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Completed

NCT Number: NCT03528213

Utility of Sodium Lactate Infusion During Septic Shock

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CH ARRAS, Arras, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Lactate light dose

Drug

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

Sodium Lactate high dose

Drug

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

normal saline

Drug

normal saline at physician discretion

Primary outcomes

  1. fluid balance

    Time frame: at 48 hours

    fluid balance

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Utility of Sodium Lactate Infusion During Septic Shock: Pilot Study

Acronym: ULIS1

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 17, 2018
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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