Sublingual Microcirculation Monitoring in ICU

NCT02649088 | Completed

• 1 other identifier: 212639
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective observational study designed to implement a daily monitoring of microcirculation and tissue oxygenation in all critically ill patients admitted to the ICU in the period of nine months, in order to assess the prevalence of microvascular perfusion abnormalities and their relation to: outcomes, underlying disease, hospital stay, clinical-laboratory and hemodynamic parameters commonly measured, indices of clinical severity and predictors of mortality , therapeutic interventions that are part of routine clinical practice (fluids, sedation, vasopressors, inotropes, anticoagulants, renal replacement therapy, blood transfusion). The study also includes the evaluation of sublingual microcirculation and tissue oxygenation in 30 healthy volunteers to compare normal and pathological conditions. Within the first 12 hours after admission to ICU and every 24 hours for the duration of hospitalization, the following evaluations will be made: -study of sublingual microcirculation using sidestream dark field (SDF) imaging, muscle tissue oxygenation using near infrared spectroscopy (NIRS). The data will be analyzed to test correlation between the outcome of patients admitted in ICU and microcirculatory parameters.

Conditions

Critical Illness

Keywords

microcirculation; tissue oxygenation; outcome

Outcome Measures

Primary Outcomes (2)

• Correlation between changes in perfused vessel density and 90 days mortality from ICU admission

  The perfused vessel density (PVD) is defined as the quantity (mm/mmq) of microcirculatory vessels which have a good flow and it is calculated using a dedicated software described elsewhere.

  90 days

• Correlation between changes in StO2 upload and 90 days mortality from ICU admission

  During vascular occlusion test, the changes of StO2 and StO2 values can divided into 3 epoch; Desaturation (StO2 download), Reoxygenation (StO2 upload), and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation are calculated.

  90 days

Secondary Outcomes (6)

• Correlation between Perfused vessel density and central venous saturation

  Study frame: nine months

• Correlation between Perfused vessel density and blood lactate

  Study frame: nine months

• Correlation between Perfused vessel density and ICU length of stay

  Study frame: nine months

• Correlation between Perfused vessel density and hospital length of stay

  Study frame: nine months

• Correlation between Perfused vessel density and SOFA score

  Study frame: nine months

Interventions

Microscan DEVICE

It allows to look at sublingual microcirculation

NIRS from Hutchinson DEVICE

It allows to monitor tissue oxygen saturation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted in intensive care unit

You may qualify if:

• adult patients admitted in ICU

You may not qualify if:

• age \<18
• expected ICU length of stay \<24 hrs
• any conditions that preclude sublingual microcirculatory evaluation (e.g. facial trauma)
• readmitted patients previously enrolled in the present study

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

University ICU, AOU Ospedali Riuniti Ancona

Torrette Di Ancona, Ancona, 60126, Italy

Location

Related Publications (2)

• Scorcella C, Damiani E, Domizi R, Pierantozzi S, Tondi S, Carsetti A, Ciucani S, Monaldi V, Rogani M, Marini B, Adrario E, Romano R, Ince C, Boerma EC, Donati A. MicroDAIMON study: Microcirculatory DAIly MONitoring in critically ill patients: a prospective observational study. Ann Intensive Care. 2018 May 15;8(1):64. doi: 10.1186/s13613-018-0411-9.

  PMID: 29766322 DERIVED

• Donati A, Damiani E, Domizi R, Scorcella C, Carsetti A, Tondi S, Monaldi V, Adrario E, Romano R, Pelaia P, Singer M. Near-infrared spectroscopy for assessing tissue oxygenation and microvascular reactivity in critically ill patients: a prospective observational study. Crit Care. 2016 Oct 1;20(1):311. doi: 10.1186/s13054-016-1500-5.

  PMID: 27716370 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abele Donati, MD

  Università 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: Associate Professor

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: January 7, 2016
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2014
• Last Updated: January 7, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)