ARDS, HumanNCT04508296
The Effect pf Goal-directed De-escalation in ARDS on Organ Function and Mortality
A study testing Goal directed de-escalation therapy in people with ARDS, Human and Sepsis, Severe, run by Northern State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human, Sepsis, Severe
- What is being tested?
- Goal directed de-escalation therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteRussia
- Study dates
- 10 Mar 2016to 10 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: De-escalation Fluid Management Guided by Volumetric Parameters in Patients With Sepsis and ARDS
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.
Read the detailed description
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
- Conditions
- ARDS, Human, Sepsis, Severe
- Being tested
- Goal directed de-escalation therapy
- Keywords
- de-escalation therapy, acute respiratory distress syndrome, extravascular lung water, global end-diastolic volume, sepsis
- Medical subject headings
- Respiratory Distress Syndrome, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal directed de-escalation therapyDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: Goal directed de-escalation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
Secondary outcomes (1)
Survival
The secondary endpoint was to evaluate whether ELWI- or GEDVI-oriented goal-directed therapy can lead to the decrement of the 28-days mortality
Measured: 28-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start10 Mar 2016
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikhail Y. Kirov, Northern State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508296
- Sponsor's protocol ID
- De-escalation ARDS_2016
- Status last verified
- Mar 2024
- First submitted
- 5 Aug 2020
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-escalation Fluid Management Guided by Volumetric Parameters in Patients With Sepsis and ARDS
- ClinicalTrials.gov ID
- NCT04508296
- Acronym / sponsor ID
- De-escalation ARDS_2016
- Conditions
- ARDS, Human, Sepsis, Severe
- Keywords
- de-escalation therapy, acute respiratory distress syndrome, extravascular lung water, global end-diastolic volume, sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Northern State Medical UniversityUniversity, hospital or other
- Study start
- 10 Mar 2016 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GEDVI-oriented de-escalation | Experimental | Diagnostic Test: Goal directed de-escalation therapyPatients 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 |
| EVLWI-oriented de-escalation | Experimental | Diagnostic Test: Goal directed de-escalation therapyPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal directed de-escalation therapyPatients 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 | Diagnostic test | EVLWI-oriented de-escalation, GEDVI-oriented de-escalation |
Primary outcome
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.
1 secondary outcome
Survival
Time frame: 28-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal directed de-escalation therapy in people with ARDS, Human and Sepsis, Severe, run by Northern State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of organ function (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.