Preoperative Evaluation of Microcirculation for Prediction of Complications After Cardiac Surgery (MONS)

L'Etude préopératoire de la Microcirculation Pour la prédiction Des Complications après Une Chirurgie Cardiaque Sous Circulation Extracorporelle.

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.

Study Overview

• Status: Completed
• Conditions: Extracorporeal Circulation; Complications
• Intervention / Treatment: Procedure: Microvascular reactivity evaluation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • UH Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complication	Composite criteria and include microcirculation postoperative complications: Late surgical re-intervention (greater than 12 hours) for evacuation of pericardial effusion (seeps),; Surgical wound disunion or surgical site infection,; Organ failure: SOFA score greater than 2 at 48h,; Postoperative confusion: assessed using the Confusion Assessment Method (CAM) or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU),; Acute renal failure ≥ stage 2 according to the KDIGO classification,; Acute lung injury defined as PaO2 <55mmHg in ambient air, PaO2 / FiO2 ratio <250 or Pulse Oxygen Saturation (SpO2) <90% and need for oxygen therapy,; Atrial fibrillation (excluding patients with permanent Atrial Fibrillation preoperatively),; Hepatocellular injury (Cytolysis > 10N, Prothrombin rate and Factor V decreased < 60%).	30 postoperative days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of degree of disability	Change of modified Rankin scale	Inclusion and 30 days after surgery
Functional evolution	Change of ADL score	Inclusion and 30 days after surgery
Mood evolution	Change of brief Geriatric Depression Scale	Inclusion and 30 days after surgery
Cognitive evolution	Change of Mc Nair test	Inclusion and 30 days after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Publications and helpful links

General Publications

• Abrard S, Fouquet O, Riou J, Rineau E, Abraham P, Sargentini C, Bigou Y, Baufreton C, Lasocki S, Henni S. Preoperative endothelial dysfunction in cutaneous microcirculation is associated with postoperative organ injury after cardiac surgery using extracorporeal circulation: a prospective cohort study. Ann Intensive Care. 2021 Jan 7;11(1):4. doi: 10.1186/s13613-020-00789-y.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2019
• Primary Completion (ACTUAL): April 26, 2019
• Study Completion (ACTUAL): April 26, 2019

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (ACTUAL): August 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Thoracic Surgery; Microcirculation; Endothelium, vascular; Microvascular reactivity; Laser Speckle
• Other Study ID Numbers: 2018-A2341-54

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No