L'Etude préopératoire de la Microcirculation Pour la prédiction Des Complications après Une Chirurgie Cardiaque Sous Circulation Extracorporelle.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Postoperative complication
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Postoperative complication
Time Frame: 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 Outcomes
- Cognitive evolution(Inclusion and 30 days after surgery)
- Functional evolution(Inclusion and 30 days after surgery)
- Mood evolution(Inclusion and 30 days after surgery)
- Evolution of degree of disability(Inclusion and 30 days after surgery)