Utility of Sodium Lactate Infusion During Septic Shock

Phase 2

• Conditions: Septic Shock
• Interventions: Drug: Normal saline; Drug: Sodium Lactate light dose; Drug: Sodium Lactate high dose

• Registration Number: NCT03528213
• Lead Sponsor: University Hospital, Lille

Brief 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

Study Timeline

• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-16
• Study First Posted: 2018-05-17
• Study Start: 2019-10-04
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-17
• Primary Completion: 2023-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal saline	at physician discretion
Sodium lactate light dose	Sodium Lactate light dose	bolus 2.5ml/kg lactate 60min then 0.25ml/kg/h during 24hrs
Sodium lactate high dose	Sodium Lactate high dose	bolus 2.5ml/kg lactate 60min then 0.50ml/kg/h during 24hrs

Primary Outcome Measures

Name	Time	Method
fluid balance	at 48 hours	fluid balance

Secondary Outcome Measures

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

Trial Locations

Locations (7)

CH ARRAS; 🇫🇷 Arras, France

CH DOUAI; 🇫🇷 Douai, France

Ch Dunkerque; 🇫🇷 Dunkerque, France

Hopital Victor Provo - Roubaix; 🇫🇷 Roubaix, France

Hôpital Roger Salengro, CHU; 🇫🇷 Lille, France

CH LENS; 🇫🇷 Lens, France

Chu Rouen; 🇫🇷 Rouen, France