MR-proADM and CT-proET-1 During ICU Treatment

NCT03651635 | Completed

• 1 other identifier: proADM
• Study Type: observational
• Target: 533
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot-study will be a prospective, single-centre, observational study including 100 critically ill patients consecutively admitted to the medical intensive care unit (ICU) of the University hospital of Zurich, Switzerland, to assess and validate the use of MR-proADM and the CT-proET1/MR-proADM-ratio as prognostic markers in critically ill patients.

Conditions

Acute Phase Biomarkers; Medical ICU Admitted Patients

Keywords

ICU; Biomarkers

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve (AUROCCs) for MR-proADM

  Area under the concentration-time curve (AUROCCs) over 7 days for MR-proADM grouped by SOFA-Score ≥ 7 on day 7

  7 days

• Area under the concentration-time curve (AUROCCs) for the CT-proET-1/MR-proADM-ratio

  Area-under the concentration-time-curve (AUROCCs) over 7 days for the CT-proET-1/MR-proADM-ratio grouped by SOFA-Score ≥ 7 on day 7

  7 days

Secondary Outcomes (12)

• Correlation between area under the concentration-time curve for MR-proADM and microcirculation status

  7 days

• Correlation between area under the concentration-time curve for the CT-proET1/MR-proADM-ratio and microcirculation status

  7 days

• Correlation between area under the concentration-time curve for MR-proADM and cardiac biomarkers

  7 days

• Correlation between area under the concentration-time curve for the CT-proET1/MR-proADM-ratio and cardiac biomarkers

  7 days

• Correlation between area under the concentration-time curve for MR-proADM and biomarkers of inflammation

  7 days

Study Arms (1)

Medical ICU Patients

All patients admitted to the medical intensive care unit of the University hospital of Zurich during the recruitment period

Diagnostic Test: Blood sampling for MR-proADM & CT-proET-1

Interventions

Blood sampling for MR-proADM & CT-proET-1 DIAGNOSTIC_TEST

Collection of at most 8 blood samples (3ml each) per Patient admitted to the study and sampling for MR-proADM \& CT-proET-1

Medical ICU Patients

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 to the medical intensive care unit of the University hospital of Zurich during the recruitment period

You may qualify if:

• All patients admitted to the medical intensive care unit of the University hospital of Zurich during the recruitment period
• Male and female participants ≥ 18 years
• Written informed consent by the participant after information about the research project or if the patient is incapable of giving informed consent, a legal representative has confirmed the presumed will of the participant (according Art. 15 KlinV emergency patients)

You may not qualify if:

• Inability of the conscious patients to follow the experimental procedure, e.g. because of insufficient language skills (German), mental illness, dementia etc.
• Pregnancy
• Participation in ongoing clinical trials of other departments of the University Hospital Zurich

Sponsors & Collaborators

• University of Zurich: lead
• ThermoFisher Scientific Brahms Biomarkers France: collaborator

Study Sites (1)

University Hospital Zurich, Medical intensive care unit

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (40)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

During the process of the study we will collect at most 8 additional blood samples (3ml each). The collection of the blood samples will be paired with routine laboratory checks. All other parameters (health related personal data, comorbidities, values of hemodynamic will be reviewed from the chart or evaluated in line with routine daily investigations.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Marco Maggiorini, MD

  University Zürich/ University Hospital Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 29, 2018
• Study Start: January 8, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)