Septic Shock
Conditions
Keywords
sepsis, fluid balance, metabolism, ischemia-reperfusion, treatment
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
Interventions
DRUGSodium Lactate light dose
bolus 2.5ml/kg then 0.25ml/kg/h
DRUGSodium Lactate high dose
bolus 2.5ml/kg then 0.5ml/kg/h
DRUGNormal saline
normal saline at physician discretion
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
bolus then continuous infusion of molar sodium lactate (2 doses) or normal saline
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fluid balance | at 48 hours | fluid balance |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| fluid balance at day 7 | Day 7 |
| 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 |
| renal replacement therapy free days | Day 28 |
Countries
France
Outcome results
None listed