COMPLETED

LIPIDS-P Trial Phase I/II Trial

Conditions

Sepsis, Severe Septic Shock cholesterol lipids total parenteral nutrition

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Briefly, this pilot clinical trial will evaluate preliminary safety and efficacy of the study drug (Smoflipid) at elevating cholesterol levels (primary outcome) in patients with sepsis and moderate organ dysfunction and will also evaluate measures of organ dysfunction, mortality, and biological activity (secondary outcomes).

Official Title

The LIPid Intensive Drug Therapy for Sepsis ¬Pilot (LIPIDS-P) Phase I/II Trial

Quick Facts

Study Start:2018-08-17

Study Completion:2023-04-26

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03405870

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. age \> 18, 2. primary diagnosis of sepsis and within 24 hours of sepsis recognition and treated with institutional sepsis algorithm, 3. SOFA score ≥ 4, 4. screening total cholesterol ≤ 100 mg/dL or HDL-C + LDL-C ≤ 70 mg/dL	1. total bilirubin \> 2 mg/dL, 2. serum albumin \< 1.5 mg/dL, 3. hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients, 4. severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides \> 400 mg/dL, 5. alternative/confounding diagnosis causing shock or critical illness (e.g., myocardial infarction or pulmonary embolus, massive hemorrhage, trauma), 6. significant traumatic brain injury (evidence of neurologic injury on CT scan and a GCS \<8), 7. refractory shock (likely death within 12 hours), 8. established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable, 9. anticipated requirement for surgery that would interfere with drug infusion, 10. severe primary blood coagulation disorder, 11. acute pancreatitis accompanied by hyperlipidemia, 12. acute thromboembolic disease, 13. uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel), 14. severe immunocompromised state (e.g. subject has neutropenia receiving cytotoxic chemotherapy with absolute neutrophil count \< 500/ul or expected to decline to \< 500/uL within the next 3 days), 15. pregnancy or lactation 16. already receiving intravenous lipid formulations (e.g., TPN, propofol) will be excluded from the study as lipid infusion will interfere with interpretation of the study results. 17. Child Pugh Class B/C liver disease patients or liver transplant recipient 18. Patients on, or anticipated to be placed on, ECMO within 48 hours of enrollment

Inclusion Criteria

Exclusion Criteria

1. age \> 18,
2. primary diagnosis of sepsis and within 24 hours of sepsis recognition and treated with institutional sepsis algorithm,
3. SOFA score ≥ 4,
4. screening total cholesterol ≤ 100 mg/dL or HDL-C + LDL-C ≤ 70 mg/dL

1. total bilirubin \> 2 mg/dL,
2. serum albumin \< 1.5 mg/dL,
3. hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients,
4. severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides \> 400 mg/dL,
5. alternative/confounding diagnosis causing shock or critical illness (e.g., myocardial infarction or pulmonary embolus, massive hemorrhage, trauma),
6. significant traumatic brain injury (evidence of neurologic injury on CT scan and a GCS \<8),
7. refractory shock (likely death within 12 hours),
8. established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable,
9. anticipated requirement for surgery that would interfere with drug infusion,
10. severe primary blood coagulation disorder,
11. acute pancreatitis accompanied by hyperlipidemia,
12. acute thromboembolic disease,
13. uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel),
14. severe immunocompromised state (e.g. subject has neutropenia receiving cytotoxic chemotherapy with absolute neutrophil count \< 500/ul or expected to decline to \< 500/uL within the next 3 days),
15. pregnancy or lactation
16. already receiving intravenous lipid formulations (e.g., TPN, propofol) will be excluded from the study as lipid infusion will interfere with interpretation of the study results.
17. Child Pugh Class B/C liver disease patients or liver transplant recipient
18. Patients on, or anticipated to be placed on, ECMO within 48 hours of enrollment

Contacts and Locations

Principal Investigator

Faheem W Guirgis, MD

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

Department of Emergency Medicine, UF Health

Gainesville, Florida, 32610

United States

UF Health Emergency Medicine

Gainesville, Florida, 32610

United States

UF Health Jacksonville North campus

Jacksonville, Florida, 32218

United States

Collaborators and Investigators

Sponsor: University of Florida

Faheem W Guirgis, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-17

Study Completion Date2023-04-26

Study Record Updates

Study Start Date2018-08-17

Study Completion Date2023-04-26

Terms related to this study

Keywords Provided by Researchers

cholesterol
lipids
total parenteral nutrition

Additional Relevant MeSH Terms

Sepsis, Severe
Septic Shock