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临床试验/NCT01891682
NCT01891682已完成不适用

Methionine Metabolism in Parenterally Fed Critically Ill Children

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Parenteral Requirements of Methionine

研究概览

简要总结

Critically ill children have abnormal utilization of nutrients such as glucose, lipids and protein. Protein synthesis is increased mainly in the form of immune and signaling proteins, while synthesis of muscle and structural proteins is decreased. The metabolism of sulfur amino acids and specifically methionine and cysteine have not been investigated in critically ill septic children, despite that sulfur amino acids have important roles on thiol, antioxidant and epigenetic reactions, as well as precursor of glutathione (GSH). Methionine metabolism in critically ill children will be influenced by its rate of utilization through the transmethylation, remethylation and transsulfuration pathways, which are the major pathways of methionine metabolism.

The investigators study aims to investigate the metabolism of methionine and cysteine in parenterally fed critically ill septic children. The investigators aim to determine the rates of transmethylation, remethylation, transsulfuration and GSH synthesis rates in critically ill septic children, to determine in vivo, whole body sulfur amino acid metabolism when sulfur amino acids are supplied by the parenteral route. The objective is to determine whether current parenteral intakes support GSH synthesis and if methionine metabolism differs when supplied by the parenteral versus the enteral route. Methionine parenteral requirements will be also studied by using the indicator amino acid oxidation and balance technique.

详细描述

This is a prospective, translational study on whole body methionine metabolism and requirements when administered by the parenteral route in critically ill septic children. The study size will include 45 critically ill septic, pediatric patients (15 infants at 1 month-3 years of age, 15 children at 4-12 years of age and 15 adolescent at 13-19 years of age, male and females admitted to the pediatric intensive care unit (PICU) at Children's Medical Center, Dallas. The minimal subject's weight will be 4 kg. The number of subjects includes an expected drop out rate of about 20%, in order to obtain 12 patients with complete data in each group. Patients will receive nutritional support as per standard care. This study will yield important knowledge and may lead in the future to changes in the current practice on the management of critically ill pediatric patients in the PICU.

Study Aim#1: Determine the parenteral requirements of methionine, in the presence of cysteine, in critically ill septic patients' required extended use of TPN, by using the indicator amino acid oxidation and balance technique.

Study Aim#2: Determine methionine metabolism through the rates of transmethylation, transsulfuration and remethylation at the current standard intakes of methionine of 120 mg.kg.d. with negligible amounts of cysteine.

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
1 Month 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 1 month-19 years
  • Diagnosis of severe sepsis diagnosed as clinical sepsis syndrome (requires two of the following criteria):
  • Source of infection
  • Fever or Hypothermia
  • Leukocytosis or Leucopenia
  • Poor organ perfusion (such as delayed capillary refill or decreased urine output or hypotension)
  • Bacteremic sepsis demonstrated by positive blood culture
  • Weight greater or equal to 4 kg
  • Need for parenteral nutrition
  • Presence of central and/or arterial venous access as per clinical indication

排除标准

  • Patients with metabolic diseases (i.e. Insulin dependent diabetes mellitus, urea cycle disorders, cystinuria, etc.)
  • Primary liver failure
  • Primary renal failure
  • Patients on enteral feedings greater than 20% of daily requirement
  • Weight less than 4.0 kg

结局指标

主要结局

Parenteral Requirements of Methionine

时间窗: 8 hours

Breakpoint between the rates of indicator amino acid oxidation and level of parenteral methionine intake.

次要结局

  • Methionine Metabolism(8 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leticia Castillo

Department Chair Peds Critical Care

The Cleveland Clinic

研究点 (1)

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