Lactate Acidosis in Postoperative Hearts

Characterization of Lactic Acidosis in Pediatric Postoperative Cardiac Patients

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.

Study Overview

• Status: Completed
• Conditions: Hyperlactatemia; Post-cardiac Surgery
• Intervention / Treatment: Other: Pyruvate levels

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.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida Shands Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric cardiac surgical patients at UF Health Shands Children's Hospital

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pediatric post-cardiac surgery; All immediately post-operative pediatric cardiac patients will be enrolled. Standard of care laboratory analysis will be performed based on current clinical protocols. Results for lactate, blood gases, liver enzymes, creatinine, glucose, hemoglobin, hematocrit and other direct and indirect measure of cardiac output will be collected. Investigators will also measure pyruvate levels at specific time points, which is not part of standard of care. To measure pyruvate, an additional 1 ml of arterial blood will be drawn at each routine postoperative blood draw. The lactate/pyruvate ratio will be calculated and compared to direct and indirect measure of cardiac output described above.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lactate/pyruvate ratio	Hourly, assessed up to 48 hours

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Michael D Tsifansky, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2017
• Primary Completion (Actual): January 24, 2019
• Study Completion (Actual): January 24, 2019

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: pediatric; congenital heart disease
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis; Hyperlactatemia
• Other Study ID Numbers: IRB201601991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be collected on REDCap (secure web application for building and managing online surveys and databases) and available to study staff via password protected access

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No