over 24h with raised (>3-fold) serum pancreatic enzymes on admission
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:
- 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)
- Pancreatic necrosis >30% on CT scan or a modified CT severity index (CTSI: see Appendix (62)) of ≥8
- APACHE score ≥ 8 (for calculation, see Appendix (63))
- Ranson's criteria ≥3 (for calculation, see Appendix (64))
Exclusion Criteria:
- 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.
- 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
- Any form of artificial feeding since commencement of acute pancreatitis symptoms
- 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.
- Pre-existing chronic renal insufficiency requiring hemodialysis or peritoneal dialysis, as this will make assessment of severity difficult
- 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
- 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
- Pancreatic cancer proven by biopsy, and any other form of cancer with life-expectancy <6 months.
- Current somatostatin or corticosteroid therapy as these drugs will impair intestinal, metabolic, and immune function, and therefore affect absorption and infection risk.
- Contraindication to using the nose for enteral tube insertion
- Severe traumatic brain injury with ICP>20mmHg despite treatment
- Previous completion or withdrawal from this study
Contacts and Locations
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 May 16, 2013