Utility of Sodium Lactate Infusion During Septic Shock

NCT03528213 | Completed Phase 2 DMC

• 2 other identifiers: 2015_562017-002393-39
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 7

Brief Summary

ULIS-1 is an open-label pilot study concerning utility of molar sodium lactate in fluid balance in septic shock patients

Conditions

Septic Shock

Keywords

sepsis; fluid balance; metabolism; ischemia-reperfusion; treatment

Outcome Measures

Primary Outcomes (1)

• fluid balance

  fluid balance

  at 48 hours

Secondary Outcomes (14)

• 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)

  Day 90

• number of patients dead

  Day 28

• death in hospital

  Day 90

Study Arms (3)

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

Sodium Lactate light dose DRUG

bolus 2.5ml/kg then 0.25ml/kg/h

Sodium lactate light dose

Sodium Lactate high dose DRUG

bolus 2.5ml/kg then 0.5ml/kg/h

Sodium lactate high dose

Normal saline DRUG

normal saline at physician discretion

Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (7)

CH ARRAS

Arras, France

Location

CH DOUAI

Douai, France

Location

Ch Dunkerque

Dunkirk, France

Location

CH LENS

Lens, France

Location

Hôpital Roger Salengro, CHU

Lille, France

Location

Hopital Victor Provo - Roubaix

Roubaix, France

Location

Chu Rouen

Rouen, France

Location

MeSH Terms

Conditions

Shock, Septic; Sepsis

Interventions

Sodium Lactate; Saline Solution

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Raphaël Favory, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: bolus then continuous infusion of molar sodium lactate (2 doses) or normal saline

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 17, 2018
• Study Start: October 4, 2019
• Primary Completion: February 21, 2023
• Study Completion: February 21, 2023
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

FR (7)