Proadrenomedullin for Early Risk Assessment in the Emergency Department

NCT02823704 | Completed

• 1 other identifier: 01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Fatal Outcome

Keywords

Sepsis; Chest pain; Abdominal pain; Electrolyte disturbances; Stroke; Triage; Risk for death

Outcome Measures

Primary Outcomes (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.

  28 days

Secondary Outcomes (3)

• proADM for final diagnosis

  28 days

• ProADM for risk prediction in real-life

  28 days

• proADM as predictor of outcome

  28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

4th Department of Internal Medicine, ATTIKON University Hospital

Athens, 12462, Greece

Location

Related Publications (4)

• 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.

  PMID: 20529344 BACKGROUND

• 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.

  PMID: 25252756 BACKGROUND

• 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.

  PMID: 23859580 BACKGROUND

• 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.

  PMID: 23199555 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples on study enrolment

MeSH Terms

Conditions

Sepsis; Chest Pain; Abdominal Pain; Stroke

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Evangelos Giamarellos-Bourboulis, MD, PhD

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 6, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 20, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)