CompletedNot Applicable

The Effect pf Goal-directed De-escalation in ARDS on Organ Function and Mortality

Russia46 participantsStarted 2016-03-10

Plain-language summary

Objective: To compare two de-escalation strategies guided by either extravascular lung water or global end-diastolic volume-oriented algorithms in patients with sepsis and ARDS. Design: A prospective randomized study. Setting: City Hospital #1 of Arkhangelsk, Russia, mixed ICU. Patients: Sixty patients with sepsis and ARDS were randomized to receive de-escalation fluid therapy, guided either by extravascular lung water index (EVLWI, n = 30) or global end-diastolic volume index (GEDVI, n = 30). Intervention: In case of GEDVI \> 650 mL/m2 or EVLWI \> 10 mL/kg, diuretics and/or controlled ultrafiltration were administered. The primary goal of de-escalation was to achieve the cumulative 48-hr fluid balance in the range of 0 to - 3000 mL. If GEDVI \< 650 mL/m2 or EVLWI \< 10 mL/kg, the target fluid balance was set from 0 to +3000 mL.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * The presence of sepsis ( the third international definition of sepsis and septic shock ) * The precence of ARDS (the Berlin definition of ARDS) * mechanical ventilation before the study for at least 24 hrs * the age of the patient \> 18 years. Exclusion Criteria: * continuous infusion of norepinephrine in a dose exceeding 0.4 mcg/kg/min to maintain mean arterial pressure (MAP) within 65-75 mm Hg, * morbid obesity with BMI \> 40 kg/m2, * severe brain injury, * chronic kidney diseases, * pregnancy, * known irreversible underlying conditions such as end-stage neoplasms.

What they're measuring

Improvement of organ function

Timeframe: 48 hours

Trial details

NCT IDNCT04508296

SponsorNorthern State Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-10