Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
NCT ID:
NCT00573066
Eligibility Criteria:
Inclusion Criteria:
* Patients must be greater or equal to one month or less than or equal to 24 months of age.
* Post operative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period.
* Planned tracheal extubation within 24 hours post-operatively.
* Adequate renal function(1-12 months old creatinine less than or equal to 0.6mg/dL and \>12 months to 24 months creatinine \< or= to 1.0mg/dL)
* Adequate liver function(Total bilirubin \< or= 1.5mg/dL and ALT 1-12 months \< or = to 165 U/L and \> 12 months to 24 months \< or = to 90 U/L)
* Isolated heart surgery
* Informed consent
Exclusion Criteria:
* Patients who have received another investigational drug within the past 30 days.
* Receiving continuous infusions of muscle relaxants in the postoperative setting.
* Patients whoo have a positive blood culture without a subsequent negative culture or other evidence of ongoing serious infection.
* Patients, who, int he opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
* Patients who show signs or symptoms of elevated intracranial pressure.
* Post-operative hypotension based on age.
* Preexisting bradycardia based on age.
* Heart block
* Weight \< 5kg
* Patients, who in the opinion of the investigator, are not appropriate candidates for an investigational drug study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
24 Months
Study:
NCT00573066
Study Brief:
Protocol Section:
NCT00573066