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Completed

NCT Number: NCT03631797

Preoperative Evaluation of Microcirculation for Prediction of Complications After Cardiac Surgery

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.

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Key information

Conditions

Extracorporeal Circulation; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Angers

Angers, 49933, France

About 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microvascular reactivity evaluation

Procedure

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.

Primary outcomes

  1. 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

  1. Evolution of degree of disability

    Time frame: Inclusion and 30 days after surgery

    Change of modified Rankin scale

  2. Functional evolution

    Time frame: Inclusion and 30 days after surgery

    Change of ADL score

  3. Mood evolution

    Time frame: Inclusion and 30 days after surgery

    Change of brief Geriatric Depression Scale

  4. Cognitive evolution

    Time frame: Inclusion and 30 days after surgery

    Change of Mc Nair test

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: MONS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2018
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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