BurnBURN-ASV/TFRNCT07689097
ASV and Targeted Fluid Resuscitation in Severe Burns
An observational study of Burn and War-Related Injuries, run by Ukrainian Society of Regional Anesthesia and Pain Therapy at 1 site in Ukraine.
Trial summary
This prospective cohort study will evaluate the use of Adaptive Support Ventilation (ASV) together with targeted fluid resuscitation in adult patients with severe burn injuries requiring mechanical ventilation in the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Burn, War-Related Injuries, Mechanical Ventilation
- How many people
- 100 participants
- Where
- 1 siteUkraine
- Study dates
- 23 Sep 2026to 23 Sep 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population will consist of adult patients admitted to the intensive care unit with severe burn injury requiring invasive mechanical ventilation during the acute phase of treatment. Patients will receive Adaptive Support Ventilation (ASV) and targeted fluid resuscitation as part of routine clinical care. The study will include patients with thermal, flame, scald, electrical, chemical, and combat-related burn injuries, including burns associated with drone and thermobaric attacks, when applicable. Clinical, respiratory, hemodynamic, and laboratory data will be collected prospectively during the first seven days of intensive care to evaluate respiratory function, fluid resuscitation, and early clinical outcomes.
Who may be able to join
- Adults aged 18 years or older.
- Hospital admission with severe burn injury involving ≥20% total body surface area (TBSA).
- Requirement for invasive mechanical ventilation within 24 hours after admission to the intensive care unit.
- Expected need for mechanical ventilation for at least 48 hours.
- Treatment with Adaptive Support Ventilation (ASV) and targeted fluid resuscitation according to institutional protocols.
- Written informed consent provided by the patient or legally authorized representative, in accordance with local regulations.
Who cannot join
- Age younger than 18 years.
- Burn injury involving <20% TBSA.
- Mechanical ventilation initiated more than 24 hours after ICU admission.
- Pregnancy.
- Pre-existing chronic dependence on invasive mechanical ventilation.
- Severe traumatic brain injury requiring a specific ventilation strategy.
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- Terminal illness with an expected survival of less than 24 hours.
- Enrollment in another interventional clinical trial that may influence study outcomes.
- Inability to obtain essential clinical data required for study analysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine1 site
Vinnitsya Regional Clinical Hospital n.a Pirogov
Vinnytsia, 21000
Dmytro Dmytriiev, Phd, 0674309449, dmytrodmytriiev@gmail.com
About this study
Official title: Adaptive Support Ventilation and Targeted Fluid Resuscitation in Patients With Severe Burn Injury: A Prospective Cohort Study
This prospective cohort study will evaluate the use of Adaptive Support Ventilation (ASV) together with targeted fluid resuscitation in adult patients with severe burn injuries requiring mechanical ventilation in the intensive care unit.
Patients with extensive burns often develop respiratory failure and require both invasive mechanical ventilation and large-volume fluid resuscitation during the first days after injury. The study will assess whether the combination of ASV and targeted fluid resuscitation is associated with improved oxygenation, respiratory mechanics, fluid balance, and early clinical outcomes during the first 72 hours of intensive care.
Clinical data, ventilatory parameters, laboratory results, hemodynamic variables, and fluid resuscitation characteristics will be collected as part of routine clinical care. The findings may help optimize early intensive care management for patients with severe burn injuries and improve future treatment strategies.
Read the detailed description
Severe burn injury is frequently associated with profound systemic inflammation, capillary leak syndrome, hypovolemic shock, inhalation injury, and acute respiratory failure requiring invasive mechanical ventilation. The first 72 hours following injury represent a critical phase during which both ventilatory support and fluid resuscitation substantially influence organ function and subsequent clinical outcomes.
Adaptive Support Ventilation (ASV) is a closed-loop mechanical ventilation mode that automatically adjusts ventilatory parameters according to the patient's respiratory mechanics while maintaining predefined ventilation targets. This approach has the potential to optimize lung-protective ventilation, reduce unnecessary ventilatory stress, and improve patient-ventilator synchrony. At the same time, targeted fluid resuscitation aims to individualize fluid administration based on physiological and clinical parameters in order to maintain adequate tissue perfusion while minimizing fluid overload and the development of burn-related edema.
This prospective cohort study will evaluate the association between the combined use of Adaptive Support Ventilation and targeted fluid resuscitation during the early management of adult patients with severe burn injuries admitted to the intensive care unit. Patients will be managed according to institutional protocols, and no study-specific interventions will be introduced beyond routine clinical practice.
Clinical, respiratory, hemodynamic, and laboratory data will be collected prospectively during the first 72 hours after intensive care unit admission. Ventilatory variables, oxygenation indices, respiratory mechanics, fluid administration, cumulative fluid balance, urine output, and organ dysfunction parameters will be recorded using standard monitoring systems and electronic medical records.
The study aims to characterize the physiological effects of early Adaptive Support Ventilation combined with targeted fluid resuscitation and to evaluate their association with respiratory function, fluid balance, and early clinical outcomes in patients with severe burn injury. The findings are expected to provide real-world evidence to support optimization of intensive care strategies for critically ill burn patients.
