The CRISIS Prevention Study

Stopped early · Phase 3

Conditions studied: Sepsis

In brief

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.

Key facts

Study ID

NCT00395161

Run by

Michael Dean

People needed

293

Starts

2007-04-01

Expected to finish

2009-11-01

Last updated by the study team

2013-04-18

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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