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Lipid Emulsion

SMOFlipid for Malnutrition

Phase 4

Waitlist Available

Led By Jeffrey Rudolph, MD

Research Sponsored by Fresenius Kabi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who receive 80% or more of their total energy requirements as PN at enrollment and who are expected to receive 80% or more of their total energy requirements as PN for at least 56 days

Patients who require PN for at least 5 days/week

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of treatment until after end of last study pn duration of treatment: study treatment will last for a minimum of 8 weeks (56 consecutive days) and as long as pn is indicated, up to 1 year (365 consecutive days).

Awards & highlights

Study Summary

This trial looks at risk of fat & protein deficiency in patients on long-term parenteral nutrition.

Who is the study for?

This trial is for male or female patients, at least 1 month old, who need parenteral nutrition (PN) for most of their energy needs and expect to continue needing it for over 8 weeks. It's not suitable for those with certain liver issues, blood disorders, severe infections or renal failure, pregnant or breastfeeding women, participants in other trials, recent users of different lipid emulsions, or people allergic to fish, egg, soybean or peanut proteins.Check my eligibility

What is being tested?

The study tests SMOFlipid®, a type of fat given through the veins (lipid injectable emulsion), to see if it prevents essential fatty acid deficiency (EFAD) and parenteral nutrition-associated cholestasis (PNAC) in patients who rely on PN as their main source of nutrients.See study design

What are the potential side effects?

Potential side effects may include reactions related to infusion such as discomfort at the injection site or allergic reactions due to protein sensitivities. Since SMOFlipid® affects fat metabolism and liver function there could be changes in blood lipids levels and liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I get most of my nutrition through IV and will continue to do so for the next 56 days.

Select...

I need parenteral nutrition for at least 5 days a week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of treatment until after end of last study pn (+6 months for pediatric patients). study treatment will last for a minimum of 8 weeks (56 consecutive days) and as long as pn is indicated, up to 1 year (365 consecutive days).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of treatment until after end of last study pn (+6 months for pediatric patients). study treatment will last for a minimum of 8 weeks (56 consecutive days) and as long as pn is indicated, up to 1 year (365 consecutive days).

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of treatment until after end of last study pn (+6 months for pediatric patients). study treatment will last for a minimum of 8 weeks (56 consecutive days) and as long as pn is indicated, up to 1 year (365 consecutive days). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fatty acids

Incidence of EFAD

Incidence of PNAC

+2 more

Secondary outcome measures

BMI

Incidence of adverse events

Laboratory values hematology Hematocrit

+18 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single arm SMOFlipid® (lipid injectable emulsion)Experimental Treatment1 Intervention

Investigational drug: SMOFlipid® (lipid injectable emulsion).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fresenius KabiLead Sponsor

80 Previous Clinical Trials

1,137,268 Total Patients Enrolled

14 Trials studying Malnutrition

2,195 Patients Enrolled for Malnutrition

Jeffrey Rudolph, MDPrincipal InvestigatorUniversity of Pittsburgh

1 Previous Clinical Trials

1 Total Patients Enrolled

1 Trials studying Malnutrition

1 Patients Enrolled for Malnutrition

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research initiative have an age limit for participating patients?

"The criteria for participation in this trial is that applicants must be between 1 Month and 17 Years old. In total, there are 67 clinical trials targeting minors while 86 focus on seniors."

Answered by AI

Is it possible for me to participate in this research study?

"To qualify for this medical study, participants must display signs of malnutrition and be between 1 month and 17 years old. The trial is currently seeking 100 persons to take part in the experiment."

Answered by AI

Has the FDA given its approval of Single arm SMOFlipid® (lipid injectable emulsion)?

"As this is a Phase 4 trial, meaning Single arm SMOFlipid® (lipid injectable emulsion) has been authorized for use, the safety was rated 3 on our team's scale."

Answered by AI

Are there any remaining opportunities for participants to join this clinical investigation?

"Reviewing the information on clinicaltrials.gov, one can ascertain that this particular trial is not currently recruiting patients. The study was initiated on September 1st 2023 and its last update came 18 days later. At present time, there are 152 other medical trials actively seeking out participants to enrol in their studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

2024. "Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06049680.