Clinical trial NCT03025659: Lactate Acidosis in Postoperative Hearts
Official title: Characterization of Lactic Acidosis in Pediatric Postoperative Cardiac Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-cardiac Surgery
Hyperlactatemia
Keywords: pediatric
congenital heart disease
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 43
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric cardiac surgical patients at UF Health Shands Children's Hospital

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lactate/pyruvate ratio
timeFrame: Hourly, assessed up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Shands Children's Hospital
state: Florida
Study officials:
affiliation: University of Florida
name: Michael D Tsifansky, MD
role: PRINCIPAL_INVESTIGATOR
References: