Sepsis, SeverePhase 1/2LIPIDS-PNCT03405870

LIPIDS-P Trial Phase I/II Trial

A Phase 1/2 study testing Smoflipid in people with Sepsis, Severe and Septic Shock, run by University of Florida at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sepsis, Severe, Septic Shock
What is being tested?: Smoflipid
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 3 sitesUnited States
Study dates: 17 Aug 2018to 26 Apr 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

total bilirubin > 2 mg/dL,
serum albumin < 1.5 mg/dL,
hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients,
severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides > 400 mg/dL,
alternative/confounding diagnosis causing shock or critical illness (e.g., myocardial infarction or pulmonary embolus, massive hemorrhage, trauma),
significant traumatic brain injury (evidence of neurologic injury on CT scan and a GCS <8),

Show all 18Show fewer

refractory shock (likely death within 12 hours),
established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable,
anticipated requirement for surgery that would interfere with drug infusion,
severe primary blood coagulation disorder,
acute pancreatitis accompanied by hyperlipidemia,
acute thromboembolic disease,
uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel),
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),
pregnancy or lactation
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.
Child Pugh Class B/C liver disease patients or liver transplant recipient
Patients on, or anticipated to be placed on, ECMO within 48 hours of enrollment

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Department of Emergency Medicine, UF Health
Gainesville, Florida, 32610
UF Health Emergency Medicine
Gainesville, Florida, 32610
UF Health Jacksonville North campus
Jacksonville, Florida, 32218

Other trials in United States

About this study

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

Read the detailed description

Sepsis is a life-threatening disease for which there are no effective treatments. It results from metabolic and immunologic derangements that lead to organ dysfunction, shock and sometimes death. Both "good" (high density lipoprotein, HDL) and "bad" (low density lipoprotein, LDL) cholesterol should be protective against sepsis by helping to clear bacterial toxins from the blood stream and by providing a fuel for endogenous corticosteroids, part of the body's protective stress-response in shock. However, for partially unknown reasons, cholesterol levels drop to critically low levels in early sepsis, leaving the body unable to protect itself against sepsis via these mechanisms. Currently, lipid emulsions are available that are FDA approved for intravenous nutrition in critically ill patients (including sepsis) and may be capable of elevating serum cholesterol levels. This Phase II randomized pilot clinical trial, proposes to assess the following in a cohort of patients with early sepsis (first 24 hours): 1) safety and tolerability of the proposed lipid injectable emulsion (Smoflipid) and any adverse effects, 2) the drugs ability to optimally elevate cholesterol at 48 hours, and 3) preliminary measures of biological activity and clinical outcomes.

Conditions: Sepsis, Severe, Septic Shock
Being tested: Smoflipid
Keywords: cholesterol, lipids, total parenteral nutrition
Medical subject headings: Sepsis, Shock, Septic, Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SmoflipidDrug
Also called Total parenteral nutrition
Administration of lipid injectable emulsion

Study groups in NCT03405870
Study group	Role	What they receive
Phase II - 1.2 g/kg Smoflipid	Experimental	Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Receives: Drug: Smoflipid
Phase II - 1.4 g/kg Smoflipid	Experimental	Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Receives: Drug: Smoflipid
Phase II - 1.6 g/kg Smoflipid	Experimental	Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Receives: Drug: Smoflipid
Phase II - Control	No intervention	No drug, patients will be followed as active controls
Phase I - 1.0 g/kg Smoflipid	Experimental	Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Receives: Drug: Smoflipid
Phase I - 1.2 g/kg Smoflipid	Experimental	Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Receives: Drug: Smoflipid
Phase I - 1.4 g/kg Smoflipid	Experimental	Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Receives: Drug: Smoflipid
Phase I - 1.6 g/kg Smoflipid	Experimental	Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Receives: Drug: Smoflipid

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase II - Primary Outcome - Change in Total Cholesterol (48 Hours - Enrollment)
Change in total cholesterol (48 hour - enrollment value) of 0 to +5 mg/dL
Measured: 48 hours
Phase I - Primary Outcome - Maximum Tolerated Dose/Participants Experiencing Dose Related Toxicity
Using sequential dose escalation, participants received 2 doses of 1.0 to 1.6 g/kg of lipid emulsion (Smoflipid 20% lipid emulsion) within 48 hours of enrollment to test the maximum tolerated dose of study drug. The maximum tolerated dose was defined by patients exhibiting specific dose-related toxicities from administration of escalating doses of the study drug. Of 9 patients, adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of these were classified as dose limiting or serious.
Measured: First 48 hours

Secondary outcomes (1)

