The CRISIS Prevention Study

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Dean
• Collaborators: Arkansas Children's Hospital Research Institute; Children's Hospital Los Angeles; Children's Hospital of Michigan; Children's National Research Institute; Children's Research Institute; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Harborview Injury Prevention and Research Center; Seattle Children's Hospital; University of California, Los Angeles; University of Pittsburgh
• Treatments: Metoclopramide; Selenium; Zinc

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