Nephroprotective Effects of Carnitine and (PDE5) Inhibitor Agent Against Contrast Media-induced Nephropathy (CMN)

• Status: Unknown status
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

CIAKI is a common iatrogenic. Up to date the suggested treatments for CIAKI are partially effective and have not been approved by the Food and Drug Administration yet. The lack of effective nephroprotective drug for CIAKI, emphasizes the need not only for additional new drugs but also for new strategies that might also clarify CIAKI pathophysiology. To the best of our knowledge, the potentially beneficial effect of carnitine and PDE5 inhibitors on CIAKI prevention has not been examined, so far.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Nazareth Hospital
• Collaborator: Western Galilee Hospital-Nahariya
• Treatments: Acetylcysteine; N-monoacetylcystine; Phosphodiesterase 5 Inhibitors

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.