Methionine Metabolism in Enterally Fed Pediatric Sepsis

NCT01889264 | Completed DMC

• 1 other identifier: STU-042011-088
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Critical Illness

Keywords

Methionine Metabolism; Enteral Nutrition; Pediatric; Pediatrics; Sepsis; Observational Study

Outcome Measures

Primary Outcomes (1)

• Methionine Metabolism

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

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

Study Arms (1)

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

Interventions

Observational OTHER

Observational, Translational non-treatment study

Critically Ill Pediatric Patients

Eligibility Criteria

• Age: 1 Month - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples.

MeSH Terms

Conditions

Sepsis; Critical Illness

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Leticia Castillo, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chair Peds Critical Care

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: June 28, 2013
• Study Start: December 1, 2011
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

US (1)