Study of Nutrition in Acute Pancreatitis

Pancreatitis Clinical Trial

— SNAP  

Official title:

Feeding and Pancreatic Rest in Acute Pancreatitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00580749
• Other study ID #: PRO 07080011, PRO 07080044
• Secondary ID: 1 R01 DK 075803-
• Status: Terminated
• Phase: N/A
• First received: December 21, 2007
• Last updated: January 26, 2016
• Start date: January 2010
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatitis

Intervention

Procedure:
• Naso jejunal feeding tube insertion
Placement of feeding tube through nare and into jejunum for administration of enteral feeding.
• NG feeding tube insertion
Placement of naso gastric feeding tube into stomach for purpose of enteral feedings.

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	University of Florida College of Medicine	Gainesville	Florida
United States	Indiana University	Indianapolis	Indiana
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Approx. one week	No
Secondary	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.		Approx. one week	No