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Completed

NCT Number: NCT01891682

Methionine Metabolism in Parenterally Fed Pediatric Sepsis

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.

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Key information

Conditions

Sepsis Critical Illness Disease Attributes Hyperphagia Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Systemic Inflammatory Response Syndrome

Age range

1 month–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Observational

Other

Observational, Translational non-treatment study

Primary outcomes

  1. Parenteral Requirements of Methionine

    Time frame: 8 hours

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

Secondary outcomes

  1. Methionine Metabolism

    Time frame: 8 hours

    Rates of transmethylation, remethylation and transsulfuration and erythrocyte GSH synthesis when nutrients are given by the parenteral route in pediatric critically ill patients.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Methionine Metabolism in Parenterally Fed Critically Ill Children

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 3, 2013
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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