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Characterization of Lactic Acidosis in Pediatric Postoperative Cardiac Patients (NCT03025659)

This is a single-center, observational study. Investigators aim to characterize the metabolism of lactate in children over the first forty-eight hours following cardiac surgery. Blood samples will be obtained up to 12 timepoints. Samples will be analyzed for concentration of pyruvate. Results will be compared to standard of care laboratory results for lactate and other direct and indirect measures of cardiac output.
  • Other: Pyruvate levels
    An additional 1 ml of arterial blood will be drawn at each routine postoperative blood draw (Hour 0, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 for participants 10kg and above or only at Hour 0, 2, 4, 6, 8, and 12 for infants under 10 kg) to measure the concentration of pyruvate in blood.
    Ages eligible for Study
    up to 21 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • All immediately post-operative cardiac patients admitted to the pediatric cardiac intensive care unit (PCICU)
    Exclusion Criteria:
    • Lack of parental or patient consent, or patient assent when applicable, including non-English speakers and wards of the state
    • Dosing weight less than 4 kg*
    • Cardiac catheterization being the only operative procedure
    • Severe hepatic dysfunction at any time during the hospital course
    • Seizures during the study period
    • Sepsis during the study period
    • Need for extracorporeal membrane oxygenation or continuous renal replacement therapy
    • Known congenital myopathy, ataxia, polyneuropathies or inborn errors of metabolism including congenital lactic acidosis and other mitochondrial disorders
    • Primary hypoventilation
    • Malignancies
    • Fanconi syndrome
    • Wernicke encephalopathy
    Investigators will characterize the etiologies of hyperlactatemia predominantly present at serial postoperative timepoints in children recovering from cardiac surgery by following lactate levels and the lactate-to-pyruvate ratio over the first 48 post-operative hours and correlating them with cardiac output as determined by conventional markers and physical exam. Investigators expect to validate the assumption that in children recovering from heart surgery whose cardiac output is apparently normal, hyperlactatemia (if seen) is predominantly due to impaired lactate clearance or metabolism, while in those whose cardiac output is low, it is predominantly due to inadequate oxygen delivery. Blood samples will be obtained up to 12 timepoints (arrival at the intensive care unit postoperatively, hour 1, hour 2, hour 3, hour 4, hour 6, hour 8, hour 10, hour 12, hour 24, hour 36 and hour 48 postoperative). Samples will be analyzed for concentration of pyruvate. Results will be compared to standard of care laboratory results for lactate and other direct and indirect measures of cardiac output.

    1 locations

    United States (1)
    • University of Florida Shands Children's Hospital
      recruiting
      Gainesville, Florida, United States, 32610
    Status:
    recruiting
    Type:
    Observational
    Phase:
    -
    Start:
    27 May, 2017
    Updated:
    05 July, 2017
    Participants:
    120
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