Study of Nutrition in Acute Pancreatitis

NCT ID: NCT00580749

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-05-31

Brief 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.

Conditions

Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DJ

Naso disal jejunal(DJ) feedings randomized to 50% of subjects meeting criteria.

Group Type: ACTIVE_COMPARATOR

Naso jejunal feeding tube insertion

Intervention Type: PROCEDURE

Placement of feeding tube through nare and into jejunum for administration of enteral feeding.

NG

Placement of naso gastric feeding tube through nare into stomach for enteral feeding.

Group Type: ACTIVE_COMPARATOR

NG feeding tube insertion

Intervention Type: PROCEDURE

Placement of naso gastric feeding tube into stomach for purpose of enteral feedings.

Interventions

Naso jejunal feeding tube insertion

Placement of feeding tube through nare and into jejunum for administration of enteral feeding.

Intervention Type: PROCEDURE

NG feeding tube insertion

Placement of naso gastric feeding tube into stomach for purpose of enteral feedings.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

David Whitcomb

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Whitcomb, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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, United States

Countries

United States

Other Identifiers

1 R01 DK 075803-01A1 NIH#

Identifier Type: -

Identifier Source: secondary_id

PRO 07080011, PRO 07080044

Identifier Type: -

Identifier Source: org_study_id