Phase II - Secondary Outcome - Organ Dysfunction
Sequential Organ Failure Assessment (SOFA) Score, this is a numerical score ranging from 0 to 24. A Higher SOFA score represents worsening organ dysfunction is correlated with higher rate of mortality. We measured the change over 48 hours.
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Aug 201826 Apr 2023

First posted23 Jan 2018
Study start17 Aug 2018
Primary completion26 Apr 2023
Study completion26 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Sepsis, SevereStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The study has a Phase I/II design. For the Phase I study, 10 patients were enrolled, and 9 completed the study. The Phase I study was designed to test the maximum tolerated dose of Smoflipid in escalating doses from 1.0 g/kg, 1.2 g/kg, 1.4 g/kg, and 1.6 g/kg. One patient withdrew from the study for social reasons. The Phase II trial was a randomized clinical trial to test the efficacy of 3 doses of study drug (1.2 g/kg, 1.4 g/kg, and 1.6 g/kg) for the primary outcome of cholesterol stabilization at 48 hours. 49 patients were enrolled and randomized. Two patients were withdrawn prior to drug. 47 patients completed the study protocol. Trial patients were randomized to receive either Smoflipid or control (no active treatment) using a Bayesian Optimal Interval Design. Thus, the Phase II arm included 24 patients in the control arm and 23 patients randomized to one of the three most efficacious doses of the study drug based on body weight, while the control group received no drug.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03405870
Sponsor's protocol ID: IRB201800027 - A
Other IDs: OCR19642
Acronym: LIPIDS-P
Status last verified: Feb 2025
First submitted: 12 Jan 2018
Last updated: 11 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Augustin B, Wu D, Black LP, Bertrand A, Sulaiman D, Hopson C, Jacob V, Shavit JA, Hofmaenner DA, Labilloy G, Smith L, Cagmat E, Graim K, Datta S, Reddy ST, Guirgis FW. Multiomic molecular patterns of lipid dysregulation in a subphenotype of sepsis with higher shock incidence and mortality. Crit Care. 2024 Dec 24;28(1):431. doi: 10.1186/s13054-024-05216-3.
PubMed 39716214
Guirgis FW, Black LP, Henson M, Bertrand A, DeVos E, Ferreira J, Gao H, Wu SS, Leeuwenburgh C, Moldawer L, Moore F, Reddy ST. The Lipid Intensive Drug Therapy for Sepsis Phase II Pilot Clinical Trial. Crit Care Med. 2024 Aug 1;52(8):1183-1193. doi: 10.1097/CCM.0000000000006268. Epub 2024 Mar 15.
PubMed 38488429
Guirgis FW, Black LP, DeVos E, Henson M, Ferreira J, Miller T, Rosenthal M, Leeuwenburgh C, Kalynych C, Moldawer L, Jones L, Crandall M, Reddy ST, Gao H, Wu S, Moore F. Lipid intensive drug therapy for sepsis pilot: A Bayesian phase I clinical trial. J Am Coll Emerg Physicians Open. 2020 Nov 18;1(6):1332-1340. doi: 10.1002/emp2.12237. eCollection 2020 Dec.
PubMed 33392541
Guirgis FW, Black LP, Rosenthal MD, Henson M, Ferreira J, Leeuwenburgh C, Kalynych C, Moldawer LL, Miller T, Jones L, Crandall M, Reddy ST, Wu SS, Moore FA. LIPid Intensive Drug therapy for Sepsis Pilot (LIPIDS-P): Phase I/II clinical trial protocol of lipid emulsion therapy for stabilising cholesterol levels in sepsis and septic shock. BMJ Open. 2019 Sep 18;9(9):e029348. doi: 10.1136/bmjopen-2019-029348.
PubMed 31537565

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The LIPid Intensive Drug Therapy for Sepsis ¬Pilot (LIPIDS-P) Phase I/II Trial
ClinicalTrials.gov ID: NCT03405870
Acronym / sponsor ID: LIPIDS-P / IRB201800027 - A
Conditions: Sepsis, Severe, Septic Shock
Keywords: cholesterol, lipids, total parenteral nutrition
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Study start: 17 Aug 2018 (actual)
Primary completion: 26 Apr 2023 (actual)
Study completion: 26 Apr 2023 (actual)
First posted: 23 Jan 2018 (actual)
Results: Posted 11 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 8
Model description: The study has a Phase I/II design. For the Phase I study, 10 patients were enrolled, and 9 completed the study. The Phase I study was designed to test the maximum tolerated dose of Smoflipid in escalating doses from 1.0 g/kg, 1.2 g/kg, 1.4 g/kg, and 1.6 g/kg. One patient withdrew from the study for social reasons. The Phase II trial was a randomized clinical trial to test the efficacy of 3 doses of study drug (1.2 g/kg, 1.4 g/kg, and 1.6 g/kg) for the primary outcome of cholesterol stabilization at 48 hours. 49 patients were enrolled and randomized. Two patients were withdrawn prior to drug. 47 patients completed the study protocol. Trial patients were randomized to receive either Smoflipid or control (no active treatment) using a Bayesian Optimal Interval Design. Thus, the Phase II arm included 24 patients in the control arm and 23 patients randomized to one of the three most efficacious doses of the study drug based on body weight, while the control group received no drug.

