The Effect pf Goal-directed De-escalation in ARDS on Organ Function and Mortality (NCT04508296) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.