Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial infection and sepsis remain the leading acquired causes of morbidity and mortality in critically ill children. Subsequent use of antibiotics to treat nosocomial infection and sepsis is considered a major attributable factor in the rise of antibiotic-resistant organisms in this population of children. This study will use a double-blind, randomized, controlled trial design to test the hypothesis that daily prophylaxis with metoclopramide, zinc, selenium and glutamine will reduce nosocomial infection and sepsis in critically ill children.
Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial infection and sepsis remain the leading acquired causes of morbidity and mortality in critically ill children. Subsequent use of antibiotics to treat nosocomial infection and sepsis is considered a major attributable factor in the rise of antibiotic-resistant organisms in this population of children. Presently, "prophylaxis" strategies are used to prevent stress-induced gastrointestinal bleeding; however, no "prophylaxis" strategy is used to prevent stress-induced nosocomial infection and sepsis. When left unopposed, the stress hormone, cortisol, induces lymphocyte apoptosis, lymphopenia, and immune insufficiency. Prolactin is the counter-regulatory stress hormone that prevents cortisol-induced apoptosis and immunosuppression. Zinc, selenium, and glutamine are also important in maintenance of lymphocyte health. Critically ill patients commonly develop hypoprolactinemia secondary to increased central nervous system dopaminergic activity, as well as zinc, selenium, and glutamine deficiency caused by increased utilization and decreased supply. Hypoprolactinemia can be prevented by metoclopramide, a dopamine 2 receptor antagonist commonly used as a prokinetic in children, and zinc, selenium, and glutamine deficiency can be prevented with enteral supplementation. This study will use a double-blind randomized controlled trial design to test the hypothesis that daily prophylaxis with metoclopramide, zinc, selenium and glutamine will reduce nosocomial infection and sepsis in critically ill children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
293
0.2 mg/kg/dose IV every 12 hours
one enteral dose daily of zinc chloride (10 mg/day elemental zinc for infants \< or equal to one year of age, and 20 mg/day elemental zinc for patients \> 1 year of age)
one enteral dose daily of glutamine 0.3 gm/kg/day
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Childrens Hospital of Los Angeles
Los Angeles, California, United States
University of California Los Angeles Medical Center
Los Angeles, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
The Primary Endpoint of This Study is the Median Time Between Admission to the PICU and Occurrence of Nosocomial Infection or Clinical Sepsis in PICU Patients Who Have Endotracheal Tubes, Central Venous Catheters, or Urinary Catheters.
Time frame: 48 hours after admission until 5 days after discharged from the PICU
Rate of Nosocomial Infection or Clinical Sepsis Per 100 Study Days
Time frame: 48 hours after PICU admission till discharge from PICU
Antibiotic-free Days
Time frame: 48 hours after admission until PICU discharge
Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days)
What is reported is the number of participants with counts qualifying as lymphopenia.
Time frame: from time of PICU admission till discharge from PICU
All-cause 28-day Mortality Rate.
Time frame: 28 days after admission to the PICU
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one enteral dose daily of selenium (40 μg for infants \< 8 months of age, 60 μg for infants 8 to 12 months of age, 90 μg for children 1-3 years, 150 μg for children 4-8 years, 280 μg for children 9 to 13 years, and 400 μg for children \> 13 years)
equivalent volume of intravenous saline
equivalent volume of sterile water
equivalent volume of sterile water
one enteral dose daily of whey-protein
Children's Hospital of Michigan
Detroit, Michigan, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Seattle Children's Hospital
Seattle, Washington, United States