Utility of Sodium Lactate Infusion During Septic Shock

Septic Shock Clinical Trial

— ULIS1  

Official title:

Utility of Sodium Lactate Infusion During Septic Shock: Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03528213
• Other study ID #: 2015_56
• Secondary ID: 2017-002393-39
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 4, 2019
• Est. completion date: November 2023

Study information

• Verified date: August 2022
• Source: University Hospital, Lille
• Contact: Raphaël Favory, MD,PhD
• Phone: 03 20 44 54 94
• Email: raphael.favory[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Sodium Lactate light dose
bolus 2.5ml/kg then 0.25ml/kg/h
• Sodium Lactate high dose
bolus 2.5ml/kg then 0.5ml/kg/h
• Normal saline
normal saline at physician discretion

Locations

Country	Name	City	State
France	CH ARRAS	Arras
France	CH DOUAI	Douai
France	Ch Dunkerque	Dunkerque
France	CH LENS	Lens
France	Hôpital Roger Salengro, CHU	Lille
France	Hopital Victor Provo - Roubaix	Roubaix
France	Chu Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fluid balance	fluid balance	at 48 hours
Secondary	fluid balance at day 7		Day 7
Secondary	SOFA (Sequential Organ Failure Assessment)		Day 1, Day 2, Day 3, Day 7
Secondary	death in Intensive Care Unit (ICU)		Day 90
Secondary	number of patients dead		Day 28
Secondary	death in hospital		Day 90
Secondary	catecholamines free days		Day 28
Secondary	ventilator free days		Day 28
Secondary	renal replacement therapy free days		Day 28
Secondary	new kidney failure		Day 28
Secondary	nosocomial infections		day 90
Secondary	hypernatremia		Day 2
Secondary	hypokaliemia		Day 2
Secondary	metabolic alkalosis		day 2
Secondary	hemodynamic effects assessed by the PICCO® monitoring system		at 48 hours