Acute Phase BiomarkersMR-proADMNCT03651635
MR-proADM and CT-proET-1 During ICU Treatment
An observational study of Acute Phase Biomarkers and Medical ICU Admitted Patients, run by University of Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Phase Biomarkers, Medical ICU Admitted Patients
- What is being tested?
- Blood sampling for MR-proADM & CT-proET-1
- How many people
- 533 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Jan 2018to 28 Feb 2019
- 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 to the medical intensive care unit of the University hospital of Zurich during the recruitment period
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Medical intensive care unit
Zurich, Canton of Zurich, 8091
About this study
Official title: 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.
Read the 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.
- Being tested
- Blood sampling for MR-proADM & CT-proET-1
- Keywords
- ICU, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling for MR-proADM & CT-proET-1Diagnostic test
Collection of at most 8 blood samples (3ml each) per Patient admitted to the study and sampling for MR-proADM \& CT-proET-1
| Study group | Role | What they receive |
|---|---|---|
| Medical ICU Patients | All patients admitted to the medical intensive care unit of the University hospital of Zurich during the recruitment period Receives: Diagnostic Test: Blood sampling for MR-proADM & CT-proET-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 7 days
Secondary outcomes (12)
Correlation between area under the concentration-time curve for MR-proADM and microcirculation status
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
Measured: 7 days
Correlation between area under the concentration-time curve for the CT-proET1/MR-proADM-ratio and microcirculation status
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
Measured: 7 days
Correlation between area under the concentration-time curve for MR-proADM and cardiac biomarkers
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
Measured: 7 days
Correlation between area under the concentration-time curve for the CT-proET1/MR-proADM-ratio and cardiac biomarkers
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
Measured: 7 days
Correlation between area under the concentration-time curve for MR-proADM and biomarkers of inflammation
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
Measured: 7 days
Correlation between area under the concentration-time curve for the CT-proET-1/MR-proADM-ratio and biomarkers of inflammation
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
Measured: 7 days
Correlation between area under the concentration-time curve for MR-proADM and renal dysfunction
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
Measured: 7 days
Correlation between area under the concentration-time curve for the CT-proET1/MR-proADM-ratio and renal dysfunction
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
Measured: 7 days
Admission plasma levels of MR-proADM as a predictor of multiorgan dysfunction
Admission plasma levels of MR-proADM as a predictor of multiorgan dysfunction (SOFA-Score ≥ 7) on day 7 of ICU treatment (ROC-AUC)
Measured: 7 days
Admission plasma levels of the CT-proET1/MR-proADM-ratio as a predictor of multiorgan dysfunction
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)
Measured: 7 days
AUROCCs for MR-proADM during the first 7 days of ICU treatment as predictors of mortality
AUROCCs for MR-proADM during the first 7 days of ICU treatment as predictors of mortality on day 7, 28 and hospital-mortality
Measured: 28 days
AUROCCs for the MR-proADM/CT-proET-1-ratio during the first 7 days of ICU treatment as predictors of mortality
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start8 Jan 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Acute Phase BiomarkersStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 533 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- ThermoFisher Scientific Brahms Biomarkers France
- Responsible party
- Sponsor
- Investigators
- Marco Maggiorini, MD, Principal investigator, University Zürich/ University Hospital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651635
- Sponsor's protocol ID
- proADM
- Acronym
- MR-proADM
- Status last verified
- May 2021
- First submitted
- 23 Aug 2018
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Espana PP, Capelastegui A, Quintana JM, Bilbao A, Diez R, Pascual S, Esteban C, Zalacain R, Menendez R, Torres A. Validation and comparison of SCAP as a predictive score for identifying low-risk patients in community-acquired pneumonia. J Infect. 2010 Feb;60(2):106-13. doi: 10.1016/j.jinf.2009.11.013. Epub 2009 Dec 2.
PubMed 19961875Fine MJ, Auble TE, Yealy DM, Hanusa BH, Weissfeld LA, Singer DE, Coley CM, Marrie TJ, Kapoor WN. A prediction rule to identify low-risk patients with community-acquired pneumonia. N Engl J Med. 1997 Jan 23;336(4):243-50. doi: 10.1056/NEJM199701233360402.
