Clinical trial: The CRISIS Prevention Study (NCT00395161)

Eligibility 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Months old.
Subject must be at most 17 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Contradiction