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NCT Number: NCT07689097

ASV and Targeted Fluid Resuscitation in Severe Burns

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vinnitsya Regional Clinical Hospital n.a Pirogov

Vinnytsia, 21000, Ukraine

Location contact

Dmytro Dmytriiev, Phd

CONTACT

[email protected]

0674309449

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Static Lung Compliance

    Time frame: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission

    Static lung compliance will be assessed using ventilator-derived respiratory mechanics.

  2. Driving Pressure

    Time frame: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission

    Driving pressure will be calculated as plateau pressure minus positive end-expiratory pressure.

  3. Cumulative Fluid Balance

    Time frame: Through day 7 after ICU admission

    Cumulative fluid balance will be calculated as total fluid intake minus total fluid output.

  4. Total Fluid Volume Administered

    Time frame: First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission

    Total fluid volume administered will be recorded and expressed as mL/kg/% total body surface area burned.

  5. Urine Output

    Time frame: First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission

    Urine output will be recorded as mL/kg/hour.

  6. Lactate Clearance

    Time frame: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission

    Lactate clearance will be calculated from serial serum lactate measurements.

  7. Vasopressor Requirement

    Time frame: Through day 7 after ICU admission

    Need for vasopressor support and duration of vasopressor therapy will be recorded.

  8. Mechanical Ventilation Duration During Early ICU Period

    Time frame: Through day 7 after ICU admission

    Duration of invasive mechanical ventilation during the early observation period will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Dmytro Dmytriiev, PhD.Professor

CONTACT

[email protected]

+380674309449

Sponsors and collaborators

Lead sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Other

Registry information

Official study title

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

Acronym: BURN-ASV/TFR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

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.

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