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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04813939
• Other study ID #: 042021
• Status: Terminated
• Start date: March 22, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: March 2021
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warszawa

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sepsis complicating the course of COVID-19 during ICU treatment	Occurrence of sepsis complicating the course of COVID-19 during ICU treatment	28-days
Primary	Mortality	28-day mortality will be assessed	28-days
Secondary	Sequential Organ Failure Assessment (SOFA) Score and its changes over time	Occurrence of multiorgan failure expressed in SOFA scores	28-days
Secondary	Need for catecholamines	Need for catecholamines (drug, highest/lowest dose, duration)	28-days
Secondary	Need for renal replacement therapy	Need for renal replacement therapy (duration)	28-days
Secondary	Need for mechanical ventilation	Need for mechanical ventilation (duration)	28-days
Secondary	Changes of partial pressure of oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) during treatment in ICU	PaO2/FiO2	28-days
Secondary	Changes in D-dimer	Changes in D-dimer (in ng/ml)	28-days
Secondary	Changes in blood lactate levels	Changes in blood lactate levels (in mg/dl)	28-days
Secondary	Changes C reactive protein (CRP)	Changes CRP (in mg/l)	28-days
Secondary	Changes in procalcitonin levels	Changes in procalcitonin levels (in ng/ml)	28-days
Secondary	Changes in creatinine levels	Changes in creatinine levels (in mg/dl)	28-days