- Conditions
- Burn, War-Related Injuries, Mechanical Ventilation, Infusion Fluid
- Keywords
- burns, war - ralated injury, addaptive support ventilation, fluid therapy
- Medical subject headings
- Burns, War-Related Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Support Ventilation With Targeted Fluid Resuscitation | Adult patients with severe burn injury requiring invasive mechanical ventilation who are managed using Adaptive Support Ventilation (ASV) together with targeted fluid resuscitation during the early phase of intensive care. All treatments are delivered as part of routine clinical practice, and clinical, respiratory, hemodynamic, and laboratory data are collected prospectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxygenation Index During the First 7 Days
Oxygenation will be assessed using the PaO₂/FiO₂ ratio in adult patients with severe burn injury receiving Adaptive Support Ventilation and targeted fluid resuscitation.
Measured: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Secondary outcomes (8)
Static Lung Compliance
Static lung compliance will be assessed using ventilator-derived respiratory mechanics.
Measured: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Driving Pressure
Driving pressure will be calculated as plateau pressure minus positive end-expiratory pressure.
Measured: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Cumulative Fluid Balance
Cumulative fluid balance will be calculated as total fluid intake minus total fluid output.
Measured: Through day 7 after ICU admission
Total Fluid Volume Administered
Total fluid volume administered will be recorded and expressed as mL/kg/% total body surface area burned.
Measured: First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission
Urine Output
Urine output will be recorded as mL/kg/hour.
Measured: First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission
Lactate Clearance
Lactate clearance will be calculated from serial serum lactate measurements.
Measured: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Vasopressor Requirement
Need for vasopressor support and duration of vasopressor therapy will be recorded.
Measured: Through day 7 after ICU admission
Mechanical Ventilation Duration During Early ICU Period
Duration of invasive mechanical ventilation during the early observation period will be recorded.
Measured: Through day 7 after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start23 Sep 2026 (estimated)
- Primary completion23 Sep 2026 (estimated)
- Study completion23 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain Therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689097
- Sponsor's protocol ID
- 11v213022026
- Acronym
- BURN-ASV/TFR
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this study will be made available to qualified researchers upon reasonable request. Data will be shared after publication of the primary study results and following approval of a methodologically sound research proposal. Shared data will include demographic characteristics, burn severity, respiratory parameters, fluid resuscitation variables, laboratory measurements, and outcome data. Data sharing will require a signed data access agreement to ensure participant confidentiality and compliance with institutional and ethical requirements.
Publications
Kakizaki R, Fukuda S, Liu K, Nakamoto K, Batsaikhan TA, Khan MN, Branson RD, Enkhbaatar P, Kinsky MP. CLOSED-LOOP VENTILATION AND OXYGENATION WITH DECISION SUPPORT FLUID RESUSCITATION TO TREAT MAJOR BURN INJURY WITH SMOKE-INDUCED ACUTE RESPIRATORY DISTRESS SYNDROME. Shock. 2025 May 1;63(5):781-787. doi: 10.1097/SHK.0000000000002552. Epub 2025 Jan 22.
PubMed 39840968
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Support Ventilation and Targeted Fluid Resuscitation in Patients With Severe Burn Injury: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07689097
- Acronym / sponsor ID
- BURN-ASV/TFR / 11v213022026
- Conditions
- Burn, War-Related Injuries, Mechanical Ventilation, Infusion Fluid
- Keywords
- burns, war - ralated injury, addaptive support ventilation, fluid therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain TherapyUniversity, hospital or other
- Study start
- 23 Sep 2026 (estimated)
- Primary completion
- 23 Sep 2026 (estimated)
- Study completion
- 23 Sep 2026 (estimated)
- First posted
- 8 Jul 2026 (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.
This prospective cohort study will evaluate the use of Adaptive Support Ventilation (ASV) together with targeted fluid resuscitation in adult patients with severe burn injuries requiring mechanical ventilation in the intensive care unit.
Patients with extensive burns often develop respiratory failure and require both invasive mechanical ventilation and large-volume fluid resuscitation during the first days after injury. The study will assess whether the combination of ASV and targeted fluid resuscitation is associated with improved oxygenation, respiratory mechanics, fluid balance, and early clinical outcomes during the first 72 hours of intensive care.
Clinical data, ventilatory parameters, laboratory results, hemodynamic variables, and fluid resuscitation characteristics will be collected as part of routine clinical care. The findings may help optimize early intensive care management for patients with severe burn injuries and improve future treatment strategies.
Detailed description
Severe burn injury is frequently associated with profound systemic inflammation, capillary leak syndrome, hypovolemic shock, inhalation injury, and acute respiratory failure requiring invasive mechanical ventilation. The first 72 hours following injury represent a critical phase during which both ventilatory support and fluid resuscitation substantially influence organ function and subsequent clinical outcomes.
