NCT03528213

Utility of Sodium Lactate Infusion During Septic Shock

Utility of Sodium Lactate Infusion During Septic Shock: Pilot Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Septic Shock

Interventions

Type	Name	Description
DRUG	Sodium Lactate light dose	bolus 2.5ml/kg then 0.25ml/kg/h
DRUG	Sodium Lactate high dose	bolus 2.5ml/kg then 0.5ml/kg/h
DRUG	Normal saline	normal saline at physician discretion

Timeline

• Start date: 2019-10-04
• Primary completion: 2023-02-21
• Completion: 2023-02-21
• First posted: 2018-05-17
• Last updated: 2025-12-11

Locations

7 sites across 1 country: France