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临床试验/NCT03025659
NCT03025659已完成不适用

Characterization of Lactic Acidosis in Pediatric Postoperative Cardiac Patients

University of Florida1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2017年5月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Lactate/pyruvate ratio

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Lactate/pyruvate ratio

时间窗: Hourly, assessed up to 48 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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