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

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.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Device: IB10 sphingotest® bio-ADM® apparatus (Sphingotec GmbH, Hennigsdorf, Germany)

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.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Poland
  • Warszawa, Poland, 05-002
    • Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	28-day mortality will be assessed	28-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sequential Organ Failure Assessment (SOFA) Score and its changes over time	Occurrence of multiorgan failure expressed in SOFA scores	28-days
Need for catecholamines	Need for catecholamines (drug, highest/lowest dose, duration)	28-days
Need for renal replacement therapy	Need for renal replacement therapy (duration)	28-days
Need for mechanical ventilation	Need for mechanical ventilation (duration)	28-days
Changes of partial pressure of oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) during treatment in ICU	PaO2/FiO2	28-days
Changes in D-dimer	Changes in D-dimer (in ng/ml)	28-days
Changes in blood lactate levels	Changes in blood lactate levels (in mg/dl)	28-days
Changes C reactive protein (CRP)	Changes CRP (in mg/l)	28-days
Changes in procalcitonin levels	Changes in procalcitonin levels (in ng/ml)	28-days
Changes in creatinine levels	Changes in creatinine levels (in mg/dl)	28-days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sepsis complicating the course of COVID-19 during ICU treatment	Occurrence of sepsis complicating the course of COVID-19 during ICU treatment	28-days

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Paweł Zatorski, MD, Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: point of care; sepsis; bio-adrenomedullin
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 042021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No