Is Bio-adrenomedullin (Bio-ADM) a Prognostic Factor in Patients With COVID-19 Treated in the ICU?
- Conditions
- Covid19
- Registration Number
- NCT04813939
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 32
- 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
- qualification to palliative care
- life expectancy < 48 h
- mechanical ventilation at the beginning of the hospitalization
- transfer from other ICU
- pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality 28-days 28-day mortality will be assessed
- Secondary Outcome Measures
Name Time Method Changes in blood lactate levels 28-days Changes in blood lactate levels (in mg/dl)
Need for renal replacement therapy 28-days Need for renal replacement therapy (duration)
Need for catecholamines 28-days Need for catecholamines (drug, highest/lowest dose, duration)
Need for mechanical ventilation 28-days Need for mechanical ventilation (duration)
Changes in D-dimer 28-days Changes in D-dimer (in ng/ml)
Changes C reactive protein (CRP) 28-days Changes CRP (in mg/l)
Changes in procalcitonin levels 28-days Changes in procalcitonin levels (in ng/ml)
Changes in creatinine levels 28-days Changes in creatinine levels (in mg/dl)
Sequential Organ Failure Assessment (SOFA) Score and its changes over time 28-days Occurrence of multiorgan failure expressed in SOFA scores
Changes of partial pressure of oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) during treatment in ICU 28-days PaO2/FiO2
Trial Locations
- Locations (1)
Medical University of Warsaw
🇵🇱Warszawa, Poland