CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
NIRS monitoring +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04058860
NCT04058860N/ACompleted
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Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery; Challenging Near-infrared Spectroscopy With Microvascular Density and Metabolic Parameters

AHEPA University Hospital·interventional·Posted Aug 16, 2019·Updated Jul 25, 2022

In Brief

A clinical study evaluating NIRS monitoring, Cox monitoring, and 1 other intervention for Heart Diseases. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery under extracorporeal circulation. Positive clinical results evidenced with goal-directed perfusion and cerebral oximetry monitoring could be attributed to preserved microcirculation at tissue level.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Diseases
CountriesGreece
CollaboratorsMedtronic - MITG

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 16, 2019
Enrollment StartJun 1, 2020
Primary CompletionNov 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.9 years ago

Interventions

NIRS monitoringdevice

Cerebral and somatic near-infrared spectroscopy (rScO2) measurements

Cox monitoringdevice

Cerebral autoregulation monitoring

Sublingual microscopydevice

Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging