Clinical trial NCT04813939: Is Bio-adrenomedullin (Bio-ADM) a Prognostic Factor in Patients With COVID-19 Treated in the ICU?
Official title: Is Bio-adrenomedullin (Bio-ADM) a Prognostic Factor in Patients With COVID-19 Treated in the ICU?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Covid19
Keywords: bio-adrenomedullin
point of care
sepsis
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Mortality
timeFrame: 28-days
Secondary outcomes:
measure: Sequential Organ Failure Assessment (SOFA) Score and its changes over time
timeFrame: 28-days
measure: Need for catecholamines
timeFrame: 28-days
measure: Need for renal replacement therapy
timeFrame: 28-days
measure: Need for mechanical ventilation
timeFrame: 28-days
measure: Changes of partial pressure of oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) during treatment in ICU
timeFrame: 28-days
measure: Changes in D-dimer
timeFrame: 28-days
measure: Changes in blood lactate levels
timeFrame: 28-days
measure: Changes C reactive protein (CRP)
timeFrame: 28-days
measure: Changes in procalcitonin levels
timeFrame: 28-days
measure: Changes in creatinine levels
timeFrame: 28-days
Other outcomes:
measure: Sepsis complicating the course of COVID-19 during ICU treatment
timeFrame: 28-days
Locations:
city: Warszawa
country: Poland
facility: Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Paweł Zatorski, MD
role: PRINCIPAL_INVESTIGATOR
References: