Clinical trial NCT03631797: Preoperative Evaluation of Microcirculation for Prediction of Complications After Cardiac Surgery
Official title: L'Etude préopératoire de la Microcirculation Pour la prédiction Des Complications après Une Chirurgie Cardiaque Sous Circulation Extracorporelle.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extracorporeal Circulation; Complications
Keywords: Thoracic Surgery
Microcirculation
Endothelium, vascular
Microvascular reactivity
Laser Speckle
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2018-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative complication
timeFrame: 30 postoperative days
Secondary outcomes:
measure: Evolution of degree of disability
timeFrame: Inclusion and 30 days after surgery
measure: Functional evolution
timeFrame: Inclusion and 30 days after surgery
measure: Mood evolution
timeFrame: Inclusion and 30 days after surgery
measure: Cognitive evolution
timeFrame: Inclusion and 30 days after surgery
Other outcomes:
Locations:
city: Angers
country: France
facility: UH Angers
Study officials:
affiliation: UH Angers
name: Samir HENNI, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.