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ASV and Targeted Fluid Resuscitation in Severe Burns (BURN-ASV/TFR)

4. Juli 2026 aktualisiert von: Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

100

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Ukraine
      • Vinnytsia, Ukraine, 21000
        • Vinnitsya Regional Clinical Hospital n.a Pirogov
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Oxygenation Index During the First 7 Days
Zeitfenster: 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.
Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Static Lung Compliance
Zeitfenster: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Static lung compliance will be assessed using ventilator-derived respiratory mechanics.
Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Driving Pressure
Zeitfenster: 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.
Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Cumulative Fluid Balance
Zeitfenster: Through day 7 after ICU admission
Cumulative fluid balance will be calculated as total fluid intake minus total fluid output.
Through day 7 after ICU admission
Total Fluid Volume Administered
Zeitfenster: 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.
First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission
Urine Output
Zeitfenster: First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission
Urine output will be recorded as mL/kg/hour.
First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission
Lactate Clearance
Zeitfenster: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Lactate clearance will be calculated from serial serum lactate measurements.
Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Vasopressor Requirement
Zeitfenster: Through day 7 after ICU admission
Need for vasopressor support and duration of vasopressor therapy will be recorded.
Through day 7 after ICU admission
Mechanical Ventilation Duration During Early ICU Period
Zeitfenster: Through day 7 after ICU admission
Duration of invasive mechanical ventilation during the early observation period will be recorded.
Through day 7 after ICU admission

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

23. September 2026

Primärer Abschluss (Geschätzt)

23. September 2026

Studienabschluss (Geschätzt)

23. September 2026

Studienanmeldedaten

Zuerst eingereicht

29. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Juli 2026

Zuerst gepostet (Tatsächlich)

8. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Juli 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 11v213022026

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

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.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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