Lactate Acidosis in Postoperative Hearts

NCT ID: NCT03025659

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-28
• Study Completion Date: 2019-01-24

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.

Conditions

Post-cardiac Surgery; Hyperlactatemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Pyruvate levels

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael D Tsifansky, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida Shands Children's Hospital

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201601991

Identifier Type: -

Identifier Source: org_study_id