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A double-blind, placebo-controlled, randomised, multicentre, proof-of-concept and dose-finding phase II clinical trial to investigate the safety, tolerability and efficacy of adrecizumab in patients with septic shock and elevated adrenomedullin concentration (AdrenOSS-2)
Plain-language guide to PMID 30782906 (2019): randomized and double-blind clinical study of Adrenomedullin in 300 patients.
Key Facts
- PMID
- 30782906
- Journal
- BMJ open
- Year
- 2019
- Study type
- Clinical Study
- Authors
- Geven C et al. (10 authors)
- DOI
- 10.1136/bmjopen-2018-024475
What This Study Did, in Plain Language
What Was Tested
Researchers studied Adrenomedullin in this clinical study publication.
Apart from treatment with antibiotics and organ support, no approved specific adjunct therapies currently exist.
Adrenomedullin (ADM) is a vasoactive peptide.
Who Took Part
According to the abstract, 300 patients were involved.
A total of 300 patients will be enrolled at approximately 30 sites within the European Union.
Patient selection is guided by clinical parameters, and biomarker-guided by measurement of circulating biologically active ADM concentration at admission.
How the Study Was Run
The design is described as randomized, double-blind, placebo-controlled and multicenter.
Random assignment meant chance, not the researchers, decided who got Adrenomedullin and who got the comparison, which limits bias.
Blinding on both sides kept the patients and researchers unaware of who received Adrenomedullin.
A placebo (an inactive look-alike) gave the Adrenomedullin group a baseline to be compared against.
More than one site took part, so the patients came from several places.
What Was Measured
High plasma concentrations of ADM correlate with worse outcome in sepsis patients.
PubMed files the paper under topics including Adrenomedullin, Antibodies, Proof of Concept Study, Shock, Septic, Clinical Trials, Phase II as Topic and Randomized Controlled Trials as Topic.
The authors tagged it with the keywords adrecizumab, phase Ii clinical trial, sepsis, septic shock and vascular integrity.
What This Means in Plain Language
The paper is a randomized, double-blind and placebo-controlled study of Adrenomedullin in 300 patients.
With several hundred people or more, it is a fairly large study for this kind of research.
The publication is from 2019 (BMJ open), a journal based in England.
More context: the Adrenomedullin compound page, all human trials.
Our Notes on the Compound
Adrenomedullin: A 52-amino-acid peptide that widens blood vessels; studied as an infusion in heart, lung and gut conditions.
Related Pages
Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.