Nephroprotective Effects of Carnitine and (PDE5) Inhibitor Agent Against Contrast Media-induced Nephropathy (CMN)
Contrast Media Induced Nephropathy
About this trial
This is an interventional supportive care trial for Contrast Media Induced Nephropathy focused on measuring Carnitine, Phosphodiesterase type 5 (PDE5) inhibitor, Contrast Media-induced Nephropathy (CMN)
Eligibility Criteria
Inclusion Criteria:
- Subjects of 18 years old or older
- CKD stage 3 according to GFR-MDRD equation.
- Two consecutive stable plasma Creatinine levels during the last 2months.
- Elective computed tomography (CT) with a nonionic low-osmolality radiographic contrast agent.
Exclusion Criteria:
- 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.
- Intercurrent illness: e.g. fever… etc.
- Recent exposure to radiographic contrast media in the last month before enrollment.
- Allergy to contrast agents, PDE inhibitors or NAC.
- Hypotension
- Pregnancy and lactation
- Multiple Myeloma
- Intravenous diuretics therapy
- Therapy with any of the nephroprotective drugs 2 weeks before enrollment such as N.A.C. PED5 inhibitor or Carnitine for any reason.
- Severe Congestive Heart Failure, Acute Myocardial Infarction, moderate to severe liver failure (Child-Pugh class B or C).
- Concomitant use of Nitrates, CYP3A inhibitors (e.g Ketonazole, Itraconazole) or Inducers (e.g Rifampin)
- 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.
- Therapy with Metformin in the last 48 hours before the procedure.
Sites / Locations
- Nazreth Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
Experimental
Experimental
No Intervention
2. Acetylcysteine group (NAC+S) , aside with the saline, will
CAR+S , aside with the saline, carnitne will be adminstrated
Phosphodiesterase type 5 inhibitor group (PDE5+S), aside with
Control group (S) will be treated without any extra agents
2. Acetylcysteine group (NAC+S) , aside with the saline, patients will be given orally Acetylcysteine at a dose of 600 mg twice daily, on the day before and on the day of administration of the contrast agent.
Carnitine group (Car+S), aside with the saline, patients will be administrated with 20 mg/kg carnitine over 10 minutes 2 hours prior to the administration of the contrast agent and 8 hours after CT.
4. Phosphodiesterase type 5 inhibitor group (PDE5+S), aside with the saline patients will be given orally 20 mg tablets of PDE5 Tadalafil once daily 2 hours prior to the administration of the contrast agent and in the subsequent day.
Control group ( S ) , which will be treated without any extra agents, just Saline (0.9 %) will be given I.V. at a rate of 1 ml per kilogram of body weight per hour for 12 hours before and 12 hours after administration of the contrast agent.