Status:

COMPLETED

Methionine Metabolism in Parenterally Fed Pediatric Sepsis

Lead Sponsor:

The Cleveland Clinic

Conditions:

Sepsis

Critical Illness

Eligibility:

All Genders

1-19 years

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 ...

Detailed Description

This is a prospective, translational study on whole body methionine metabolism and requirements when administered by the parenteral route in critically ill septic children. The study size will include...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

October 1 2012

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 1 2016

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT01891682

Start Date

October 1 2012

End Date

October 1 2016

Last Update

March 22 2017

Active Locations (1)

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Cleveland Clinic

Cleveland, Ohio, United States, 44195