NCT03025659

Lactate Acidosis in Postoperative Hearts

Characterization of Lactic Acidosis in Pediatric Postoperative Cardiac Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-cardiac Surgery
• Hyperlactatemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-05-28
• Primary completion: 2019-01-24
• Completion: 2019-01-24
• First posted: 2017-01-19
• Last updated: 2020-03-23

Locations

1 site across 1 country: United States