Methionine Metabolism in Parenterally Fed Pediatric Sepsis

NCT01891682 | Completed DMC

• 1 other identifier: STU-022012-035
• 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 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.

Conditions

Sepsis; Critical Illness

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Parenteral Requirements of Methionine

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

  8 hours

Secondary Outcomes (1)

• Methionine Metabolism

  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:

• 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

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 on enteral feedings greater than 20% of daily requirement
• 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; Hyperphagia

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

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

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: June 24, 2013
• First Posted: July 3, 2013
• Study Start: October 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

US (1)