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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT01531803
Eligibility Criteria:
Inclusion Criteria:
1. Male or female aged 0 days to 12 years, inclusive:
* (0 to 28 days);
* (29 days to 23 months);
* (2 to 5 years 11 months);
* (6 to 12 years).
2. Subjects undergoing elective cardiac, abdominal, orthopedic, or transplant surgery.
3. Subjects with a clinical diagnosis of hypovolemia developed within 24 hours from the completion of surgery, as judged by the Investigator.
4. Admitted to ICU or acute care floor for post-operative recovery and care, in relatively stable condition.
5. Subject, parent or guardian agrees to comply with the requirements of the protocol.
6. Subject, parent or guardian has signed an informed consent form (ICF) and a child assent form if appropriate.
7. Subject, parent or guardian has signed the Health Insurance Portability and Accountability Act (HIPAA) authorization.
Exclusion Criteria:
1. Intra-operative blood loss \> 50 mL/kg.
2. Severe hypoalbuminemia with serum albumin levels \< 1g/dL.
3. Known intolerance or allergy to albumin and/or plasma proteins.
4. Preterm neonates, defined as neonates with a gestational age of \<37 weeks (this criteria would only affect the 0-28 days group).
5. Burn and trauma patients.
6. Renal surgery.
7. Subjects with acute CNS injury or trauma would be excluded from the study.
8. Chronic renal insufficiency or acute renal failure (creatinine \> 1.5 of normal value or based on age-appropriate renal function parameters), or a history of renal transplantation.
9. Subjects with hypernatremia, defined as a Na level of ≥ 155 mEq/L.
10. Severe congestive heart failure (CHF) using one of the following classification systems: Ross Heart Failure Classification, modified Ross Heart Failure Classification, or New York University Pediatric Heart Failure Index (NYU PHFI).
11. Any concurrent medical, surgical or psychiatric condition that may, in the Investigator's opinion, affect the subject's ability to meet the protocol requirements.
12. Subject has participated in another interventional clinical study within 30 days prior to study enrollment. Subjects who are participating in another observational study are not excluded.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
12 Years
Study:
NCT01531803
Study Brief:
Protocol Section:
NCT01531803