Wounds and Injuries

All Conditions

This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks.

initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month.

Omegaven

Pankaj Vashi, MD

The purposes of this study are to make Omegaven® available to cancer patients with liver disease and to determine if Omegaven® can improve or prevent further liver disease. The study will also look at the effects Omegaven® has on immune function.

This compassionate use study will include patients with advanced cancer requiring PN for long-term nutrition support who have developed PN-induced hepatic injury or who have existing hepatic dysfunction. Therapy with Omegaven will be provided at an initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. For patients \> 120% ideal body weight, adjusted body weight will be used. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Omegaven will be co-administered via a y-site infusion, with containers being changed every 12 hours. The patient may receive other lipids to meet Essential Fatty Acid (EFA) and/or additional calorie needs. Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. If an adverse reaction is observed, IV steroids \& benadryl will be administered \& Omegaven will be discontinued. Patients will continue to receive infusions at CTCA for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home with Coram. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month (see Table 2).

Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury

At present, no plan to share individual participant data.

Highest detected lab values will be summarized between baseline and end of study participation.

lab values will be summarized at baseline and as change from baseline to worst follow-up value.

The number of patients reporting or experiencing adverse effects will be reported.

Lab values will be summarized at b aselin4e and as change from baseline to worst follow-up value.

Laboratory values will be summarized at baseline and as change from baseline to worst follow-up value

Midwestern Regional Medical Center

Lead National Medical Director, National Director Gastroenterology, Nutrition & Metabolic Support

This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks.

Omegaven: initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month.

Omegaven (Compassionate Use)

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Director of Clinical Trials

Maximum Conjugated Bilirubin

Baseline

4 Week Nadir

Average Improvement in Alkaline Phosphatase

Average Change in Alkaline Phosphatase

Number of Patients Experiencing Adverse Events

4 Weeks Nadir

Average Improvement in AST

Average Improvement in ALT

Overall Study

Anti-Infective Agents

All Drugs and Chemicals

Carbamide Peroxide

Patients randomized to receive oral citrulline at 3.8 gm/m2 in split BID dosing

Patients randomized to receive oral diluent for citrulline in BID dosing

Oral provision of amino acid citrulline to support impaired urea cycle function during escalated dose chemotherapy for stem cell transplant

Citrulline

Placebo

Brian W. Christman, MD

Patients undergoing bone marrow transplantation (BMT) and peripheral blood stem cell transplants (PBSCT) frequently develop organ dysfunctions, much of which may be initiated by damage to the liver and to cells lining blood vessels.

We, the researchers at Vanderbilt University, propose to perform a randomized, prospective, double-blind, placebo-controlled study of 144 patients undergoing allogeneic marrow transplantation. The treatment is aimed at supporting hepatic urea cycle function in patients receiving escalated dose chemotherapy/BMT. By so doing we hope to prevent development of hepatic venoocclusive disease (HVOD) and acute lung injury (ALI), two morbid complications of BMT. Patients will be randomized to receive oral citrulline, a urea cycle amino acid intermediate, or placebo beginning before conditioning therapy and continuing until 21 days after BMT. All patients will be followed for 100 days after study enrollment with intensive data collection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury	NCT01325584	Cancer Hepatic Injury	Omegaven	18 Years - 80 Years	Midwestern Regional Medical Center
Chemotherapy Toxicity Reduction Via Urea Cycle Support	NCT00223730	Cancer	Citrulline Placebo	13 Years - 65 Years	Vanderbilt University
Chemotherapy Toxicity Reduction Via Urea Cycle Support	NCT00223730	Cancer	Citrulline Placebo	13 Years - 65 Years	Vanderbilt University

Spots Global Cancer Trial Database for hepatic injury