Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury

NCT02780193 | Unknown

• 1 other identifier: 14051906
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to provide intravenous omega-3 fatty acids and monitor tolerance in subjects with prolonged parenteral nutrition dependence and parenteral nutrition-associated cholestasis through expanded access.

Conditions

Cholestasis; Total Parenteral Nutrition-induced Cholestasis

Interventions

Omegaven DRUG

Therapy with Omegaven® will be initiated and maintained at 1 g/kg/day. It will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. If additional non-protein calories are needed, they will be provided as carbohydrates. No other parenteral form of fat emulsion will be used during Omegaven® therapy.The Omegaven® dose may be discontinued if the subject is receiving adequate enteral nutrition to meet metabolic and growth needs.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients from birth to 18 years of age who:
• are receiving PN,
• are predicted to receive at least another 30 days of PN, and
• have liver disease with at least a serum direct (conjugated) bilirubin ≥ 2 mg/dL
• Patients from birth to 18 years of age who have a soybean allergy (per parental report) and require parenteral fat
• Patients with significant liver disease due to parenteral nutrition despite utilization of all appropriate conventional therapies.
• Signed patient/parent informed consent
• Hospitalized due to medical or surgical condition prior to Omegaven initiation

You may not qualify if:

• Those who choose not to consent to the study
• Those in whom 3rd party funding is not secured to support this investigational treatment
• Known fish or egg protein allergy (per parental report)
• All other causes of liver disease (cystic fibrosis, biliary atresia, and alpha 1 anti- trypsin deficiency)
• Severe hemorrhagic disorders (platelet count below 50000)
• Collapse and shock
• Embolism
• Undefined coma status
• Impaired lipid metabolism (serum triglycerides \> 200 mg/dL on 1 g/kg/day intralipid)
• Unstable diabetes mellitus
• Stroke
• Recent cardiac infarction

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

• Puder M, Valim C, Meisel JA, Le HD, de Meijer VE, Robinson EM, Zhou J, Duggan C, Gura KM. Parenteral fish oil improves outcomes in patients with parenteral nutrition-associated liver injury. Ann Surg. 2009 Sep;250(3):395-402. doi: 10.1097/SLA.0b013e3181b36657.

  PMID: 19661785 BACKGROUND

• Gura KM, Lee S, Valim C, Zhou J, Kim S, Modi BP, Arsenault DA, Strijbosch RA, Lopes S, Duggan C, Puder M. Safety and efficacy of a fish-oil-based fat emulsion in the treatment of parenteral nutrition-associated liver disease. Pediatrics. 2008 Mar;121(3):e678-86. doi: 10.1542/peds.2007-2248.

  PMID: 18310188 BACKGROUND

MeSH Terms

Conditions

Cholestasis

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Aloka L Patel, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: May 23, 2016
• Last Updated: April 8, 2019

Record last verified: 2019-04

Locations

US (1)