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NCT Number: NCT03025659

Lactate Acidosis in Postoperative Hearts

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.

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Key information

About this study

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) or only at up to 6 time points (approximately Hour 0, 2, 4, 6, 8, and 12) for infants under 10 kg as described below. . 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pyruvate levels

Other

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.

Primary outcomes

  1. Lactate/pyruvate ratio

    Time frame: Hourly, assessed up to 48 hours

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Characterization of Lactic Acidosis in Pediatric Postoperative Cardiac Patients

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 19, 2017
Registry last updated
Mar 23, 2020

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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