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

NCT04508296 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-03-22

No results posted yet for this study

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.

Conditions

  • ARDS, Human
  • Sepsis, Severe

Interventions

DIAGNOSTIC_TEST

Goal directed de-escalation therapy

Patients received de-escalation fluid management using either diuretics or ultrafiltration during continuous RRT in the case of GEDVI \> 650 mL/m2 or EVLWI \> 10 mL/kg depending on the randomization group. The primary goal of de-escalation was to obtain a cumulative fluid balance after 48 hrs from the study baseline of 0 to -3000 mL. In the case of GEDVI \< 650 mL/m2 or EVLWI \< 10 mL/kg, the target fluid balance was in the range of 0 to +3000 mL

Sponsors & Collaborators

  • Northern State Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-10
Primary Completion
2020-12-10
Completion
2020-12-10

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04508296 on ClinicalTrials.gov