Proadrenomedullin and Microcirculation in Monitoring Organ Dysfunction in Patient With Infection

NCT03931967 | Completed

• 1 other identifier: MicroMRproADM
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the association between plasmatic levels of Mid Regional Proadrenomedullin (MR-proADM) and the sublingual microcirculation in critical care patients admitted with infection, sepsis or septic shock.

Conditions

Infection; Sepsis; Septic Shock

Keywords

Sepsis; Septic shock; Microcirculation; Glycocalix; Proadrenomedullin; Organ dysfunction; Critical Care; Intensive Care

Outcome Measures

Primary Outcomes (2)

• Assessment of Microvascular Flow Index (MFI)

  Correlation between plasmatic value of MR-proADM and variation in Microvascular Flow Index (MFI) in patients admitted in ICU with suspected infection. MFI is detected in vivo by Incident Dark Field (IDF) Imaging at sublingual microcirculation. It represents the quality of blood flow at microcirculatory level.

  Five days

• Assessment of the concentration of Mid Regional Proadrenomedullin (MR-proADM)

  Correlation between plasmatic value of MR-proADM and variation in Microvascular Flow Index (MFI) in patients admitted in ICU with suspected infection. Mid Regional Proadrenomedullin (MR-proADM, unity of measurement nmol/L) is measured through a specify immunoenzymatic assay. MR-proADM is a diagnostic and prognostic marker of infection and sepsis.

  Five days

Secondary Outcomes (7)

• Cut-off for Microvascular Flow Index (MFI) based on Mid Regional Proadrenomedullin (MR-proADM) levels

  Five days

• Assessment of patient's mortality

  Five days

• Assessment of new organ failure

  Five days

• Assessment of Procalcitonine (PCT)

  Five days

• Assessment of other microcirculatory parameters in patient with sepsis or septic shock.

  Five days

Study Arms (1)

MR-proADM

Diagnostic Test: MR-proADM

Interventions

MR-proADM DIAGNOSTIC_TEST

to evaluate the plasmatic level of MR-proADM and endothelin-1 in the first five days of ICU stay.

MR-proADM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

20 patients with suspected infection, infection, sepsis or septic shock admitted to ICU

You may qualify if:

• Suspected Infection, Infection, Sepsis or Septic Shock in patient admitted in ICU from no more than 24 hours and which have previously monitored blood pressure and have a central venous catheter in place.

You may not qualify if:

• Age \< 18 yo
• Length of stay in ICU \> 24 hours;
• Length of stay in other hospital unit, ward or surgery \> 48 hours;
• Refusal of informed consent;
• Conditions that do not allow the possibility of getting a monitoring of sublingual microcirculation (maxillofacial trauma, serious inability to jaw, copious blood loss or secretions from the mouth)

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

AOU Ospedali Riuniti Ancona - Università Politecnica delle Marche

Ancona, 60126, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dosage of MicroMRproADM, endothelin-1

MeSH Terms

Conditions

Infections; Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Abele Donati, MD, PhD

  UNIVERSITA' POLITECNICA DELLE MARCHE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: April 30, 2019
• Study Start: November 8, 2018
• Primary Completion: June 4, 2019
• Study Completion: June 4, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-04

Locations

IT (1)