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AzTrials

Fatal OutcomeADRISKNCT02823704

Proadrenomedullin for Early Risk Assessment in the Emergency Department

An observational study of Fatal Outcome, run by University of Athens at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fatal Outcome
How many people
300 participants
Where
1 siteGreece
Study dates
Jun 2016to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients admitted in the emergency department of ATTIKON University General Hospital.

Who may be able to join

  • Age more than or equal to 18 years
  • Written informed consent provided by the patient

Who cannot join

  • High-risk for death the first 24 hours post admission i.e. moribund patients unlikely to thrive as defined by the attending physicians

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • 4th Department of Internal Medicine, ATTIKON University Hospital

    Athens, 12462

Other trials in Greece

About this study

Official 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

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.

Read the detailed description

Emergency departments (ED) are becoming increasingly over-crowded, with patients facing prolonged waiting times. This is further aggravated by the shortage of available hospital space. Therefore, a safe and rapid triaging of patients is essential in improving the workflow within the ED, maximizing patient safety and comfort, and alleviating any unnecessary financial burden from the healthcare provider.

Adrenomedullin (ADM), a 52 amino acid peptide, is a member of the calcitonin peptide family and is widely expressed in many tissues and organs. It has been shown to have a variety of physiological functions, including immune-modulating, direct bactericidal, diuretic and potent vasodilatory activity. In healthy subjects, ADM circulates at low picomolar concentrations. In many pathological states such as hypertension, renal failure, lower respiratory diseases and septic shock, plasma levels of adrenomedulin are significantly up-regulated in proportion to disease severity. These unique properties makes it a potentially useful marker in determination of the patients most at risk of developing complications on admission to the ED, in order to rapidly triage and administer the most effective treatment in the shortest possible time.

However, reliable measurement of ADM is challenging due to a number of issues, such as: a short half time of 22 minutes; rapid degradation by proteases; and binding to complement factor H. Therefore, the increased stability of its precursor molecule, Mid-Regional(MR)-proADM, allows it to be reliably measured as a surrogate biomarker for the unstable ADM in a 1:1 ratio. The aim of this study is the assessment of 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 ED setting.

ADM, present mainly in endothelial and vascular smooth muscle cells, can act as both a hormone and cytokine (often termed a "hormokine) in an autocrine and paracrine manner. Its potent vasodilatory and hypotensive response is elicited through an initial increase in cyclic adenosine monophosphate levels, and a subsequent production of nitric oxide. The importance of ADM in homeostasis is illustrated by its central role in the up- and down- regulation of cytokines and other mediators, as well as its own stimulatory and inhibitory effect on cytokine production. Indeed, interleukin (IL)-1β and tumor necrosis factor-alpha (TNFα) are two of the most potent triggers for ADM production. It is also up-regulated by hypoxia, bacterial products, such as lipopolysaccharide (LPS), and shear stress. Moreover, ADM has potent antimicrobial actions through membrane channel formation and lysis, and anti-apoptotic properties, it enhances renal excretion of sodium, decreases aldosterone synthesis and increases renal blood flow and urine volume. The ubiquitous and important functional role of ADM results in its clinical use in many diverse indications. Its precursor molecule, MR-proADM, has been shown to be a powerful risk assessment marker in sepsis and lower respiratory tract infections with the ability to predict 30 day mortality regardless of the underlying diagnosis. Plasma concentrations of MR-proADM have been also shown to be elevated in myocardial infarction, and to correlate with the severity of acute and chronic heart failure. Furthermore, it has been shown that it outperforms BNP and NT-BNP in predicting mortality in ED patients with dyspnea after 30 days8-12. MR-proADM is also elevated in various types of glomerulonephritis and progressively increased in patients with chronic renal failure (CKD) and has greater predictive accuracy in determining risk of CKD progression, compared to standard GFR measurements.

MR-proADM is determined in plasma EDTA samples by an automated immunofluorescent assay (Thermo ScientificTM BRAHMSTM MR-proADM KRYPTORTM). Healthy individuals have detectable levels of MR-proADM of approximately 0.4nmol/L. The functional assay sensitivity has been assessed as being 0.25 nmol/L. Levels of MR-proADM are not influenced by food or water intake and there are no significant gender-related differences, which optimize its use in risk assessment. Furthermore, it remains stable up to 72 hours in EDTA plasma at room temperature and over four freeze/ thaw cycles.

In a previous study, an algorithm has been validated using MR-proADM cut-off values together with clinical risk assessment by the ED physician. The application of this model could potentially lead to an increase of patients safely discharged from the hospital falling into the low risk category. It has been shown that the prognostic information of this model could enhance the appropriateness of disposition decisions of patients presenting to the ED with non-specific complaints (NSC).

Conditions
Fatal Outcome
Keywords
Sepsis, Chest pain, Abdominal pain, Electrolyte disturbances, Stroke, Triage, Risk for death
Medical subject headings
Sepsis, Chest Pain, Abdominal Pain, Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 28 days

Secondary outcomes (3)
  1. proADM for final diagnosis

    To analyze a predifined algorithm of MR-proAMD and to evaluate relationship with final diagnosis

    Measured: 28 days

  2. 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

    Measured: 28 days

  3. 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

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionOct 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02823704
Sponsor's protocol ID
01
Acronym
ADRISK
Status last verified
Mar 2017
First submitted
30 Jun 2016
Last updated
20 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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. Epub 2010 Jun 8.

    PubMed 20529344
  • 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.

    PubMed 25252756
  • 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.

    PubMed 23859580
  • 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. Epub 2012 Nov 27.

    PubMed 23199555

Questions about this trial

What is this clinical trial studying?

An observational study of Fatal Outcome, run by University of Athens at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ProADM for risk prediction (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02823704, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.

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