Utility of Sodium Lactate Infusion During Septic Shock (ULIS1)

U

University Hospital, Lille

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Septic Shock

Treatments

Drug: Normal saline
Drug: Sodium Lactate light dose
Drug: Sodium Lactate high dose

Study type

Interventional

Funder types

Other

Identifiers

NCT03528213
2015_56
2017-002393-39 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 3 patient groups

Normal saline
Sham Comparator group
Description:
at physician discretion
Treatment:
Drug: Normal saline
Sodium lactate light dose
Experimental group
Description:
bolus 2.5ml/kg lactate 60min then 0.25ml/kg/h during 24hrs
Treatment:
Drug: Sodium Lactate light dose
Sodium lactate high dose
Experimental group
Description:
bolus 2.5ml/kg lactate 60min then 0.50ml/kg/h during 24hrs
Treatment:
Drug: Sodium Lactate high dose

Trial contacts and locations

7

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Central trial contact

Raphaël Favory, MD,PhD

Data sourced from clinicaltrials.gov

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