Safety and efficacy of inhaled PEG-ADM in ARDS patients: a randomised controlled trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064173%3A_____%2F25%3A43928982" target="_blank" >RIV/00064173:_____/25:43928982 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11120/25:43928982
Result on the web
<a href="https://doi.org/10.1186/s13054-025-05617-y" target="_blank" >https://doi.org/10.1186/s13054-025-05617-y</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1186/s13054-025-05617-y" target="_blank" >10.1186/s13054-025-05617-y</a>
Alternative languages
Result language
angličtina
Original language name
Safety and efficacy of inhaled PEG-ADM in ARDS patients: a randomised controlled trial
Original language description
BACKGROUND: This study aimed to evaluate the safety and efficacy of inhaled pegylated adrenomedullin (PEG-ADM) for the management of acute respiratory distress syndrome in critically ill patients on mechanical ventilation. METHODS: A Phase 2a/b randomised, double-blind, placebo-controlled multicentre trial was conducted. Patients with acute respiratory distress syndrome were assigned to receive PEG-ADM 960 μg or 1920 μg, or placebo. The primary endpoints were safety, efficacy, and ventilator-free survival at Day 28. Efficacy was assessed using ventilator-free survival and the clinical utility index, a composite endpoint that includes extravascular lung water index, oxygenation index, non-pulmonary Sequential Organ Failure Assessment score. RESULTS: Ninety patients were randomised (PEG-ADM 960 μg: n = 29; PEG-ADM 1920 μg: n = 30; placebo: n = 31). Both dosages of PEG-ADM were well tolerated, with adverse event profiles similar to placebo. However, no significant efficacy was observed on the clinical utility index. Ventilator-free survival at Day 28 was lower in the PEG-ADM 960 μg group (52%) compared with the PEG-ADM 1920 μg (67%) and placebo (65%) groups. No significant differences were noted in overall mortality or the need for continued ventilation at Days 28 and 60. CONCLUSION: Inhaled PEG-ADM was well tolerated in patients with acute respiratory distress syndrome, but it did not improve clinical outcomes, which led to the early discontinuation after the first part of the trial for futility. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04417036 (date of registration: 4 June 2020).
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30221 - Critical care medicine and Emergency medicine
Result continuities
Project
—
Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Critical Care
ISSN
1364-8535
e-ISSN
1466-609X
Volume of the periodical
29
Issue of the periodical within the volume
October
Country of publishing house
GB - UNITED KINGDOM
Number of pages
9
Pages from-to
448
UT code for WoS article
001598844100001
EID of the result in the Scopus database
2-s2.0-105019822396