ASV and Targeted Fluid Resuscitation in Severe Burns

NCT07689097 | Not Yet Recruiting

• 1 other identifier: 11v213022026
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (8)

• Static Lung Compliance

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

• Driving Pressure

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

• Cumulative Fluid Balance

  Through day 7 after ICU admission

• Total Fluid Volume Administered

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

• Urine Output

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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ukrainian Society of Regional Anesthesia and Pain Therapy: lead

Study Sites (1)

Vinnitsya Regional Clinical Hospital n.a Pirogov

Vinnytsia, 21000, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 39840968 RESULT

MeSH Terms

Conditions

Burns; War-Related Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Dmytro Dmytriiev, PhD.Professor

CONTACT

+380674309449; dmytrodmytriiev@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, head of intensive care department

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 8, 2026
• Study Start (Estimated): September 23, 2026
• Primary Completion (Estimated): September 23, 2026
• Study Completion (Estimated): September 23, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Individual participant data (IPD) will be available beginning 6 months after publication of the primary study results and will remain available for 5 years following publication.
• Access Criteria: Access to de-identified individual participant data (IPD), the study protocol, and the statistical analysis plan will be provided to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the principal investigator. Approved researchers will be required to sign a data use agreement before access is granted. Data will be shared in a secure electronic format while maintaining participant confidentiality and compliance with institutional and ethical requirements.

Locations

UA (1)