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:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT00026702
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Subjects \>= 3 years old. Both male and female subjects will be recruited without regard to race or ethnic origin.
2. Either:
1. Normal (creatinine level \< 1.3 mg/dl for adults; creatinine level \< standard nomogram for children), OR
2. Oliguria due to volume depletion (indicated by oliguria and Fractional Excretion of Sodium (FENa) of less than 1%), OR
3. High risk of ARF, including surgery, transplantation, nephrotoxic antibiotics, or bone marrow transplant. OR
4. Evidence of ARF as defined by an acute progressive rise in serum creatinine (at least 50% increase within 24 hours preceding enrollment) without stabilization or recovery, despite optimization of hemodynamic fluid status and correction of any known pharmacologic, pre-renal, or post-renal etiologic factors. OR
5. Urinary tract infection (to serve as control for ARF studies), OR
6. Established chronic kidney disease (to serve as control for ARF studies).
EXCLUSION CRITERIA:
1. Minors who do not give clear assent, even with parental consent
2. Existence of any other condition which would complicate the implementation or interpretation of the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT00026702
Study Brief:
Protocol Section:
NCT00026702