Utility of Sodium Lactate Infusion During Septic Shock

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

Detailed Description
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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

Official Title
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Utility of Sodium Lactate Infusion During Septic Shock: Pilot Study

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: Sodium Lactate light dose
* Drug: Sodium Lactate high dose
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: bolus then continuous infusion of molar sodium lactate (2 doses) or normal saline
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluid balance | fluid balance | at 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, fluid balance, metabolism, ischemia-reperfusion, treatment