ULIS-1 is an open-label pilot study concerning utility of molar sodium lactate in fluid balance in septic shock patients
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
bolus 2.5ml/kg then 0.25ml/kg/h
bolus 2.5ml/kg then 0.5ml/kg/h
normal saline at physician discretion
CH ARRAS
Arras, France
CH DOUAI
Douai, France
Ch Dunkerque
Dunkirk, France
CH LENS
Lens, France
Hôpital Roger Salengro, CHU
fluid balance
fluid balance
Time frame: at 48 hours
fluid balance at day 7
Time frame: Day 7
SOFA (Sequential Organ Failure Assessment)
Time frame: Day 1, Day 2, Day 3, Day 7
death in Intensive Care Unit (ICU)
Time frame: Day 90
number of patients dead
Time frame: Day 28
death in hospital
Time frame: Day 90
catecholamines free days
Time frame: Day 28
ventilator free days
Time frame: Day 28
renal replacement therapy free days
Time frame: Day 28
new kidney failure
Time frame: Day 28
nosocomial infections
Time frame: day 90
hypernatremia
Time frame: Day 2
hypokaliemia
Time frame: Day 2
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Lille, France
Hopital Victor Provo - Roubaix
Roubaix, France
Chu Rouen
Rouen, France
metabolic alkalosis
Time frame: day 2
hemodynamic effects assessed by the PICCO® monitoring system
Time frame: at 48 hours