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Methionine Metabolism in Enterally Fed Pediatric Sepsis

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ClinicalTrials.gov Identifier: NCT01889264
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Leticia Castillo, The Cleveland Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment
Sepsis Critical Illness Other: Observational

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Methionine Metabolism in Enterally Fed Critically Ill Children
Study Start Date : December 2011
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
Drug Information available for: Methionine

Group/Cohort Intervention/treatment
Critically Ill Pediatric Patients
Critically ill septic pediatric patients, Age 1 month-3 years, Age 4-12 years and Age 13-19 years, males and females
Other: Observational
Observational, Translational non-treatment study




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Blood samples.


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Ages Eligible for Study:   1 Month to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Septic pediatric patients: A total of 45 critically ill children age 1 month-19 years with diagnosis of sepsis, as defined by the International Sepsis Consensus Conference.
Criteria

Inclusion Criteria:

  1. Children age 1 month-19 years
  2. 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
  3. Weight greater or equal to 4.0 kg
  4. Need for enteral nutrition by a nasogastric/nasoduodenal tube
  5. Presence of central and/or arterial venous access as per clinical indication

Exclusion Criteria:

  1. Patients with metabolic diseases (i.e. Insulin dependent diabetes mellitus, urea cycle disorders, cystinuria, etc.)
  2. Pregnancy
  3. Primary liver failure
  4. Primary renal failure
  5. Patients unable to tolerate enteral feedings
  6. Weight less than 4.0 kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889264


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Leticia Castillo, M.D. The Cleveland Clinic

Responsible Party: Leticia Castillo, Department Chair Peds Critical Care, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01889264     History of Changes
Other Study ID Numbers: STU-042011-088
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017

Keywords provided by Leticia Castillo, The Cleveland Clinic:
Methionine Metabolism
Enteral Nutrition
Pediatric
Pediatrics
Sepsis
Observational Study

Additional relevant MeSH terms:
Sepsis
Critical Illness
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes