Utility of Sodium Lactate Infusion During Septic Shock (ULIS1)

December 4, 2025 updated by: University Hospital, Lille

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Arras, France
        • CH Arras
      • Douai, France
        • CH DOUAI
      • Dunkirk, France
        • CH Dunkerque
      • Lens, France
        • CH Lens
      • Lille, France
        • Hôpital Roger Salengro, CHU
      • Roubaix, France
        • Hopital Victor Provo - Roubaix
      • Rouen, France
        • CHU Rouen

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.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Normal saline
at physician discretion
Drug: Normal saline
normal saline at physician discretion
Experimental: Sodium lactate light dose
bolus 2.5ml/kg lactate 60min then 0.25ml/kg/h during 24hrs
Drug: Sodium Lactate light dose
bolus 2.5ml/kg then 0.25ml/kg/h
Experimental: Sodium lactate high dose
bolus 2.5ml/kg lactate 60min then 0.50ml/kg/h during 24hrs
Drug: Sodium Lactate high dose
bolus 2.5ml/kg then 0.5ml/kg/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fluid balance
Time Frame: at 48 hours
fluid balance
at 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
fluid balance at day 7
Time Frame: Day 7
Day 7
SOFA (Sequential Organ Failure Assessment)
Time Frame: Day 1, Day 2, Day 3, Day 7
Day 1, Day 2, Day 3, Day 7
death in Intensive Care Unit (ICU)
Time Frame: Day 90
Day 90
number of patients dead
Time Frame: Day 28
Day 28
death in hospital
Time Frame: Day 90
Day 90
catecholamines free days
Time Frame: Day 28
Day 28
ventilator free days
Time Frame: Day 28
Day 28
renal replacement therapy free days
Time Frame: Day 28
Day 28
new kidney failure
Time Frame: Day 28
Day 28
nosocomial infections
Time Frame: day 90
day 90
hypernatremia
Time Frame: Day 2
Day 2
hypokaliemia
Time Frame: Day 2
Day 2
metabolic alkalosis
Time Frame: day 2
day 2
hemodynamic effects assessed by the PICCO® monitoring system
Time Frame: at 48 hours
at 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Raphaël Favory, MD,PhD, University Hospital, Lille

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 Major Dates

Study Start (Actual)

October 4, 2019

Primary Completion (Actual)

February 21, 2023

Study Completion (Actual)

February 21, 2023

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

May 16, 2018

First Posted (Actual)

May 17, 2018

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015_56
  • 2017-002393-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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