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
|Condition or disease||Intervention/treatment|
|Covid19||Device: IB10 sphingotest® bio-ADM® apparatus (Sphingotec GmbH, Hennigsdorf, Germany)|
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.
|Study Type :||Observational|
|Estimated Enrollment :||65 participants|
|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|
- 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.
- Mortality [ Time Frame: 28-days ]28-day mortality will be assessed
- Sequential Organ Failure Assessment (SOFA) Score and its changes over time [ Time Frame: 28-days ]Occurrence of multiorgan failure expressed in SOFA scores
- Need for catecholamines [ Time Frame: 28-days ]Need for catecholamines (drug, highest/lowest dose, duration)
- Need for renal replacement therapy [ Time Frame: 28-days ]Need for renal replacement therapy (duration)
- Need for mechanical ventilation [ Time Frame: 28-days ]Need for mechanical ventilation (duration)
- 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
- Changes in D-dimer [ Time Frame: 28-days ]Changes in D-dimer (in ng/ml)
- Changes in blood lactate levels [ Time Frame: 28-days ]Changes in blood lactate levels (in mg/dl)
- Changes C reactive protein (CRP) [ Time Frame: 28-days ]Changes CRP (in mg/l)
- Changes in procalcitonin levels [ Time Frame: 28-days ]Changes in procalcitonin levels (in ng/ml)
- Changes in creatinine levels [ Time Frame: 28-days ]Changes in creatinine levels (in mg/dl)
- 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
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
|Contact: Paweł Zatorski, MDfirstname.lastname@example.org|
|Medical University of Warsaw||Recruiting|
|Warszawa, Poland, 05-002|
|Contact: Paweł Zatorski, MD +48225021721 email@example.com|
|Principal Investigator:||Paweł Zatorski, MD||Medical University of Warsaw|