Arm	Type	Receives
Phase II - 1.2 g/kg Smoflipid	Experimental	Drug: SmoflipidInfusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment.
Phase II - 1.4 g/kg Smoflipid	Experimental	Drug: SmoflipidInfusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment.
Phase II - 1.6 g/kg Smoflipid	Experimental	Drug: SmoflipidInfusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment.
Phase II - Control	No intervention	–No drug, patients will be followed as active controls
Phase I - 1.0 g/kg Smoflipid	Experimental	Drug: SmoflipidInfusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment.
Phase I - 1.2 g/kg Smoflipid	Experimental	Drug: SmoflipidInfusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment.
Phase I - 1.4 g/kg Smoflipid	Experimental	Drug: SmoflipidInfusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment.
Phase I - 1.6 g/kg Smoflipid	Experimental	Drug: SmoflipidInfusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (18 listed)

total bilirubin > 2 mg/dL,
serum albumin < 1.5 mg/dL,
hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients,
severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides > 400 mg/dL,
alternative/confounding diagnosis causing shock or critical illness (e.g., myocardial infarction or pulmonary embolus, massive hemorrhage, trauma),

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SmoflipidAlso: Total parenteral nutritionAdministration of lipid injectable emulsion	Drug	Phase I - 1.0 g/kg Smoflipid, Phase I - 1.2 g/kg Smoflipid, Phase I - 1.4 g/kg Smoflipid, Phase I - 1.6 g/kg Smoflipid, Phase II - 1.2 g/kg Smoflipid, Phase II - 1.4 g/kg Smoflipid, Phase II - 1.6 g/kg Smoflipid

Primary outcome

Phase II - Primary Outcome - Change in Total Cholesterol (48 Hours - Enrollment)
Time frame: 48 hours
Change in total cholesterol (48 hour - enrollment value) of 0 to +5 mg/dL
Phase I - Primary Outcome - Maximum Tolerated Dose/Participants Experiencing Dose Related Toxicity
Time frame: First 48 hours
Using sequential dose escalation, participants received 2 doses of 1.0 to 1.6 g/kg of lipid emulsion (Smoflipid 20% lipid emulsion) within 48 hours of enrollment to test the maximum tolerated dose of study drug. The maximum tolerated dose was defined by patients exhibiting specific dose-related toxicities from administration of escalating doses of the study drug. Of 9 patients, adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of these were classified as dose limiting or serious.

1 secondary outcome

Phase II - Secondary Outcome - Organ Dysfunction
Time frame: 48 hours

Results and safety

Results posted to the registry on 11 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase II - 1.2 g/kg Smoflipid	11	10
Phase II - 1.4 g/kg Smoflipid	4	4
Phase II - 1.6 g/kg Smoflipid	10	9
Phase II - Control	24	24
Phase I - 1.0 g/kg Smoflipid	2	2
Phase I - 1.2 g/kg Smoflipid	2	2
Phase I - 1.4 g/kg Smoflipid	3	2
Phase I - 1.6 g/kg Smoflipid	3	3

Primary outcome: Phase II - Primary Outcome - Change in Total Cholesterol (48 Hours - Enrollment)

Time frame: 48 hours. Mean (Standard Deviation). Unit: mg/dL

Measure	Phase II - 1.2 g/kg Smoflipid n = 10	Phase II - 1.4 g/kg Smoflipid n = 4	Phase II - 1.6 g/kg Smoflipid n = 9	Phase II - Control n = 24	Phase I - 1.0 g/kg Smoflipid n = 2	Phase I - 1.2 g/kg Smoflipid n = 2	Phase I - 1.4 g/kg Smoflipid n = 2	Phase I - 1.6 g/kg Smoflipid n = 3
Value	9 (17)	-10 (29)	4 (21)	2 (18)	-12 (23)	16 (1)	-9 (10)	-18 (9)

Population analysed: Phase II participants were analyzed for the primary outcome of change in total cholesterol at 48 hours (47 patients) at doses of 1.2, 1.4 and 1.6 g/kg. Phase I participants were also analyzed for this outcome, although it was not the primary outcome for this phase (which was maximum tolerated dose).

