Total Parenteral Nutrition-Associated Liver Disease

• Status: Terminated
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to determine whether choline, when added to total parenteral nutrition (TPN), can help prevent the development of hepatic steatosis, a liver disease, in patients on TPN.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Treatments: Choline

Criteria

Inclusion criteria:

• Underlying pathology may include, but is not limited to: short bowel syndrome, chronic pancreatitis, pancreatic pseudocysts, pseudo-obstruction, enterocutaneous fistula, entero-enteric fistula, or malabsorption syndrome.

• Requirement for TPN to supply greater than 85 percent of nutritional needs for at least 16 weeks.

Exclusion criteria:

• Not receiving lipid emulsion with TPN regimen

• Albumin less than 2.5 g/L

• Renal failure requiring hemo- or peritoneal dialysis

• Hepatic failure (PT greater than 2 times control)

• Diabetes

• Hepatitis C

• AIDS

• Concurrent hospitalization for organ transplantation or rejection treatment

• Concurrent cholinergic medication

• Positive pregnancy test

• Refusal to use an acceptable method of birth control

• Ethanol abuse

• More than 40 kcal/kg/day ideal body weight

• Obesity with ensuing weight loss

• Use of IV tetracycline, valproic acid, corticosteroids, methotrexate, or amiodarone