Lactate Acidosis in Postoperative Hearts

Post-cardiac Surgery Clinical Trial

Official title:

Characterization of Lactic Acidosis in Pediatric Postoperative Cardiac Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025659
• Other study ID #: IRB201601991
• Status: Completed
• Start date: May 28, 2017
• Est. completion date: January 24, 2019

Study information

• Verified date: March 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 24, 2019
• Est. primary completion date: January 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Hyperlactatemia
• Post-cardiac Surgery

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida Shands Children's Hospital	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lactate/pyruvate ratio		Hourly, assessed up to 48 hours