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

NCT04508296 | Completed

• 1 other identifier: De-escalation ARDS_2016
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

de-escalation therapy; acute respiratory distress syndrome; extravascular lung water; global end-diastolic volume; sepsis

Outcome Measures

Primary Outcomes (1)

• Improvement of organ function

  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.

  48 hours

Secondary Outcomes (1)

• Survival

  28-day

Study Arms (2)

GEDVI-oriented de-escalation

EXPERIMENTAL

Patients received de-escalation fluid management using either diuretics or ultrafiltration during continuous RRT. In the case of GEDVI \> 650 mL/m2 the primary goal of de-escalation is 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 he target fluid balance is in the range of 0 to +3000 mL

Diagnostic Test: Goal directed de-escalation therapy

EVLWI-oriented de-escalation

EXPERIMENTAL

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

Diagnostic Test: Goal directed de-escalation therapy

Interventions

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

EVLWI-oriented de-escalation; GEDVI-oriented de-escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern State Medical University: lead

Study Sites (1)

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

Arkhangelsk, 163000, Russia

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Sepsis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 11, 2020
• Study Start: March 10, 2016
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

RU (1)