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The CRISIS Prevention Study
This study is currently recruiting participants.
Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), July 2008
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00395161
  Purpose

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.


Condition Intervention Phase
Sepsis
 Drug: Metoclopramide
Drug: Zinc
Dietary Supplement: Glutamine
Drug: Selenium
Other: saline
Other: sterile water
Other: selenium
Dietary Supplement: whey-protein
 Phase III

MedlinePlus related topics: Antibiotics Diets Drinking Water Sepsis
Drug Information available for: Glutamine Metoclopramide hydrochloride Metoclopramide Selenium
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: The Critical Illness Stress-Induced Immune Suppression Prevention Trial

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • The primary endpoint of this study is the time (hours) 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of nosocomial infection or clinical sepsis per 100 PICU days [ Time Frame: 48 hours after PICU admission till discharge from PICU ] [ Designated as safety issue: Yes ]
  • antibiotic-free days [ Time Frame: 48 hours after admission until 5 days after discharged from the PICU ] [ Designated as safety issue: Yes ]
  • incidence of prolonged lymphopenia (absolute lymphocyte count less than or equal to 1,000/mm³ for > or equal to 7 days) [ Time Frame: from time of PICU admission till discharge from PICU ] [ Designated as safety issue: Yes ]
  • all-cause 28-day mortality rate. [ Time Frame: 28 days after admission to the PICU ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: April 2007
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
metoclopramide, zinc, selenium, and glutamine
Drug: Metoclopramide
0.2 mg/kg/dose IV every 12 hours
Drug: Zinc
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)
Dietary Supplement: Glutamine
one enteral dose daily of glutamine 0.3 gm/kg/day
Drug: Selenium
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)
B: Placebo Comparator
saline, sterile water, whey protein
Other: saline
equivalent volume of intravenous saline
Other: sterile water
equivalent volume of sterile water
Other: selenium
equivalent volume of sterile water
Dietary Supplement: whey-protein
one enteral dose daily of whey-protein

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

During the initial accrual period for this study, prior to the first interim analysis, patients will be eligible for enrollment if they:

  • are between 12 months and less than 18 years; AND
  • are within the first 48 hours of the PICU admission; AND
  • have an endotracheal tube, central venous catheter (new or old, tunneled or not tunneled), or Foley catheter; AND
  • are anticipated to have an indwelling arterial or central venous catheter for blood sampling during the first three days of study enrollment.

After the Data Safety Monitoring Board (DSMB) conducts its first interim evaluation, after enrollment of approximately 200 subjects, a decision will be made by the DSMB concerning enrollment of subjects between 40 weeks gestational age and 12 months. If the DSMB approves enrollment of infants after the first interim analysis, then patients will be eligible for enrollment if they:

  • are between 40 weeks gestational age and less than 18 years; AND
  • are within the first 48 hours of the PICU admission; AND
  • have an endotracheal tube, central venous catheter (new or old, tunneled or not tunneled), or Foley catheter; AND
  • are anticipated to have an indwelling arterial or central venous catheter for blood sampling during the first three days of study enrollment.

Exclusion Criteria:

During the initial accrual period for this study, prior to the first interim analysis, patients will be ineligible for enrollment if ANY of the following is true or anticipated:

  • are less than 1 year age; OR
  • are greater than or equal to 18 years of age; OR
  • have a known allergy to metoclopramide; OR
  • planned removal of endotracheal tube, central venous catheter, AND Foley catheters, within 72 hours of study enrollment, OR
  • suspected intestinal obstruction, OR
  • intestinal surgery or bowel disruption, OR
  • chronic metoclopramide therapy prior to enrollment, OR
  • failure to enroll within 48 hours of PICU admission, OR
  • readmission to PICU in the previous 28 days, OR
  • previously enrolled in this study, OR
  • lack of commitment to aggressive intensive care therapies.

After the Data Safety Monitoring Board (DSMB) conducts its first interim evaluation, after enrollment of approximately 200 subjects, a decision will be made by the DSMB concerning enrollment of subjects between 40 weeks gestational age and 12 months. If the DSMB approves enrollment of infants after the first interim analysis, then patients will be ineligible for enrollment if ANY of the following is true or anticipated:

  • are less than 40 weeks gestational age; OR
  • are greater than or equal to 18 years of age; OR
  • have a known allergy to metoclopramide; OR
  • planned removal of endotracheal tube, central venous catheter, AND Foley catheters, within 72 hours of study enrollment, OR
  • suspected intestinal obstruction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00395161

Contacts
Contact: Jeri L Burr, BS, RN-BC, CCRC 801-587-7753 jeri.burr@hsc.utah.edu
Contact: Tracy L Hellem, BSN, RN 801-587-7758 tracy.hellem@hsc.utah.edu

Locations
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
Principal Investigator: Kanwaljeet S Anand, M.D.            
United States, California
Childrens Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Principal Investigator: Christopher Newth, M.D.            
University of California Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90095
Sub-Investigator: Rick Harrison, M.D.            
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Principal Investigator: John Berger, M.D.            
United States, Michigan
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Kathleen Meert, M.D.            
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Joseph Carcillo, M.D.            
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Principal Investigator: Jerry Zimmerman, M.D.            
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Joseph Carcillo, MD University of Pittsburgh
  More Information

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Responsible Party: University of Utah ( J. Michael Dean, MD, MBA )
Study ID Numbers: U01HD049934, CPCCRN-003
Study First Received: October 31, 2006
Last Updated: August 5, 2008
ClinicalTrials.gov Identifier: NCT00395161  
Health Authority: United States: Food and Drug Administration

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
sepsis
prevention
mineral supplementation

Study placed in the following topic categories:
Systemic Inflammatory Response Syndrome
Selenium
Sepsis
Dopamine
Critical Illness
 Zinc
Stress
Metoclopramide
Inflammation

Additional relevant MeSH terms:
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Trace Elements
Dopamine Antagonists
Infection
 Protective Agents
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Micronutrients
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2009



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