Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma

Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · Dec 8, 2017

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called dornase alfa, which is delivered through inhalation, on patients who have suffered severe trauma and are experiencing respiratory distress. The goal is to see if this treatment can help reduce the risk of serious lung problems, specifically a condition known as acute respiratory distress syndrome (ARDS). Researchers hope to lower the occurrence of moderate to severe ARDS from 45% to 30% in the first week of intensive care. They will compare the effects of dornase alfa with a placebo (a saline solution) to see how well it works.

To participate in this trial, patients must be adults over 18 years old with significant injuries (a score indicating severity greater than 15) and currently on mechanical ventilation for more than 48 hours in the intensive care unit (ICU). They will need consent from a family member to take part. Patients in the study can expect to receive either the dornase alfa treatment or the placebo during their stay in the ICU, and researchers will monitor their recovery, lung function, and overall health. This trial is important as it could lead to better treatment options for patients with severe trauma and related breathing difficulties.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult (\>18) patient of either sex affiliated to the National Health Service
• • Severe trauma patient (either blunt or penetrating), Injury Severity Score \> 15
• • Under mechanical ventilation for an expected duration \> 48h
• • Admitted in the ICU
• • Signed informed consent from the patient's relative
• • Patient equipped with an indwelling arterial catheter
• Exclusion Criteria:
• • Pregnancy or breast feeding
• • Opposition from the patient or his/her relatives
• • Protected major (Guardianship)
• • Contraindication to the use of dornase alfa
• • Known intolerance to dornase alfa