Utility of Sodium Lactate Infusion During Septic Shock (ULIS1)

University Hospital, Lille

Status and phase: Completed; Phase 3; Phase 2

Conditions: Septic Shock

Treatments: Drug: Normal saline; Drug: Sodium Lactate high dose; Drug: Sodium Lactate light 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: 59 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)

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59 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