ULIS1: Utility of Sodium Lactate Infusion During Septic Shock

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT03528213

Collaborator

(none)

Enrollment

Locations

Arms

48.9

Anticipated Duration (Months)

12.9

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Septic Shock	Drug: Sodium Lactate light dose Drug: Sodium Lactate high dose Drug: Normal saline	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

bolus then continuous infusion of molar sodium lactate (2 doses) or normal salinebolus then continuous infusion of molar sodium lactate (2 doses) or normal saline

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Utility of Sodium Lactate Infusion During Septic Shock: Pilot Study

Actual Study Start Date :

Oct 4, 2019

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Normal saline at physician discretion	Drug: Normal saline normal saline at physician discretion
Experimental: Sodium lactate light dose bolus 2.5ml/kg lactate 60min then 0.25ml/kg/h during 24hrs	Drug: Sodium Lactate light dose bolus 2.5ml/kg then 0.25ml/kg/h
Experimental: Sodium lactate high dose bolus 2.5ml/kg lactate 60min then 0.50ml/kg/h during 24hrs	Drug: Sodium Lactate high dose bolus 2.5ml/kg then 0.5ml/kg/h

Arm

Intervention/Treatment

Sham Comparator: Normal saline

at physician discretion

Drug: Normal saline

normal saline at physician discretion

Experimental: Sodium lactate light dose

bolus 2.5ml/kg lactate 60min then 0.25ml/kg/h during 24hrs

Drug: Sodium Lactate light dose

bolus 2.5ml/kg then 0.25ml/kg/h

Experimental: Sodium lactate high dose

bolus 2.5ml/kg lactate 60min then 0.50ml/kg/h during 24hrs

Drug: Sodium Lactate high dose

bolus 2.5ml/kg then 0.5ml/kg/h

Outcome Measures

Primary Outcome Measures

fluid balance [at 48 hours]
fluid balance

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	CH ARRAS	Arras	France
2	CH DOUAI	Douai	France
3	Ch Dunkerque	Dunkerque	France
4	CH LENS	Lens	France
5	Hôpital Roger Salengro, CHU	Lille	France
6	Hopital Victor Provo - Roubaix	Roubaix	France
7	Chu Rouen	Rouen	France