PubMed 8995086Lim WS, van der Eerden MM, Laing R, Boersma WG, Karalus N, Town GI, Lewis SA, Macfarlane JT. Defining community acquired pneumonia severity on presentation to hospital: an international derivation and validation study. Thorax. 2003 May;58(5):377-82. doi: 10.1136/thorax.58.5.377.
PubMed 12728155Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
PubMed 3928249Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA. 1993 Dec 22-29;270(24):2957-63. doi: 10.1001/jama.270.24.2957.
PubMed 8254858Ferreira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA. 2001 Oct 10;286(14):1754-8. doi: 10.1001/jama.286.14.1754.
PubMed 11594901Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016.
PubMed 9824069Pierrakos C, Vincent JL. Sepsis biomarkers: a review. Crit Care. 2010;14(1):R15. doi: 10.1186/cc8872. Epub 2010 Feb 9.
PubMed 20144219Hinson JP, Kapas S, Smith DM. Adrenomedullin, a multifunctional regulatory peptide. Endocr Rev. 2000 Apr;21(2):138-67. doi: 10.1210/edrv.21.2.0396.
PubMed 10782362Eto T. A review of the biological properties and clinical implications of adrenomedullin and proadrenomedullin N-terminal 20 peptide (PAMP), hypotensive and vasodilating peptides. Peptides. 2001 Nov;22(11):1693-711. doi: 10.1016/s0196-9781(01)00513-7.
PubMed 11754955Morgenthaler NG, Struck J, Alonso C, Bergmann A. Measurement of midregional proadrenomedullin in plasma with an immunoluminometric assay. Clin Chem. 2005 Oct;51(10):1823-9. doi: 10.1373/clinchem.2005.051110. Epub 2005 Aug 11.
PubMed 16099941Papassotiriou J, Morgenthaler NG, Struck J, Alonso C, Bergmann A. Immunoluminometric assay for measurement of the C-terminal endothelin-1 precursor fragment in human plasma. Clin Chem. 2006 Jun;52(6):1144-51. doi: 10.1373/clinchem.2005.065581. Epub 2006 Apr 20.
PubMed 16627560Albrich WC, Dusemund F, Ruegger K, Christ-Crain M, Zimmerli W, Bregenzer T, Irani S, Buergi U, Reutlinger B, Mueller B, Schuetz P. Enhancement of CURB65 score with proadrenomedullin (CURB65-A) for outcome prediction in lower respiratory tract infections: derivation of a clinical algorithm. BMC Infect Dis. 2011 May 3;11:112. doi: 10.1186/1471-2334-11-112.
PubMed 21539743Albrich WC, Ruegger K, Dusemund F, Schuetz P, Arici B, Litke A, Blum CA, Bossart R, Regez K, Schild U, Guglielmetti M, Conca A, Schafer P, Schubert M, de Geest S, Reutlinger B, Irani S, Burgi U, Huber A, Muller B. Biomarker-enhanced triage in respiratory infections: a proof-of-concept feasibility trial. Eur Respir J. 2013 Oct;42(4):1064-75. doi: 10.1183/09031936.00113612. Epub 2013 Jan 24.
PubMed 23349444Bello S, Lasierra AB, Minchole E, Fandos S, Ruiz MA, Vera E, de Pablo F, Ferrer M, Menendez R, Torres A. Prognostic power of proadrenomedullin in community-acquired pneumonia is independent of aetiology. Eur Respir J. 2012 May;39(5):1144-55. doi: 10.1183/09031936.00080411. Epub 2011 Nov 10.
PubMed 22075489
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03651635
- Acronym / sponsor ID
- MR-proADM / proADM
- Keywords
- ICU, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 533 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- ThermoFisher Scientific Brahms Biomarkers France
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical ICU Patients | – | Diagnostic Test: Blood sampling for MR-proADM & CT-proET-1All patients admitted to the medical intensive care unit of the University hospital of Zurich during the recruitment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the medical intensive care unit of the University hospital of Zurich during the recruitment period
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling for MR-proADM & CT-proET-1Collection of at most 8 blood samples (3ml each) per Patient admitted to the study and sampling for MR-proADM \& CT-proET-1 | Diagnostic test | Medical ICU Patients |
Primary outcome
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
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
12 secondary outcomes
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 the CT-proET1/MR-proADM-ratio and microcirculation status
Time frame: 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 the CT-proET1/MR-proADM-ratio and cardiac biomarkers
Time frame: 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 the CT-proET-1/MR-proADM-ratio and biomarkers of inflammation
Time frame: 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 the CT-proET1/MR-proADM-ratio and renal dysfunction
Time frame: 7 days
Admission plasma levels of MR-proADM 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
Time frame: 7 days
AUROCCs for MR-proADM 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
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Background: PubMed 19961875Espana PP, Capelastegui A, Quintana JM, Bilbao A, Diez R, Pascual S, Esteban C, Zalacain R, Menendez R, Torres A. Validation and comparison of SCAP as a predictive score for identifying low-risk patients in community-acquired pneumonia. J Infect. 2010 Feb;60(2):106-13. doi: 10.1016/j.jinf.2009.11.013. Epub 2009 Dec 2.
- Background: PubMed 8995086Fine MJ, Auble TE, Yealy DM, Hanusa BH, Weissfeld LA, Singer DE, Coley CM, Marrie TJ, Kapoor WN. A prediction rule to identify low-risk patients with community-acquired pneumonia. N Engl J Med. 1997 Jan 23;336(4):243-50. doi: 10.1056/NEJM199701233360402.
- Background: PubMed 12728155Lim WS, van der Eerden MM, Laing R, Boersma WG, Karalus N, Town GI, Lewis SA, Macfarlane JT. Defining community acquired pneumonia severity on presentation to hospital: an international derivation and validation study. Thorax. 2003 May;58(5):377-82. doi: 10.1136/thorax.58.5.377.
- Background: PubMed 3928249Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
- Background: PubMed 8254858Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA. 1993 Dec 22-29;270(24):2957-63. doi: 10.1001/jama.270.24.2957.
- Background: PubMed 11594901Ferreira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA. 2001 Oct 10;286(14):1754-8. doi: 10.1001/jama.286.14.1754.
- Background: PubMed 9824069Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016.
- Background: PubMed 20144219Pierrakos C, Vincent JL. Sepsis biomarkers: a review. Crit Care. 2010;14(1):R15. doi: 10.1186/cc8872. Epub 2010 Feb 9.
- Background: PubMed 10782362Hinson JP, Kapas S, Smith DM. Adrenomedullin, a multifunctional regulatory peptide. Endocr Rev. 2000 Apr;21(2):138-67. doi: 10.1210/edrv.21.2.0396.
- Background: PubMed 11754955Eto T. A review of the biological properties and clinical implications of adrenomedullin and proadrenomedullin N-terminal 20 peptide (PAMP), hypotensive and vasodilating peptides. Peptides. 2001 Nov;22(11):1693-711. doi: 10.1016/s0196-9781(01)00513-7.
- Background: PubMed 16099941Morgenthaler NG, Struck J, Alonso C, Bergmann A. Measurement of midregional proadrenomedullin in plasma with an immunoluminometric assay. Clin Chem. 2005 Oct;51(10):1823-9. doi: 10.1373/clinchem.2005.051110. Epub 2005 Aug 11.
- Background: PubMed 16627560Papassotiriou J, Morgenthaler NG, Struck J, Alonso C, Bergmann A. Immunoluminometric assay for measurement of the C-terminal endothelin-1 precursor fragment in human plasma. Clin Chem. 2006 Jun;52(6):1144-51. doi: 10.1373/clinchem.2005.065581. Epub 2006 Apr 20.
- Individual participant dataSharing planned: No
Related trials for Acute Phase Biomarkers
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
RecruitingObservational study
Critical Hyperacute Assessment Research On Neurobiomarker Kinetics in Acute Brain Injury
Brain Injuries, Traumatic, Brain Injuries, Acute
RecruitingPhase 3
Clinical Trial With Aprotinin in the Acute Respiratory Distress Syndrome Treatment
Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 2
Randomised Treatment of Acute Pancreatitis With Infliximab: Double-blind, Placebo-controlled, Multi-centre Trial (RAPID-I)
Acute Pancreatitis
Recruiting
IVR ON UPPER-LIMB REHABILITATION IN STROKE PATIENTS: A CLINICAL TRIAL
Stroke Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Maggiorini, MD principal investigator
University Zürich/ University Hospital Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Phase Biomarkers and Medical ICU Admitted Patients, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 3 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 2 Jun 2021. 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 Switzerland. 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?
Area under the concentration-time curve (AUROCCs) for MR-proADM (time frame: 7 days). The study lists 2 primary outcomes in all. 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 NCT03651635, which also lists 40 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 2 Jun 2021.