Gluconeogenesis Rates and Its Precursors in Pediatric Sepsis

NCT01890928 | Completed DMC

• 1 other identifier: STU-072010-051
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Critically ill children have abnormal utilization of nutrients such as glucose, lipids and protein. Often sick children have increased glucose concentrations in blood. However, the origin of the high glucose has not been determined in these populations. There is a close interrelationship between protein and energy metabolism. An increase in the energy supply will not promote nitrogen retention unless the amino acid supply is adequate, and conversely, an increased amino acid supply will be useless if energy is limiting, hence the importance of adequate protein and energy intake. Our study aims to investigate the protein-energy interactions in critically ill septic children and adolescents with the objective to eventually provide the best nutritional support for these patients.

Conditions

Sepsis; Hyperglycemia; Critical Illness

Keywords

Gluconeogenesis; Glycogenolysis; Pyruvate cycling; Glucose production rates; Mitochondria; Acylcarnitines

Outcome Measures

Primary Outcomes (1)

• Gluconeogenesis Rates

  Rates of gluconeogenesis from glycerol, lactate/amino acids in relation to protein synthesis, breakdown and balance, and pyruvate cycling among different age groups (children vs. adolescents) and in comparison with healthy adolescents.

  24 hours

Secondary Outcomes (1)

• Metabolic Source for Gluconeogenesis

  24 hours during study and overall ICU admission

Other Outcomes (1)

• Length of ICU stay

  24 hours

Study Arms (2)

Critically Ill Septic Pediatric Patients

Age 5-12 years; weight ≥ 17kg and Age 13-19 years, males and females

Healthy Adolescents

Age 13-19 years, males and females

Eligibility Criteria

• Age: 5 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Septic pediatric subjects: A total of 45 critically ill children age 5-19 years with diagnosis of sepsis, as defined by the International Sepsis Consensus Conference. Healthy subjects: A total of 30 healthy adolescents 13-19 years matched for age, gender, Tanner and BMI to serve as controls. A Dexa scan will be obtained to determine lean body mass.

You may qualify if:

• Children age 5-19 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
• Indwelling central and/or arterial venous access as per clinical indication.

You may not qualify if:

• Patients with metabolic diseases (i.e.: urea cycle disorders, cystinuria, Insulin dependent diabetes mellitus, etc.).
• Pregnancy.
• Primary liver failure.
• Healthy Children:
• Age 13-19 years.
• Evidence of health as assessed by physical exam, and laboratory tests, including: Hematocrit no less than 36% for males and no less than 37% for females, white blood cell count from 5-10,000.
• Chemistries within normal range, normal urine analysis, and fasting plasma glucose level no less than 60 or greater than 104 mg/dL.
• Lean Children with BMI of 18-24.
• Obese Children with BMI of 30 or greater.
• Tobacco use.
• Pregnancy.
• Taking any prescription medication that affects amino acid metabolism, i.e., glucocorticoids.
• History of acute or chronic illness.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• University of Texas: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Biospecimen

Retention: NONE RETAINED

Blood and urine samples.

MeSH Terms

Conditions

Sepsis; Hyperglycemia; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes

Study Officials

• Leticia Castillo, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thomas Fariss Marsh Jr Professor in Pediatrics

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 2, 2013
• Study Start: March 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 28, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)