Lactate Acidosis in Postoperative Hearts

NCT03025659 | Completed

• 1 other identifier: IRB201601991
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-cardiac Surgery; Hyperlactatemia

Keywords

pediatric; congenital heart disease

Outcome Measures

Primary Outcomes (1)

• Lactate/pyruvate ratio

  Hourly, assessed up to 48 hours

Study Arms (1)

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

Interventions

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.

Pediatric post-cardiac surgery

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All immediately post-operative cardiac patients admitted to the pediatric cardiac intensive care unit (PCICU)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Shands Children's Hospital

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Hyperlactatemia; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michael D Tsifansky, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 19, 2017
• Study Start: May 28, 2017
• Primary Completion: January 24, 2019
• Study Completion: January 24, 2019
• Last Updated: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)