Adaptive Support Ventilation (ASV) is a closed-loop mechanical ventilation mode that automatically adjusts ventilatory parameters according to the patient's respiratory mechanics while maintaining predefined ventilation targets. This approach has the potential to optimize lung-protective ventilation, reduce unnecessary ventilatory stress, and improve patient-ventilator synchrony. At the same time, targeted fluid resuscitation aims to individualize fluid administration based on physiological and clinical parameters in order to maintain adequate tissue perfusion while minimizing fluid overload and the development of burn-related edema.
This prospective cohort study will evaluate the association between the combined use of Adaptive Support Ventilation and targeted fluid resuscitation during the early management of adult patients with severe burn injuries admitted to the intensive care unit. Patients will be managed according to institutional protocols, and no study-specific interventions will be introduced beyond routine clinical practice.
Clinical, respiratory, hemodynamic, and laboratory data will be collected prospectively during the first 72 hours after intensive care unit admission. Ventilatory variables, oxygenation indices, respiratory mechanics, fluid administration, cumulative fluid balance, urine output, and organ dysfunction parameters will be recorded using standard monitoring systems and electronic medical records.
The study aims to characterize the physiological effects of early Adaptive Support Ventilation combined with targeted fluid resuscitation and to evaluate their association with respiratory function, fluid balance, and early clinical outcomes in patients with severe burn injury. The findings are expected to provide real-world evidence to support optimization of intensive care strategies for critically ill burn patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive Support Ventilation With Targeted Fluid Resuscitation | – | –Adult patients with severe burn injury requiring invasive mechanical ventilation who are managed using Adaptive Support Ventilation (ASV) together with targeted fluid resuscitation during the early phase of intensive care. All treatments are delivered as part of routine clinical practice, and clinical, respiratory, hemodynamic, and laboratory data are collected prospectively. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will consist of adult patients admitted to the intensive care unit with severe burn injury requiring invasive mechanical ventilation during the acute phase of treatment. Patients will receive Adaptive Support Ventilation (ASV) and targeted fluid resuscitation as part of routine clinical care. The study will include patients with thermal, flame, scald, electrical, chemical, and combat-related burn injuries, including burns associated with drone and thermobaric attacks, when applicable. Clinical, respiratory, hemodynamic, and laboratory data will be collected prospectively during the first seven days of intensive care to evaluate respiratory function, fluid resuscitation, and early clinical outcomes.
Key inclusion criteria (6 listed)
- Adults aged 18 years or older.
- Hospital admission with severe burn injury involving ≥20% total body surface area (TBSA).
- Requirement for invasive mechanical ventilation within 24 hours after admission to the intensive care unit.
- Expected need for mechanical ventilation for at least 48 hours.
- Treatment with Adaptive Support Ventilation (ASV) and targeted fluid resuscitation according to institutional protocols.
Key exclusion criteria (9 listed)
- Age younger than 18 years.
- Burn injury involving <20% TBSA.
- Mechanical ventilation initiated more than 24 hours after ICU admission.
- Pregnancy.
- Pre-existing chronic dependence on invasive mechanical ventilation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Oxygenation Index During the First 7 Days
Time frame: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Oxygenation will be assessed using the PaO₂/FiO₂ ratio in adult patients with severe burn injury receiving Adaptive Support Ventilation and targeted fluid resuscitation.
8 secondary outcomes
Static Lung Compliance
Time frame: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Driving Pressure
Time frame: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Cumulative Fluid Balance
Time frame: Through day 7 after ICU admission
Total Fluid Volume Administered
Time frame: First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission
Urine Output
Time frame: First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission
Lactate Clearance
Time frame: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Vasopressor Requirement
Time frame: Through day 7 after ICU admission
Mechanical Ventilation Duration During Early ICU Period
Time frame: Through day 7 after ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Results publication: PubMed 39840968Kakizaki R, Fukuda S, Liu K, Nakamoto K, Batsaikhan TA, Khan MN, Branson RD, Enkhbaatar P, Kinsky MP. CLOSED-LOOP VENTILATION AND OXYGENATION WITH DECISION SUPPORT FLUID RESUSCITATION TO TREAT MAJOR BURN INJURY WITH SMOKE-INDUCED ACUTE RESPIRATORY DISTRESS SYNDROME. Shock. 2025 May 1;63(5):781-787. doi: 10.1097/SHK.0000000000002552. Epub 2025 Jan 22.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in this study will be made available to qualified researchers upon reasonable request. Data will be shared after publication of the primary study results and following approval of a methodologically sound research proposal. Shared data will include demographic characteristics, burn severity, respiratory parameters, fluid resuscitation variables, laboratory measurements, and outcome data. Data sharing will require a signed data access agreement to ensure participant confidentiality and compliance with institutional and ethical requirements.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn and War-Related Injuries, run by Ukrainian Society of Regional Anesthesia and Pain Therapy at 1 site in Ukraine.
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 8 Jul 2026. 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 Ukraine. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dmytro Dmytriiev, PhD.Professor (+380674309449, dmytrodmytriiev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxygenation Index During the First 7 Days (time frame: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07689097, which also lists 1 linked publication.
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 8 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.