Cardiosurgery Clinical Trial
Official title:
Continuous Monitoring of Lactate in High-risk Cardiac Surgery
The major combined interventions are between challenging and high-risk aspects of current
cardiosurgical practice. The results of operation may be hampered by unexpected anatomic and
technical features influencing the surgical approach as well as cardiopulmonary bypass
(CPB), anesthesia, and respiratory support.
Plasma lactate concentration is a routine clinical indicator of the tissue oxygen shortage,
and is routinely monitored in virtually all in-risk surgical and ICU patients. However, the
discrete measurement of these values among with other biochemical values has a major
drawback and continuous measurement can be beneficial.
The aim of our study is to assess the clinical usefulness and rationale for routine use of
continuous monitoring of lactate in high-risk combined/complex cardiac surgery.
The combination of coronary artery bypass grafting (CABG), repair of valve pathology and/or
valve replacement remains a challenging and high-risk aspect of current cardiosurgical
practice. Direct and indirect results of surgery are affected by the variety of factors
including patient's age, general condition, preoperative severity of heart dysfunction and
remodeling, etc. In addition, the results of operation may be hampered by unexpected
anatomic and technical features influencing the surgical approach as well as duration of
cardiopulmonary bypass (CPB) and aortic cross clamping, anesthesia, intensive care and
respiratory support.
The combined and complex cardiac surgery requires CPB, which, in parallel with increased
duration of intervention, induces systemic inflammatory response and ischemia-reperfusion
injury. These pathophysiological mechanisms include activation of cytokines, complement,
neutrophils, monocytes, endothelium and platelets. Neutrophil sequestration in the vital
organs in response to chemotaxis and release of reactive oxygen species and inflammatory
mediators may result in tissue hypoperfusion and multiple organ dysfunction syndrome,
contributing to development of postoperative complications and adverse outcomes.
To alleviate CPB-induced systemic inflammatory response and organ-specific injury, different
interventions exist, including meticulous hemodynamic and metabolic monitoring followed by
goal-directed therapy. Several recent studies from our group and other authors have clearly
demonstrated the beneficial effects of such an approach in cardiac surgery. In these
settings, when the extraction of O2 on cellular level may be severely disturbed, the complex
analysis of changes in tissue perfusion and oxygenation before adjusting the therapy may be
useful.
Current technique of continuous monitoring of lactate using Eirus system has a potential to
broaden our knowledge in this clinical scenario and reinforce a decision-making in high-risk
cardiac surgery. Hence, continuous measurement of lactate may be a valuable adjunct to
routine hemodynamic parameters and blood gases, facilitating changes in fluid therapy and
inotrope/vasopressor support for the achievement an adequate balance between oxygen demand
and delivery. Combination of continuously measured lactate with monitoring of cardiac
output, mixed and central venous saturation and Pv-aCO2 seems to be an attractive approach
to "global view" on the systemic oxygen transport at the bedside. Recently, the continuous
monitoring of lactate has been validated in a pilot clinical study in cardiosurgical
patients mostly with isolated CABG and aortic valve replacement with relatively short-term
CPB, however its' role in combined cardiac surgery with prolonged CPB, representing the
important setting for lactate-guided therapy, remains unsettled.
Thus, the aim of our study is to assess the use of continuous monitoring of lactate in
high-risk combined/complex cardiac surgery.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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