Inhibition of Plasma Kallikrein as a New Therapy for Lung Injury

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1 study investigating safety of lanadelumab administration to patients with lung injury

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St Vincent's Institute of Medical Research

Criteria

Inclusion Criteria:

• Age >18 years admitted to the ICU with primary diagnosis of lung injury. The criteria for the diagnosis of lung injury include five principal elements: hypoxemia (blood oxygen saturation (PaO2) ≤92% when breathing ambient air, ratio of PaO2 to the fraction of inspired oxygen (FiO2) ≤300), diffuse pulmonary infiltrates on chest radiographs, decreased lung compliance, and the absence of congestive heart failure.

• Both males and females will be recruited in the proportion in which they are admitted to the ICU with lung injury.

• Arterial cannula in place as part of usual care for the measurement of blood gases.

• Patients may or may not be intubated and mechanically ventilated.

• Able to provide informed consent, or if unable to do so, a responsible person:

medical treatment decision maker is available (by telephone if necessary) who can be approached to seek consent.

Exclusion Criteria:

• Other causes of lung infiltrates: pulmonary oedema, alveolar haemorrhage, adverse drug reactions, radiation injury and the idiopathic pneumonitis syndrome.

• Significant dysfunction of non-pulmonary organs in the opinion of the treating ICU consultant.

• Death is deemed imminent or inevitable or there is underlying disease with a life expectancy of less than 90 days.

• Previously enrolled in this study.

• Enrolled in another study.

• Usually receives home oxygen.

• Usually receives any type of assisted ventilation at home. e.g. continuous positive airway pressure for obstructive sleep apnoea.

• Pregnant or might be pregnant. Women aged 18 to 49 are excluded unless there is documented menopause, hysterectomy or surgical sterilisation, or a pregnancy test is negative.

• Objection from the treating clinician.

• Consent refused by the patient or substitute decision maker.