Methionine Metabolism in Enterally 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 muscle and structural protein synthesis is decreased. The metabolism of sulfur amino acids through the splanchnic area and specifically methionine and cysteine have not been investigated in critically ill septic children, despite that sulfur amino acids have important roles in thiol, antioxidant and epigenetic reactions. Methionine metabolism in sick children will be influenced by its rate of utilization through different pathways. Our study aims to investigate the metabolism of methionine and cysteine when both amino acids are given by the enteral route in critically ill septic children. The investigators are focused on the rates of transmethylation, remethylation and transsulfuration in critically ill septic children, and if the current standard nutrition maintains methionine nutritional balance and functional requirements in critically ill children fed by the enteral route.

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Key information

Conditions

Sepsis Critical Illness Disease Attributes Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms 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 the splanchnic metabolism of methionine to determine the rates of the different pathways and synthesis rates of glutathione when critically ill children are fed by the enteral route, and the difference among various age groups. 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), males 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 15 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Children 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 4.0 kg
Need for enteral nutrition by a nasogastric/nasoduodenal tube
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 unable to tolerate enteral feedings
Weight less than 4.0 kg

Treatment and study plan

Observational

Other

Observational, Translational non-treatment study

Primary outcomes

Methionine Metabolism

Time frame: Clinical Signs, AEs, SAEs, CO2, Tracer Infusion, Blood: (Baseline - 8 hours)

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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Methionine Metabolism in Enterally Fed Critically Ill Children

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Jun 28, 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.

Published trials that share one or more normalized conditions with this study.

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