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

• Sponsor: Medical University of Warsaw (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04813939
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Actual Duration (Months): 10.3
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	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 Design

• Study Type: Observational
• Actual Enrollment: 32 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Is Bio-adrenomedullin (Bio-ADM) a Prognostic Factor in Patients With COVID-19 Treated in the ICU?
• Actual Study Start Date: Mar 22, 2021
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Jan 31, 2022

Outcome Measures

Primary Outcome Measures

1. Mortality [28-days]

   28-day mortality will be assessed

Secondary Outcome Measures

1. Sequential Organ Failure Assessment (SOFA) Score and its changes over time [28-days]

   Occurrence of multiorgan failure expressed in SOFA scores

2. Need for catecholamines [28-days]

   Need for catecholamines (drug, highest/lowest dose, duration)

3. Need for renal replacement therapy [28-days]

   Need for renal replacement therapy (duration)

4. Need for mechanical ventilation [28-days]

   Need for mechanical ventilation (duration)

5. Changes of partial pressure of oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) during treatment in ICU [28-days]

   PaO2/FiO2

6. Changes in D-dimer [28-days]

   Changes in D-dimer (in ng/ml)

7. Changes in blood lactate levels [28-days]

   Changes in blood lactate levels (in mg/dl)

8. Changes C reactive protein (CRP) [28-days]

   Changes CRP (in mg/l)

9. Changes in procalcitonin levels [28-days]

   Changes in procalcitonin levels (in ng/ml)

10. Changes in creatinine levels [28-days]

    Changes in creatinine levels (in mg/dl)

Other Outcome Measures

1. Sepsis complicating the course of COVID-19 during ICU treatment [28-days]

   Occurrence of sepsis complicating the course of COVID-19 during ICU treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Warsaw	Warszawa		Poland	05-002

Sponsors and Collaborators

• Medical University of Warsaw

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Warsaw
• ClinicalTrials.gov Identifier: NCT04813939
• Other Study ID Numbers: 042021
• First Posted: Mar 24, 2021
• Last Update Posted: May 16, 2022
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Medical University of Warsaw: bio-adrenomedullin; point of care; sepsis
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of May 16, 2022