Preoperative Evaluation of Microcirculation for Prediction of Complications After Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-14

Study Completion Date

2019-04-26

Brief Summary

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Cardiac surgery is responsible for many complications. Microcirculation is involved in many of them. The objective of this study is to prospectively investigate the prognostic value of preoperative microcirculatory assessment in patients scheduled for cardiac surgery with CPB for the occurrence of postoperative complications.

Microvascular dysfunction is suspected of being involved in postoperative psycho-cognitive decline. The influence of microcirculation on the evolution of psycho-cognitive assessment is also analyzed in this study.

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Detailed Description

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Eligible patients are included during the preoperative assessment. Written consent is signed after complete explanation of the protocol.

Patient characteristics as treatments, medical history, and EuroSCORE II are registered. Moreover, intraoperative data is collected. Psycho-cognitive and functional evaluation is made preoperatively.

Microcirculation is evaluated for each patient before surgery. Complications are registered at the end of hospital stay. Psycho-cognitive and functional evaluation is repeated by call 30 days after the surgery.

Conditions

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Extracorporeal Circulation; Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Microvascular reactivity evaluation

Patients referred for a preoperative arterial palmar arches assessment before cardiac valvular or coronary surgery.

Intervention is measurement of microvascular reactivity with a laser speckle contrast imaging before surgery.

Group Type EXPERIMENTAL

Microvascular reactivity evaluation

Intervention Type PROCEDURE

Microcirculation will be evaluated for each patient before surgery with a laser speckle contrast imaging (LSCI) placed on the forearm. Tests will be performed for evaluation of endothelium reactivity: Iontophoresis.

Interventions

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Microvascular reactivity evaluation

Microcirculation will be evaluated for each patient before surgery with a laser speckle contrast imaging (LSCI) placed on the forearm. Tests will be performed for evaluation of endothelium reactivity: Iontophoresis.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Valvular ou coronary elective cardiac surgery under cardiopulmonary bypass
* Fair skin phototype
* Ability to understand the study goal, no dementia.
* Affiliation to the French National Healthcare System
* Voluntary patients who have signed an informed consent

Exclusion Criteria

* Emergency surgery
* Multiple procedures, combined surgery (valvular and coronary)
* Single aortic surgery
* Patient already included in the study (second surgery)
* Patients protected by decision of law

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No