An interventional study of Microvascular reactivity evaluation in Extracorporeal Circulation; Complications, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-10.
Sponsored by University Hospital, Angers · Not applicable, Interventional, and Diagnostic
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.
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.
University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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%).
Time frame: 30 postoperative days
Evolution of degree of disability
Change of modified Rankin scale
Time frame: Inclusion and 30 days after surgery
Functional evolution
Change of ADL score
Time frame: Inclusion and 30 days after surgery
Mood evolution
Change of brief Geriatric Depression Scale
Time frame: Inclusion and 30 days after surgery
Cognitive evolution
Change of Mc Nair test
Time frame: Inclusion and 30 days after surgery
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Angers