Status:
TERMINATED
The CRISIS Prevention Study
Lead Sponsor:
Michael Dean
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Seattle Children's Hospital
Conditions:
Sepsis
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
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 childre...
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 childre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT00395161
Start Date
April 1 2007
End Date
November 1 2009
Last Update
April 18 2013
Active Locations (7)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90027
3
University of California Los Angeles Medical Center
Los Angeles, California, United States, 90095
4
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010