Fatal Outcome Clinical Trial
— ADRISKOfficial title:
A Prospective Clinical Trial of the Efficacy of Mid-regional Proadrenomedullin in the Triage and Multi-dimensional Risk Assessment of Patients Admitted to the Emergency Department
Verified date | March 2017 |
Source | University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study ia aiming to the assessment of Mid-Regional proadrenomedullin (MR-proADM) as a novel biomarker that can provide accurate short-, mid- and long term prognostic information in the triage and multi-dimensional risk assessment of patients in the Emergency Department (ED). A clinical algorithm with predefined MR-proADM cut-off values: <0.75 nmol/L (low risk), 0.75 nmol/L≥ and ≤ 1.5 nmol/L (intermediate risk); >1.5 nmol/L is pre-defined. Based on these cut-off values, a prespecified algorithm aiming to predict i) reduction of hospitalization in the ward/ICU and increase of out-patient treatment (rule-out of risk); and ii) reduce adverse complications (identify patients at risk) will be applied and compared with the initial clinical decision.
Status | Completed |
Enrollment | 300 |
Est. completion date | December 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age more than or equal to 18 years - Written informed consent provided by the patient Exclusion Criteria: High-risk for death the first 24 hours post admission i.e. moribund patients unlikely to thrive as defined by the attending physicians |
Country | Name | City | State |
---|---|---|---|
Greece | 4th Department of Internal Medicine, ATTIKON University Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
University of Athens |
Greece,
Haaf P, Twerenbold R, Reichlin T, Faoro J, Reiter M, Meune C, Steuer S, Bassetti S, Ziller R, Balmelli C, Campodarve I, Zellweger C, Kilchenmann A, Irfan A, Papassotiriou J, Drexler B, Mueller C. Mid-regional pro-adrenomedullin in the early evaluation of acute chest pain patients. Int J Cardiol. 2013 Sep 30;168(2):1048-55. doi: 10.1016/j.ijcard.2012.10.025. — View Citation
Nickel CH, Messmer AS, Geigy N, Misch F, Mueller B, Dusemund F, Hertel S, Hartmann O, Giersdorf S, Bingisser R. Stress markers predict mortality in patients with nonspecific complaints presenting to the emergency department and may be a useful risk stratification tool to support disposition planning. Acad Emerg Med. 2013 Jul;20(7):670-9. doi: 10.1111/acem.12172. — View Citation
Schuetz P, Marlowe RJ, Mueller B. The prognostic blood biomarker proadrenomedullin for outcome prediction in patients with chronic obstructive pulmonary disease (COPD): a qualitative clinical review. Clin Chem Lab Med. 2015 Mar;53(4):521-39. doi: 10.1515/cclm-2014-0748. Review. — View Citation
Schuetz P, Wolbers M, Christ-Crain M, Thomann R, Falconnier C, Widmer I, Neidert S, Fricker T, Blum C, Schild U, Morgenthaler NG, Schoenenberger R, Henzen C, Bregenzer T, Hoess C, Krause M, Bucher HC, Zimmerli W, Mueller B; ProHOSP Study Group.. Prohormones for prediction of adverse medical outcome in community-acquired pneumonia and lower respiratory tract infections. Crit Care. 2010;14(3):R106. doi: 10.1186/cc9055. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ProADM for risk prediction | Analysis of a predefined algorithm by MR-proADM cut-off values (<0.75 nmol/L as low risk, 0.75 nmol/L= and = 1.5 nmol/L as intermediate risk and >1.5 nmol/L as high-risk) to rule-out the risk of unfavorable outcome. | 28 days | |
Secondary | proADM for final diagnosis | To analyze a predifined algorithm of MR-proAMD and to evaluate relationship with final diagnosis | 28 days | |
Secondary | ProADM for risk prediction in real-life | To analyze a predifined algorithm of MR-proAMD trying to develop an algorithm for decision-making in real-life | 28 days | |
Secondary | proADM as predictor of outcome | To analyze a predifined algorithm of MR-proAMD trying to answer if it is an independent predictor of final outcome based on multivariate models | 28 days |
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