Overview

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.