Nephroprotective Effects of Carnitine and (PDE5) Inhibitor Agent Against Contrast Media-induced Nephropathy (CMN)
This study is not yet open for participant recruitment.
Verified March 2012 by The Nazareth Hospital, Israel
Sponsor:
The Nazareth Hospital
Collaborator:
Western Galilee Hospital-Nahariya
Information provided by (Responsible Party):
The Nazareth Hospital, The Nazareth Hospital, Israel
ClinicalTrials.gov Identifier:
NCT01564303
First received: March 22, 2012
Last updated: March 24, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Contrast Media Induced Nephropathy |
Drug: Acetylcysteine, Phosphodiesterase type 5 inhibitor ,Carnitine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Potentially Nephroprotective Effects of Carnitine and Phosphodiesterase Type 5 (PDE5) Inhibitor Agent Against Contrast Media-induced Nephropathy (CMN): A Double Blind Randomized Study |
Resource links provided by NLM:
Further study details as provided by The Nazareth Hospital, Israel:
Primary Outcome Measures:
- Kidney functioning biomarker [ Time Frame: NGAL and creatinine will be assessed before CT and 2, 6, 12,24,48,120 hours after CT ] [ Designated as safety issue: Yes ]7 time points over 6 days
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 2. Acetylcysteine group (NAC+S) , aside with the saline, will
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.
|
Drug: Acetylcysteine, Phosphodiesterase type 5 inhibitor ,Carnitine
to evaluate the effect of the above agents on Kidney functioning parameters
|
|
Experimental: CAR+S , aside with the saline, carnitne will be adminstrated
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.
|
Drug: Acetylcysteine, Phosphodiesterase type 5 inhibitor ,Carnitine
to evaluate the effect of the above agents on Kidney functioning parameters
|
|
Experimental: Phosphodiesterase type 5 inhibitor group (PDE5+S), aside with
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.
|
Drug: Acetylcysteine, Phosphodiesterase type 5 inhibitor ,Carnitine
to evaluate the effect of the above agents on Kidney functioning parameters
|
|
No Intervention: Control group (S) will be treated without any extra agents
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.
|
Drug: Acetylcysteine, Phosphodiesterase type 5 inhibitor ,Carnitine
to evaluate the effect of the above agents on Kidney functioning parameters
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564303
Contacts
| Contact: najlah hamati | 046028888 | nana@nazhosp.com |
Locations
| Israel | |
| Nazreth Hospital | Not yet recruiting |
| Nazareth, Israel, 16100 | |
| Contact: amir abed, msc 0507209343 amir_abed@nazhosp.com | |
Sponsors and Collaborators
The Nazareth Hospital
Western Galilee Hospital-Nahariya
More Information
No publications provided
| Responsible Party: | The Nazareth Hospital, Zaher Armaly M.D. , Head of Nephrology Department, The Nazareth Hospital, Israel |
| ClinicalTrials.gov Identifier: | NCT01564303 History of Changes |
| Other Study ID Numbers: | nazh7343ctil |
| Study First Received: | March 22, 2012 |
| Last Updated: | March 24, 2012 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by The Nazareth Hospital, Israel:
|
Carnitine Phosphodiesterase type 5 (PDE5) inhibitor Contrast Media-induced Nephropathy (CMN) |
Additional relevant MeSH terms:
|
Kidney Diseases Urologic Diseases Acetylcysteine N-monoacetylcystine Carnitine Phosphodiesterase 5 Inhibitors Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Expectorants Respiratory System Agents |
Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes Vitamin B Complex Vitamins Micronutrients Growth Substances Phosphodiesterase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013