MONS: Preoperative Evaluation of Microcirculation for Prediction of Complications After Cardiac Surgery

Sponsor

University Hospital, Angers (Other)

Overall Status

Completed

CT.gov ID

NCT03631797

Collaborator

(none)

Enrollment

Location

Arm

13.9

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Extracorporeal Circulation; Complications	Procedure: Microvascular reactivity evaluation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 14, 2019

Actual Primary Completion Date :

Jan 13, 2020

Actual Study Completion Date :

Mar 13, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Postoperative complication [30 postoperative days]
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%).

Secondary Outcome Measures

Evolution of degree of disability [Inclusion and 30 days after surgery]
Change of modified Rankin scale
Functional evolution [Inclusion and 30 days after surgery]
Change of ADL score
Mood evolution [Inclusion and 30 days after surgery]
Change of brief Geriatric Depression Scale
Cognitive evolution [Inclusion and 30 days after surgery]
Change of Mc Nair test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UH Angers	Angers		France	49933

Sponsors and Collaborators

University Hospital, Angers

Investigators

Principal Investigator: Samir HENNI, MD PhD, UH Angers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT03631797

Other Study ID Numbers:

2018-A2341-54

First Posted:

Aug 15, 2018

Last Update Posted:

Jun 3, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Angers

Thoracic Surgery

Microcirculation

Endothelium, vascular

Microvascular reactivity

Laser Speckle

Study Results

No Results Posted as of Jun 3, 2021