Skip to main content
OpenTrials
Completed

NCT Number: NCT04508296

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City Hospital # 1 n.a. E.E. Volosevich

Arkhangelsk, 163000, Russia

About this study

In all patients, investigators catheterized the internal jugular or the subclavian vein with a triple-lumen central venous catheter (Certofix, B|Braun, Germany) and the femoral artery with a thermistor-tipped arterial catheter (5F, PV2015L20, Pulsion Medical Systems, Munich, Germany). The arterial blood pressure was recorded from a side port of the catheter. Hemodynamic monitoring was carried out using the method of transpulmonary thermodilution (PiCCO2 monitor, Pulsion Medical Systems, Germany) by a triplicate 15 mL bolus of cold (< 8 °C) 0.9% saline solution.

Mechanical ventilation (Puritan Bennett 840 and 980, Medtronic, USA) was performed according to the ARDS Network protocol, using pressure-controlled ventilation with tidal volume 6-7 ml/kg of predicted body weight, with a Ppeak not exceeding 35 cm H2O, positive end-expiratory pressure (PEEP) and a fraction of inspiratory oxygen (FiO2) levels adjusted to maintain SpO2 within a 92-97% range.

The target fluid balance was achieved by continuous infusion of furosemide with an initial dose of 0.07 mcg/kg/hr and a minimal duration of 12 hrs. In case of failure to reach a negative fluid balance by means of diuretics, started controlled ultrafiltration using continuous veno-venous hemofiltration (CVVH, multiFiltrate, Fresenius Medical Care, Germany). For fluid replacement, if necessary, investigators administered balanced crystalloid solutions (Sterofundin Iso/G5, B|Braun, Germany) with an initial infusion rate of 6-7 ml/kg/hr.

Heart rate (HR), MAP, cardiac index (CI), GEDVI, EVLWI, pulmonary vascular permeability index (PVPI), central venous pressure (CVP), systemic vascular resistance index (SVRI), pulse pressure variation (PPV), and stroke volume variation (SVV) were assessed using transpulmonary thermodilution and arterial pulse contour analysis. During the study, investigators also assessed blood gases (ABL Flex 800 Radiometer, Denmark) and biochemical parameters (Random Access A-25, BioSystems, Spain). All measurements were performed at baseline, at 24 and at 48 hrs of the goal-directed de-escalation

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Goal directed de-escalation therapy

Diagnostic Test

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

Primary outcomes

  1. Improvement of organ function

    Time frame: 48 hours

    To assess if ELWI- or GEDVI-oriented goal-directed therapy can lead to the decrement of the SOFA scale by more than 20% in comparison with baseline values.

Secondary outcomes

  1. Survival

    Time frame: 28-day

    The secondary endpoint was to evaluate whether ELWI- or GEDVI-oriented goal-directed therapy can lead to the decrement of the 28-days mortality

Sponsors and collaborators

Lead sponsor

Northern State Medical University

Other

Registry information

Official study title

De-escalation Fluid Management Guided by Volumetric Parameters in Patients With Sepsis and ARDS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 11, 2020
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.