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

NCT04813939 | Terminated

• 1 other identifier: 042021
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

bio-adrenomedullin; point of care; sepsis

Outcome Measures

Primary Outcomes (1)

• Mortality

  28-day mortality will be assessed

  28-days

Secondary Outcomes (10)

• Sequential Organ Failure Assessment (SOFA) Score and its changes over time

  28-days

• Need for catecholamines

  28-days

• Need for renal replacement therapy

  28-days

• Need for mechanical ventilation

  28-days

• Changes of partial pressure of oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) during treatment in ICU

  28-days

Other Outcomes (1)

• Sepsis complicating the course of COVID-19 during ICU treatment

  28-days

Interventions

IB10 sphingotest® bio-ADM® apparatus (Sphingotec GmbH, Hennigsdorf, Germany) DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• qualification to palliative care
• life expectancy \< 48 h
• mechanical ventilation at the beginning of the hospitalization
• transfer from other ICU
• pregnancy

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw

Warsaw, 05-002, Poland

Location

MeSH Terms

Conditions

COVID-19; Sepsis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paweł Zatorski, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: March 22, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: May 16, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)