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ASV and Targeted Fluid Resuscitation in Severe Burns

Adaptive Support Ventilation and Targeted Fluid Resuscitation in Patients With Severe Burn Injury: A Prospective Cohort Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07689097
Acronym
BURN-ASV/TFR
Enrollment
100
Registered
2026-07-08
Start date
2026-09-23
Completion date
2026-09-23
Last updated
2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn, Infusion Fluid, Mechanical Ventilation, War-Related Injuries

Keywords

burns, war - ralated injury, addaptive support ventilation, fluid therapy

Brief 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. 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.

Interventions

None listed

Sponsors

Ukrainian Society of Regional Anesthesia and Pain Therapy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Oxygenation Index During the First 7 DaysBaseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admissionOxygenation will be assessed using the PaO₂/FiO₂ ratio in adult patients with severe burn injury receiving Adaptive Support Ventilation and targeted fluid resuscitation.

Secondary

MeasureTime frameDescription
Static Lung ComplianceBaseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admissionStatic lung compliance will be assessed using ventilator-derived respiratory mechanics.
Driving PressureBaseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admissionDriving pressure will be calculated as plateau pressure minus positive end-expiratory pressure.
Cumulative Fluid BalanceThrough day 7 after ICU admissionCumulative fluid balance will be calculated as total fluid intake minus total fluid output.
Total Fluid Volume AdministeredFirst 24 hours, 48 hours, 72 hours, and through day 7 after ICU admissionTotal fluid volume administered will be recorded and expressed as mL/kg/% total body surface area burned.
Urine OutputFirst 24 hours, 48 hours, 72 hours, and through day 7 after ICU admissionUrine output will be recorded as mL/kg/hour.
Lactate ClearanceBaseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admissionLactate clearance will be calculated from serial serum lactate measurements.
Vasopressor RequirementThrough day 7 after ICU admissionNeed for vasopressor support and duration of vasopressor therapy will be recorded.
Mechanical Ventilation Duration During Early ICU PeriodThrough day 7 after ICU admissionDuration of invasive mechanical ventilation during the early observation period will be recorded.

Countries

Ukraine

Contacts

CONTACTDmytro Dmytriiev, PhD.Professor
dmytrodmytriiev@gmail.com+380674309449

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026