Septic ShockPhase 2/3ULIS1NCT03528213
Utility of Sodium Lactate Infusion During Septic Shock
A Phase 2/3 study testing Sodium Lactate light dose, Sodium Lactate high dose and Normal saline in people with Septic Shock, run by University Hospital, Lille at 7 sites in France.
Trial summary
ULIS-1 is an open-label pilot study concerning utility of molar sodium lactate in fluid balance in septic shock patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Sodium Lactate light dose, Sodium Lactate high dose and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 7 sitesFrance
- Study dates
- 4 Oct 2019to 21 Feb 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- Presence of septic shock
- requiring vascular filling within 12 hours after introduction of Noradrenaline. Septic shock is defined as sepsis with persistent hypotension requiring the administration of vasopressors to maintain RTE > 65mmHg.
- social insurance
Who cannot join
- pregnancy
- cardiac arrest
- more than 50ml/kg of fluid loading
- chronic renal failure with chronic hemodialysis or the investigators estimate a need for renal replacement therapy in the following 24hrs
- child C or acute liver failure with PT<40% (unless AVK)
- plasmatic sodium <120 or >145mmol/l
- metabolic alkalosis with pH>7.45
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CH ARRAS
Arras
CH DOUAI
Douai
Ch Dunkerque
Dunkirk
CH LENS
Lens
Hôpital Roger Salengro, CHU
Lille
Hopital Victor Provo - Roubaix
Roubaix
Chu Rouen
Rouen
About this study
Official title: Utility of Sodium Lactate Infusion During Septic Shock: Pilot Study
ULIS-1 is an open-label pilot study concerning utility of molar sodium lactate in fluid balance in septic shock patients
Read the detailed description
ULIS-1 consists in three arms of treatment during the first 24hrs of septic shock treatment.
- normal saline
- sodium lactate 2.5ml/kg in 60min then
- either 0.25 or 0.5ml/kg/h during 24hrs Main criteria is fluid balance at 48hrs
- Conditions
- Septic Shock
- Being tested
- Sodium Lactate light dose, Sodium Lactate high dose, Normal saline
- Keywords
- sepsis, fluid balance, metabolism, ischemia-reperfusion, treatment
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Lactate light doseDrug
bolus 2.5ml/kg then 0.25ml/kg/h
Sodium Lactate high doseDrug
bolus 2.5ml/kg then 0.5ml/kg/h
Normal salineDrug
normal saline at physician discretion
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Sham comparator | at physician discretion Receives: Drug: Normal saline |
| Sodium lactate light dose | Experimental | bolus 2.5ml/kg lactate 60min then 0.25ml/kg/h during 24hrs Receives: Drug: Sodium Lactate light dose |
| Sodium lactate high dose | Experimental | bolus 2.5ml/kg lactate 60min then 0.50ml/kg/h during 24hrs Receives: Drug: Sodium Lactate high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid balance
fluid balance
Measured: at 48 hours
Secondary outcomes (14)
fluid balance at day 7
Measured: Day 7
SOFA (Sequential Organ Failure Assessment)
Measured: Day 1, Day 2, Day 3, Day 7
death in Intensive Care Unit (ICU)
Measured: Day 90
number of patients dead
Measured: Day 28
death in hospital
Measured: Day 90
catecholamines free days
Measured: Day 28
ventilator free days
Measured: Day 28
renal replacement therapy free days
Measured: Day 28
new kidney failure
Measured: Day 28
nosocomial infections
Measured: day 90
hypernatremia
Measured: Day 2
hypokaliemia
Measured: Day 2
metabolic alkalosis
Measured: day 2
hemodynamic effects assessed by the PICCO® monitoring system
Measured: at 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start4 Oct 2019
- Primary completion21 Feb 2023
- Study completion21 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- bolus then continuous infusion of molar sodium lactate (2 doses) or normal saline
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphaël Favory, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528213
- Sponsor's protocol ID
- 2015_56
- Other IDs
- 2017-002393-39, 2017
- Acronym
- ULIS1
- Status last verified
- Dec 2025
- First submitted
- 3 May 2018
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Sodium Lactate Infusion During Septic Shock: Pilot Study
- ClinicalTrials.gov ID
- NCT03528213
- Acronym / sponsor ID
- ULIS1 / 2015_56
- Conditions
- Septic Shock
- Keywords
- sepsis, fluid balance, metabolism, ischemia-reperfusion, treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ULIS-1 is an open-label pilot study concerning utility of molar sodium lactate in fluid balance in septic shock patients
Detailed description
ULIS-1 consists in three arms of treatment during the first 24hrs of septic shock treatment.
- normal saline
- sodium lactate 2.5ml/kg in 60min then
- either 0.25 or 0.5ml/kg/h during 24hrs Main criteria is fluid balance at 48hrs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- bolus then continuous infusion of molar sodium lactate (2 doses) or normal saline
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Sham comparator | Drug: Normal salineat physician discretion |
| Sodium lactate light dose | Experimental | Drug: Sodium Lactate light dosebolus 2.5ml/kg lactate 60min then 0.25ml/kg/h during 24hrs |
| Sodium lactate high dose | Experimental | Drug: Sodium Lactate high dosebolus 2.5ml/kg lactate 60min then 0.50ml/kg/h during 24hrs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of septic shock
- requiring vascular filling within 12 hours after introduction of Noradrenaline. Septic shock is defined as sepsis with persistent hypotension requiring the administration of vasopressors to maintain RTE > 65mmHg.
- social insurance
Key exclusion criteria (7 listed)
- pregnancy
- cardiac arrest
- more than 50ml/kg of fluid loading
- chronic renal failure with chronic hemodialysis or the investigators estimate a need for renal replacement therapy in the following 24hrs
- child C or acute liver failure with PT<40% (unless AVK)
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 |
|---|---|---|
| Sodium Lactate light dosebolus 2.5ml/kg then 0.25ml/kg/h | Drug | Sodium lactate light dose |
| Sodium Lactate high dosebolus 2.5ml/kg then 0.5ml/kg/h | Drug | Sodium lactate high dose |
| Normal salinenormal saline at physician discretion | Drug | Normal saline |
Primary outcome
fluid balance
Time frame: at 48 hours
fluid balance
14 secondary outcomes
fluid balance at day 7
Time frame: Day 7
SOFA (Sequential Organ Failure Assessment)
Time frame: Day 1, Day 2, Day 3, Day 7
death in Intensive Care Unit (ICU)
Time frame: Day 90
number of patients dead
Time frame: Day 28
death in hospital
Time frame: Day 90
catecholamines free days
Time frame: Day 28
ventilator free days
Time frame: Day 28
renal replacement therapy free days
Time frame: Day 28
new kidney failure
Time frame: Day 28
nosocomial infections
Time frame: day 90
hypernatremia
Time frame: Day 2
hypokaliemia
Time frame: Day 2
metabolic alkalosis
Time frame: day 2
hemodynamic effects assessed by the PICCO® monitoring system
Time frame: at 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
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.
Raphaël Favory, MD,PhD principal investigator
University Hospital, Lille
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sodium Lactate light dose, Sodium Lactate high dose and Normal saline in people with Septic Shock, run by University Hospital, Lille at 7 sites in France.
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 3 inclusion and 7 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 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
fluid balance (time frame: at 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.