OPTImized Restrictive Strategy Targeting Non-Resuscitative FLUIDs in Septic Shock: Pilot Study.

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Jun 24, 2021

Keywords

ClinConnect Summary

Sepsis and its most severe form, septic shock, are the cause of nearly 30% of admission in intensive care unit (ICU). The related mortality rate varies from 20 to 60% according to the studied population and the type of the study. With the concomitant and rapid treatment of the source of infection, hemodynamic optimization with fluid infusion (fluid resuscitation) is the cornerstone of management of patients in septic shock. Nevertheless, fluid overload has been shown to be associated with poor outcome. The negative effects of a positive fluid balance on ICU outcomes for septic patients has ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient suffering from an infection already documented or suspected
• • Patient with organ dysfunction defined as an acute change in SOFA score ≥ 2 points
• • Patient with refractory hypotension requiring vasopressors to maintain a mean arterial pressure ≥ 65 mm Hg in spite of resuscitation with an adequate volume of intravenous fluids (according to the recommendations of the Surviving Sepsis campaign). The treatment by vasopressor must have been started less than 24 hours before inclusion and randomization.
• • Patient with hyperlactatemia (blood lactate \> 2 mmol / L). This criterion must be fulfilled at least once for the purpose of the diagnosis within the 24 hours preceding inclusion and randomization.
• • Patient or close relative / legal representative / family member / curator / tutor must have given written informed consent and signed the consent form for the patient included in an emergency situation
• • Patient must be covered by a health insurance scheme.
• • Adult patient (≥18 years) under 85 years old (\< 85).
• Exclusion Criteria:
• • Patient who has had a previous episode of septic shock requiring vasopressor administration or mechanical ventilation or renal replacement therapy during the current ICU stay.
• • A patient whose life expectancy is shortened due to his/her initial health condition or a moribund patient whose life expectancy is less than 48 hours or whose decision to limit comprehensive care was made before including the patient.
• • Patient who has had a recent cardiac arrest (during current hospital stay)
• • Patient requiring emergency renal-replacement therapy (hyperkalemia \[potassium \> 6.5 mmol/l\] refractory to medical treatment and/or metabolic acidosis \[pH \<7.15 and partial pressure of carbon dioxide (pCO2) \<45 mmHg\] refractory to medical treatment and/or pulmonary edema in anuric patients who do not respond to diuretic therapy).
• • Patient with KDIGO 3 acute kidney injury and likely to require renal-replacement therapy within the next 24 hours, as determined by the patient's clinician in charge
• • Patients with end-stage chronic renal failure or patients already undergoing chronic dialysis
• • Severely malnourished patient in whom nutritional support is an emergency procedure (body mass index \<18 kg / m2)
• • Patient participating in or having participated in an interventional study with similar patient outcome in the previous 3 months.
• • Patient in an exclusion period determined by another study.
• • Patient under legal protection.
• • Pregnant patient (positive serum pregnancy test).