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

May 27, 2021 updated by: University of Zurich

To Assess and Validate the Use of MR-proADM and the CT-proET-1/MR-proADM Ratio as Prognostic Markers During the First 7 Days of ICU Treat-ment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. After obtaining informed consent of the patient or approval of a legal representative and meeting of the inclusion, as well as missing exclusion criteria the patients will be enrolled.

At study enrolment patient health status will be assessed by health related diagnosis and the Charlson comorbidity index. This information is obtained routinely in every patient in our ICU. The Charlson comorbidity index is calculated based on the medical history of the patient. The values of MR-proADM and CT-proET-1 will be measured daily over the first 7 days of the ICU stay. If a patient is discharged before day 7, no further measurements will be performed. The blood samples will be collected together with the routine blood check on admission, as well as each morning. Clinical evaluation of the patients will take place each morning including the evaluation of the hemodynamics, organ dysfunction, microcirculation and the need for vasopressors.

The severity of illness of the patient will be assessed using the SAPS II score and the SOFA score. SAPS-II reflects the physiological status of the patient within the first 24 hours (admission severity) and the SOFA score the number of failing organs (respiration, coagulation, liver, cardiovascular, CNS, renal). The SAPS-II will be assessed on Visit 3 and the SOFA daily using the information obtained during the routine clinical examination and the laboratory results of the day. SAPS II and SOFA scores are part of the routine assessment of all our patients in the ICU and are used as quality indicators.

The status of the microcirculation is assessed using clinical signs (mottling score, capillary refill time and sublingual microcirculation functional status) and laboratory parameters reflecting the degree of tissue oxygen extraction such as SaO2-SvO2 gap, Pv-aCO2 gap and the arterial lactate concentration. All these parameters are delivered by the blood gas analyser located in the ICU from an arterial and a venous blood sample of 1.5 ml each drawn via the arterial and central venous line respectively. These catheters and blood samples are part of the routine hemo-dynamic monitoring and assessment of the critically ill patient in our ICU.

The patients' survival status will be assessed on day 7 and day 28 after study enrolment. In addition, ICU and hospital mortality are recorded. If the patient is still in the hospital on day 28, survival data will be taken from the medical record. In the case the patient is dismissed from the hospital the study team will contact him by phone call. If he is not reachable (documented attempts) the study team will contact his general practitioner. To be in line with data protection requirements the patient gives the consent to contact the general practitioner in the informed consent form. No other information than the survival status will be collected at this stage. Data collection for the study ends 28 (± 3 days) days after enrolment.

Study Type

Observational

Enrollment (Actual)

533

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Medical intensive care unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the concentration-time curve (AUROCCs) for MR-proADM
Time Frame: 7 days
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
Time Frame: 7 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between area under the concentration-time curve for MR-proADM and microcirculation status
Time Frame: 7 days
Correlation between area under the concentration-time curve for MR-proADM and microcirculation status (mottling score, capillary refill time, sublingual microcirculation functional status) on day 7
7 days
Correlation between area under the concentration-time curve for the CT-proET1/MR-proADM-ratio and microcirculation status
Time Frame: 7 days
Correlation between area under the concentration-time curve for the CT-proET1/MR-proADM-ratio and microcirculation status (mottling score, capillary refill time, sublingual microcirculation functional status) on day 7
7 days
Correlation between area under the concentration-time curve for MR-proADM and cardiac biomarkers
Time Frame: 7 days
Correlation between area under the concentration-time curve for MR-proADM and cardiac biomarkers (NT-proBNP, Troponin T) during the first 7 days of ICU stay
7 days
Correlation between area under the concentration-time curve for the CT-proET1/MR-proADM-ratio and cardiac biomarkers
Time Frame: 7 days
Correlation between area under the concentration-time curve for the CT-proET1/MR-proADM-ratio and cardiac biomarkers (NT-proBNP, Troponin T) during the first 7 days of ICU stay
7 days
Correlation between area under the concentration-time curve for MR-proADM and biomarkers of inflammation
Time Frame: 7 days
Correlation between area under the concentration-time curve for MR-proADM and biomarkers of inflammation (C-reactive protein, procalcitonin, interleukin-6) during the first 7 days of ICU stay
7 days
Correlation between area under the concentration-time curve for the CT-proET-1/MR-proADM-ratio and biomarkers of inflammation
Time Frame: 7 days
Correlation between area under the concentration-time curve for the CT-proET-1/MR-proADM-ratio and biomarkers of inflammation (C-reactive protein, procalcitonin, interleukin-6) during the first 7 days of ICU stay
7 days
Correlation between area under the concentration-time curve for MR-proADM and renal dysfunction
Time Frame: 7 days
Correlation between area under the concentration-time curve for MR-proADM and renal dysfunction (AKI defined by KDIGO-Classification) on day 7 or ICU discharge
7 days
Correlation between area under the concentration-time curve for the CT-proET1/MR-proADM-ratio and renal dysfunction
Time Frame: 7 days
Correlation between area under the concentration-time curve for the CT-proET1/MR-proADM-ratio and renal dysfunction (AKI defined by KDIGO-Classification) on day 7 or ICU discharge
7 days
Admission plasma levels of MR-proADM as a predictor of multiorgan dysfunction
Time Frame: 7 days
Admission plasma levels of MR-proADM as a predictor of multiorgan dysfunction (SOFA-Score ≥ 7) on day 7 of ICU treatment (ROC-AUC)
7 days
Admission plasma levels of the CT-proET1/MR-proADM-ratio as a predictor of multiorgan dysfunction
Time Frame: 7 days
Admission plasma levels of the CT-proET1/MR-proADM-ratio as a predictor of multiorgan dysfunction (SOFA-Score ≥ 7) on day 7 of ICU treatment (ROC-AUC)
7 days
AUROCCs for MR-proADM during the first 7 days of ICU treatment as predictors of mortality
Time Frame: 28 days
AUROCCs for MR-proADM during the first 7 days of ICU treatment as predictors of mortality on day 7, 28 and hospital-mortality
28 days
AUROCCs for the MR-proADM/CT-proET-1-ratio during the first 7 days of ICU treatment as predictors of mortality
Time Frame: 28 days
AUROCCs for the MR-proADM/CT-proET-1-ratio during the first 7 days of ICU treatment as predictors of mortality on day 7, 28 and hospital-mortality
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

ThermoFisher Scientific Brahms Biomarkers France

Investigators

  • Principal Investigator: Marco Maggiorini, MD, University Zürich/ University Hospital Zürich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 8, 2018

Primary Completion (ACTUAL)

February 28, 2019

Study Completion (ACTUAL)

February 28, 2019

Study Registration Dates

First Submitted

August 23, 2018

First Submitted That Met QC Criteria

August 28, 2018

First Posted (ACTUAL)

August 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2021

Last Update Submitted That Met QC Criteria

May 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • proADM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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