Primary outcome: Phase I - Primary Outcome - Maximum Tolerated Dose/Participants Experiencing Dose Related Toxicity

Time frame: First 48 hours. Count of participants. Unit: Participants

Measure	Phase II - 1.2 g/kg Smoflipid n = 0	Phase II - 1.4 g/kg Smoflipid n = 0	Phase II - 1.6 g/kg Smoflipid n = 0	Phase II - Control n = 0	Phase I - 1.0 g/kg Smoflipid n = 2	Phase I - 1.2 g/kg Smoflipid n = 2	Phase I - 1.4 g/kg Smoflipid n = 2	Phase I - 1.6 g/kg Smoflipid n = 3
Value	0	0	0	0	0	0	0	0

Phase I - 1.0 g/kg Smoflipid vs Phase I - 1.2 g/kg Smoflipid vs Phase I - 1.4 g/kg Smoflipid vs Phase I - 1.6 g/kg Smoflipid: Value of Maximum Tolerated Dose (g/kg): 1.6

Population analysed: Only Phase I trial patients were analyzed for this component of the study.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected from enrollment through 28 days after enrollment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase II - 1.2 g/kg Smoflipid	2 of 10 (20%)	6 of 10 (60%)	1 of 10
Phase II - 1.4 g/kg Smoflipid	3 of 4 (75%)	3 of 4 (75%)	3 of 4
Phase II - 1.6 g/kg Smoflipid	1 of 9 (11.1%)	7 of 9 (77.8%)	0 of 9
Phase II - Control	8 of 24 (33.3%)	8 of 24 (33.3%)	7 of 24
Phase I - 1.0 g/kg Smoflipid	2 of 2 (100%)	2 of 2 (100%)	1 of 2
Phase I - 1.2 g/kg Smoflipid	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Phase I - 1.4 g/kg Smoflipid	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Phase I - 1.6 g/kg Smoflipid	2 of 3 (66.7%)	2 of 3 (66.7%)	2 of 3

Limitations and caveats (from the sponsor): For the Phase I trial, the main limitation was the small sample of patients; however, this is not uncommon among phase I trials. The Phase II was also a small clinical trial of 47 patients, planned for 24 patients in each arm. Strict enrollment criteria limited enrollment in this study and the exclusion of patients with elevated bilirubin given the drug's hepatic metabolism and risk of complications limited the number of patients who could enroll.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39716214Augustin B, Wu D, Black LP, Bertrand A, Sulaiman D, Hopson C, Jacob V, Shavit JA, Hofmaenner DA, Labilloy G, Smith L, Cagmat E, Graim K, Datta S, Reddy ST, Guirgis FW. Multiomic molecular patterns of lipid dysregulation in a subphenotype of sepsis with higher shock incidence and mortality. Crit Care. 2024 Dec 24;28(1):431. doi: 10.1186/s13054-024-05216-3.
Derived from this study: PubMed 38488429Guirgis FW, Black LP, Henson M, Bertrand A, DeVos E, Ferreira J, Gao H, Wu SS, Leeuwenburgh C, Moldawer L, Moore F, Reddy ST. The Lipid Intensive Drug Therapy for Sepsis Phase II Pilot Clinical Trial. Crit Care Med. 2024 Aug 1;52(8):1183-1193. doi: 10.1097/CCM.0000000000006268. Epub 2024 Mar 15.
Derived from this study: PubMed 33392541Guirgis FW, Black LP, DeVos E, Henson M, Ferreira J, Miller T, Rosenthal M, Leeuwenburgh C, Kalynych C, Moldawer L, Jones L, Crandall M, Reddy ST, Gao H, Wu S, Moore F. Lipid intensive drug therapy for sepsis pilot: A Bayesian phase I clinical trial. J Am Coll Emerg Physicians Open. 2020 Nov 18;1(6):1332-1340. doi: 10.1002/emp2.12237. eCollection 2020 Dec.
Derived from this study: PubMed 31537565Guirgis FW, Black LP, Rosenthal MD, Henson M, Ferreira J, Leeuwenburgh C, Kalynych C, Moldawer LL, Miller T, Jones L, Crandall M, Reddy ST, Wu SS, Moore FA. LIPid Intensive Drug therapy for Sepsis Pilot (LIPIDS-P): Phase I/II clinical trial protocol of lipid emulsion therapy for stabilising cholesterol levels in sepsis and septic shock. BMJ Open. 2019 Sep 18;9(9):e029348. doi: 10.1136/bmjopen-2019-029348.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Faheem W Guirgis, MD principal investigator

University of Florida

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Smoflipid in people with Sepsis, Severe and Septic Shock, run by University of Florida at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase II - Primary Outcome - Change in Total Cholesterol (48 Hours - Enrollment) (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03405870, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.