An observational study in Covid19, sponsored by Medical University of Warsaw. Terminated at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-16.
Sponsored by Medical University of Warsaw · Observational
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 32 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive patients from emergency department and intermediate department meeting the eligibility criteria will be enrolled to the study.
Exclusion Criteria:
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
28-day mortality will be assessed
Time frame: 28-days
Sequential Organ Failure Assessment (SOFA) Score and its changes over time
Occurrence of multiorgan failure expressed in SOFA scores
Time frame: 28-days
Need for catecholamines
Need for catecholamines (drug, highest/lowest dose, duration)
Time frame: 28-days
Need for renal replacement therapy
Need for renal replacement therapy (duration)
Time frame: 28-days
Need for mechanical ventilation
Need for mechanical ventilation (duration)
Time frame: 28-days
Changes of partial pressure of oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) during treatment in ICU
PaO2/FiO2
Time frame: 28-days
Changes in D-dimer
Changes in D-dimer (in ng/ml)
Time frame: 28-days
Changes in blood lactate levels
Changes in blood lactate levels (in mg/dl)
Time frame: 28-days
Changes C reactive protein (CRP)
Changes CRP (in mg/l)
Time frame: 28-days
Changes in procalcitonin levels
Changes in procalcitonin levels (in ng/ml)
Time frame: 28-days
Changes in creatinine levels
Changes in creatinine levels (in mg/dl)
Time frame: 28-days
Sepsis complicating the course of COVID-19 during ICU treatment
Occurrence of sepsis complicating the course of COVID-19 during ICU treatment
Time frame: 28-days
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Medical University of Warsaw