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Utility of Sodium Lactate Infusion During Septic Shock (ULIS1)

Primary Purpose

Septic Shock

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Sodium Lactate light dose
Sodium Lactate high dose
Normal saline
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring sepsis, fluid balance, metabolism, ischemia-reperfusion, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH ARRASRecruiting
  • CH DOUAIRecruiting
  • Ch DunkerqueRecruiting
  • CH LENSRecruiting
  • Hôpital Roger Salengro, CHURecruiting
  • Hopital Victor Provo - RoubaixRecruiting
  • Chu RouenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Normal saline

Sodium lactate light dose

Sodium lactate high dose

Arm Description

at physician discretion

bolus 2.5ml/kg lactate 60min then 0.25ml/kg/h during 24hrs

bolus 2.5ml/kg lactate 60min then 0.50ml/kg/h during 24hrs

Outcomes

Primary Outcome Measures

fluid balance
fluid balance

Secondary Outcome Measures

fluid balance at day 7
SOFA (Sequential Organ Failure Assessment)
death in Intensive Care Unit (ICU)
number of patients dead
death in hospital
catecholamines free days
ventilator free days
renal replacement therapy free days
new kidney failure
nosocomial infections
hypernatremia
hypokaliemia
metabolic alkalosis
hemodynamic effects assessed by the PICCO® monitoring system

Full Information

First Posted
May 3, 2018
Last Updated
August 16, 2022
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03528213
Brief Title
Utility of Sodium Lactate Infusion During Septic Shock
Acronym
ULIS1
Official Title
Utility of Sodium Lactate Infusion During Septic Shock: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
sepsis, fluid balance, metabolism, ischemia-reperfusion, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
bolus then continuous infusion of molar sodium lactate (2 doses) or normal saline
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal saline
Arm Type
Sham Comparator
Arm Description
at physician discretion
Arm Title
Sodium lactate light dose
Arm Type
Experimental
Arm Description
bolus 2.5ml/kg lactate 60min then 0.25ml/kg/h during 24hrs
Arm Title
Sodium lactate high dose
Arm Type
Experimental
Arm Description
bolus 2.5ml/kg lactate 60min then 0.50ml/kg/h during 24hrs
Intervention Type
Drug
Intervention Name(s)
Sodium Lactate light dose
Intervention Description
bolus 2.5ml/kg then 0.25ml/kg/h
Intervention Type
Drug
Intervention Name(s)
Sodium Lactate high dose
Intervention Description
bolus 2.5ml/kg then 0.5ml/kg/h
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
normal saline at physician discretion
Primary Outcome Measure Information:
Title
fluid balance
Description
fluid balance
Time Frame
at 48 hours
Secondary Outcome Measure Information:
Title
fluid balance at day 7
Time Frame
Day 7
Title
SOFA (Sequential Organ Failure Assessment)
Time Frame
Day 1, Day 2, Day 3, Day 7
Title
death in Intensive Care Unit (ICU)
Time Frame
Day 90
Title
number of patients dead
Time Frame
Day 28
Title
death in hospital
Time Frame
Day 90
Title
catecholamines free days
Time Frame
Day 28
Title
ventilator free days
Time Frame
Day 28
Title
renal replacement therapy free days
Time Frame
Day 28
Title
new kidney failure
Time Frame
Day 28
Title
nosocomial infections
Time Frame
day 90
Title
hypernatremia
Time Frame
Day 2
Title
hypokaliemia
Time Frame
Day 2
Title
metabolic alkalosis
Time Frame
day 2
Title
hemodynamic effects assessed by the PICCO® monitoring system
Time Frame
at 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raphaël Favory, MD,PhD
Phone
03 20 44 54 94
Ext
+33
Email
raphael.favory@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphaël Favory, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH ARRAS
City
Arras
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxime GRANIER, MD
Facility Name
CH DOUAI
City
Douai
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin KOWALSKI, MD
Facility Name
Ch Dunkerque
City
Dunkerque
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Varillon, MD
Facility Name
CH LENS
City
Lens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier THEVENIN, MD
Facility Name
Hôpital Roger Salengro, CHU
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphael Favory, MD,PhD
Facility Name
Hopital Victor Provo - Roubaix
City
Roubaix
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
clément VANBAELINGHEM, MD
Facility Name
Chu Rouen
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabienne TAMION, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Utility of Sodium Lactate Infusion During Septic Shock

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