Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate-to-severe ARDS—a randomized, placebo-controlled, double-blind trial

Table 1 The Berlin definition of acute respiratory distress syndrome

Timing	Within 1 week of a known clinical insult or new or worsening respiratory symptoms
Chest imaging	Bilateral opacities—not fully explained by effusions, lobar/lung collapse or nodules ^a
Origin of edema	Respiratory failure not fully explained by cardiac failure or fluid overload Need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present
Oxygenation
Mild	200 mmHg < P_aO2/F_iO2 ≤ 300 mmHg with PEEP or CPAP ≥ 5 cm H₂O ^{b, c}
Moderate	100 mmHg < P_aO2/F_iO2 ≤ 200 mmHg with PEEP ≥ 5 cm H₂O
Severe	P_aO2/F_iO2 ≤ 100 mmHg with PEEP ≥ 5 cm H₂O

Abbreviations: CPAP, continuous positive airway pressure; F_iO2, fraction of inspired oxygen; P_aO2, partial pressure of arterial oxygen; PEEP, positive end-expiratory pressure
^a Chest radiograph or computed tomography scan
^b If altitude is higher than 1000 m, the correction factor should be calculated as follows: [P_aO2/F_iO2 × (barometric pressure/760)]
^c This may be delivered noninvasively in the mild acute respiratory distress syndrome group

ISSN: 1745-6215