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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT01564303
Eligibility Criteria:
Inclusion Criteria:
1. Subjects of 18 years old or older
2. CKD stage 3 according to GFR-MDRD equation.
3. Two consecutive stable plasma Creatinine levels during the last 2months.
4. Elective computed tomography (CT) with a nonionic low-osmolality radiographic contrast agent.
Exclusion Criteria:
1. Acute/ chronic renal failure. Acute renal failure is defined as a change in serum creatinine concentration of at least 0.5 mg/dL, or 25% from creatinine measured before the study to that of the day of the procedure.
2. Intercurrent illness: e.g. fever… etc.
3. Recent exposure to radiographic contrast media in the last month before enrollment.
4. Allergy to contrast agents, PDE inhibitors or NAC.
5. Hypotension
6. Pregnancy and lactation
7. Multiple Myeloma
8. Intravenous diuretics therapy
9. Therapy with any of the nephroprotective drugs 2 weeks before enrollment such as N.A.C. PED5 inhibitor or Carnitine for any reason.
10. Severe Congestive Heart Failure, Acute Myocardial Infarction, moderate to severe liver failure (Child-Pugh class B or C).
11. Concomitant use of Nitrates, CYP3A inhibitors (e.g Ketonazole, Itraconazole) or Inducers (e.g Rifampin)
12. Therapy with potential nephrotoxicity such as NSAID OR COX2 Inhibitors, Aminoglycosides, and Amphotericin B, Cisplatin, etc in the last two weeks before enrollment or within 5 days following the procedure.
13. Therapy with Metformin in the last 48 hours before the procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01564303
Study Brief:
Protocol Section:
NCT01564303