Utility of Sodium Lactate Infusion During Septic Shock | NCT03528213

Studies
Utility of Sodium Lactate Infusion During Septic Shock

NCT03528213

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Dec 11, 2025Actual

Enrollment

59Actual

Phase

Phase 2Phase 3

Conditions

Septic Shock

Interventions

Sodium Lactate light dose
Sodium Lactate high dose
Normal saline

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2017-002393-39	EudraCT Number

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 4, 2019Actual

Primary Completion Date

Feb 21, 2023Actual

Completion Date

Feb 21, 2023Actual

First Submitted Date

May 3, 2018

First Submission Date that Met QC Criteria

May 16, 2018

First Posted Date

May 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2025

Last Update Posted Date

Dec 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal saline	Sham Comparator	at physician discretion	Drug: Normal saline
Sodium lactate light dose	Experimental	bolus 2.5ml/kg lactate 60min then 0.25ml/kg/h during 24hrs	Drug: Sodium Lactate light dose
Sodium lactate high dose	Experimental	bolus 2.5ml/kg lactate 60min then 0.50ml/kg/h during 24hrs	Drug: Sodium Lactate high dose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sodium Lactate light dose	Drug	bolus 2.5ml/kg then 0.25ml/kg/h	Sodium lactate light dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fluid balance	fluid balance	at 48 hours

Secondary Outcomes

Measure	Description	Time Frame
fluid balance at day 7		Day 7
SOFA (Sequential Organ Failure Assessment)		Day 1, Day 2, Day 3, Day 7
death in Intensive Care Unit (ICU)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raphaël Favory, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CH ARRAS		Arras			France
CH DOUAI

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012772	Shock, Septic
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019354	Sodium Lactate
D000077330	Saline Solution

Ancestor Terms

ID	Term
D007773	Lactates
D006880	Hydroxy Acids
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided