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Is Bio-adrenomedullin (Bio-ADM) a Prognostic Factor in Patients With COVID-19 Treated in the ICU?

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ClinicalTrials.gov Identifier: NCT04813939
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

Brief Summary:
This is prospective, observational study using point of care test to determine bio-ADM whole blood concentrations and its predictive value in patients with COVID-19 treated in the ICU.

Condition or disease Intervention/treatment
Covid19 Device: IB10 sphingotest® bio-ADM® apparatus (Sphingotec GmbH, Hennigsdorf, Germany)

Detailed Description:

About 5% of all patients infected with the SARS-CoV-2 virus require treatment in the ICU. The main reason for admission to the ICU is acute hypoxemic respiratory failure, which in most cases is associated with the need for mechanical ventilation. The progression of lung damage affects not only alveoli but also endothelium of the pulmonary vessels. Occurring endotheliopathy is caused by direct infection with SARS-CoV-2 virus and activation of the immune system leading to an increased inflammatory reaction. Damage to the endothelium barrier with concomitant cytokine storm lead to activation of the coagulation system and formation of microthrombotic events in the vascular bed, resulting in thromboembolic complications and development of multiorgan failure. The reflection of the above pathophysiological phenomena in laboratory tests is a significant increase in the concentration of D-dimers. At present, no specific markers of endotheliopathy in patients with SARS-CoV-2 are known.

Adrenomedullin (ADM) is a peptide hormone that plays a key role in regulating the function of the endothelium, by modulating its integrity and permeability, it also has an effect on the vascular muscle, leading to vasodilation. Recently, the role of ADM has been intensively studied, including in sepsis. Several studies have confirmed an association between elevated ADM levels and poor prognosis in sepsis and septic shock. In these studies, measurements of various adrenomedullin precursors and free, biologically active adrenomedullin (bio-adrenomedullin, bio-ADM) were performed. The role of bio-ADM in the course of COVID -19 remains unclear.

The aim of the study is to determine the baseline concentration of bio-ADM and to determine the dynamic of the concentration changes in three measurements in patients with COVID-19 during ICU treatment. Additional measurement of bio-ADM will be performed as standard monitoring in patients suspected of septic complications of the course of COVID-19.

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Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Bio-adrenomedullin (Bio-ADM) a Prognostic Factor in Patients With COVID-19 Treated in the ICU?
Actual Study Start Date : March 22, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 31, 2022

Intervention Details:
  • Device: IB10 sphingotest® bio-ADM® apparatus (Sphingotec GmbH, Hennigsdorf, Germany)
    Point of care assessment of bio-adrenomedullin concentration will be performed using the IB10 sphingotest® bio-ADM® apparatus (Sphingotec GmbH, Hennigsdorf, Germany) on the 1,3,5-day ICU stay in COVID-19 patients. The method used is a double monoclonal sandwich immunoassay to measure the concentration of C-terminal amidated, biologically active adrenomedullin (bio-ADM) in whole blood. Additional measurement of bio-ADM will be performed as standard monitoring in patients suspected of septic complications of the course of COVID-19.


Primary Outcome Measures :
  1. Mortality [ Time Frame: 28-days ]
    28-day mortality will be assessed


Secondary Outcome Measures :
  1. Sequential Organ Failure Assessment (SOFA) Score and its changes over time [ Time Frame: 28-days ]
    Occurrence of multiorgan failure expressed in SOFA scores

  2. Need for catecholamines [ Time Frame: 28-days ]
    Need for catecholamines (drug, highest/lowest dose, duration)

  3. Need for renal replacement therapy [ Time Frame: 28-days ]
    Need for renal replacement therapy (duration)

  4. Need for mechanical ventilation [ Time Frame: 28-days ]
    Need for mechanical ventilation (duration)

  5. Changes of partial pressure of oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) during treatment in ICU [ Time Frame: 28-days ]
    PaO2/FiO2

  6. Changes in D-dimer [ Time Frame: 28-days ]
    Changes in D-dimer (in ng/ml)

  7. Changes in blood lactate levels [ Time Frame: 28-days ]
    Changes in blood lactate levels (in mg/dl)

  8. Changes C reactive protein (CRP) [ Time Frame: 28-days ]
    Changes CRP (in mg/l)

  9. Changes in procalcitonin levels [ Time Frame: 28-days ]
    Changes in procalcitonin levels (in ng/ml)

  10. Changes in creatinine levels [ Time Frame: 28-days ]
    Changes in creatinine levels (in mg/dl)


Other Outcome Measures:
  1. Sepsis complicating the course of COVID-19 during ICU treatment [ Time Frame: 28-days ]
    Occurrence of sepsis complicating the course of COVID-19 during ICU treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All consecutive patients from emergency department and intermediate department meeting the eligibility criteria will be enrolled to the study.
Criteria

Inclusion Criteria:

  • age ≥ 18 years
  • polymerase chain reaction (PCR) confirmed COVID-19
  • severe stage of pneumonia caused by SARS-CoV-2 requiring oxygen therapy
  • informed consent to participate in the study

Exclusion Criteria:

  • qualification to palliative care
  • life expectancy < 48 h
  • mechanical ventilation at the beginning of the hospitalization
  • transfer from other ICU
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04813939


Contacts
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Contact: Paweł Zatorski, MD +48225021721 pzatorski@wum.edu.pl

Locations
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Poland
Medical University of Warsaw Recruiting
Warszawa, Poland, 05-002
Contact: Paweł Zatorski, MD    +48225021721    pzatorski@wum.edu.pl   
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Paweł Zatorski, MD Medical University of Warsaw
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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT04813939    
Other Study ID Numbers: 042021
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Warsaw:
bio-adrenomedullin
point of care
sepsis