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Utility of Sodium Lactate Infusion During Septic Shock (ULIS1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528213
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Sodium Lactate light dose Drug: Sodium Lactate high dose Drug: Normal saline Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: bolus then continuous infusion of molar sodium lactate (2 doses) or normal saline
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Utility of Sodium Lactate Infusion During Septic Shock: Pilot Study
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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




Primary Outcome Measures :
  1. fluid balance [ Time Frame: at 48 hours ]
    fluid balance


Secondary Outcome Measures :
  1. fluid balance at day 7 [ Time Frame: Day 7 ]
  2. SOFA (Sequential Organ Failure Assessment) [ Time Frame: Day 1, Day 2, Day 3, Day 7 ]
  3. death in Intensive Care Unit (ICU) [ Time Frame: Day 90 ]
  4. number of patients dead [ Time Frame: Day 28 ]
  5. death in hospital [ Time Frame: Day 90 ]
  6. catecholamines free days [ Time Frame: Day 28 ]
  7. ventilator free days [ Time Frame: Day 28 ]
  8. renal replacement therapy free days [ Time Frame: Day 28 ]
  9. new kidney failure [ Time Frame: Day 28 ]
  10. nosocomial infections [ Time Frame: day 90 ]
  11. hypernatremia [ Time Frame: Day 2 ]
  12. hypokaliemia [ Time Frame: Day 2 ]
  13. metabolic alkalosis [ Time Frame: day 2 ]
  14. hemodynamic effects assessed by the PICCO® monitoring system [ Time Frame: at 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • septic shock (sepsis 3 definition)
  • need to fluid administration <6hrs of norepinephrine introduction
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528213


Contacts
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Contact: Raphaël Favory, MD,PhD 03 20 44 54 94 ext +33 raphael.favory@chru-lille.fr

Locations
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France
CH ARRAS Recruiting
Arras, France
Principal Investigator: Maxime GRANIER, MD         
CH DOUAI Recruiting
Douai, France
Principal Investigator: Benjamin KOWALSKI, MD         
CH LENS Recruiting
Lens, France
Principal Investigator: Didier THEVENIN, MD         
Hôpital Roger Salengro, CHU Recruiting
Lille, France
Principal Investigator: Raphael Favory, MD,PhD         
Hopital Victor Provo - Roubaix Recruiting
Roubaix, France
Principal Investigator: clément VANBAELINGHEM, MD         
Chu Rouen Recruiting
Rouen, France
Principal Investigator: Fabienne TAMION, MD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Raphaël Favory, MD,PhD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03528213    
Other Study ID Numbers: 2015_56
2017-002393-39 ( EudraCT Number )
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
sepsis
fluid balance
metabolism
ischemia-reperfusion
treatment
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation