Chronic Kidney Disease Stage 2, Radiographic Contrast Agent Nephropathy
Conditions
Keywords
Contrast Nephropathy, N-Acetyl Cystein, Prophylaxy
Brief summary
There are many controversies about the role of N-Acetyl Cystein in preventing of contrast nephropathy. These contradictory results may be due to different criteria for patients' selection, different end points, different type and dose of N-Acetyl Cystein administration and finally different prophylactic measures other than N-Acetyl Cystein. The investigators try to enroll a double blind double dummy study with a good power to compare the effect of this drug both in the form of oral and intravenous against the placebo in preventing the contrast nephropathy in the patients whom undergo coronary angiography/angioplasty.
Detailed description
Contrast Nephropathy is the third cause of acute kidney injury in hospitalized patients. The morbidity and mortality of this disorder is considerable. There is no treatment for this condition and all measures should be taken into account to prevent this complication. Among the all prophylactic measures hydration and the dose ant type of contrast are the only factors that have been proved to be effective in preventing contrast nephropathy. N-Acetyl Cystein is an antioxidant agents that may be effective in different aspects of medicine, but it,s use in this condition is controversial. While some studies showed it is effective in prevention of contrast nephropathy, others showed no benefit. Different studies used different dose and route of administration. So more clinical trials with good power are needed to compare different oral Vs IV administration of the drug in a randomized double blinded clinical trial. In this study we allocate the eligible patients with chronic kidney diseases stages 2 to 4 to three groups. Oral N-Acetyl Cystein group, IV N-Acetyl Cystein group, placebo group. All group will be matched according to stages of chronic kidney diseases, diabetes, anemia, heart failure, age and sex.
Interventions
DRUGOral N-Acetyl Cystein
Oral N-Acetyl Cystein 600 mg bid started the day before contrast administration and continue the day after exposure to contrast
DRUGIV N-Acetyl Cystein
Bolus IV administration of 1200 mg N- Acetyl Cystein half an hour before contrast media administration
DRUGPlacebo group
The patients in this group will be received both oral placebo and IV placebo
Sponsors
Tehran Heart Center
Imam Khomeini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age more than 18 * chronic Kidney disease stage 2-4 * use of nephrotoxins in last week leading to angiography
Exclusion criteria
* Acute kidney injury * concomitant use of other nephrotoxins * need of repeated imaging with contrast in five days after the first surgery * need for surgery in next five day after the contrast exposure * need of using nephrotoxins in next five days after contrast exposure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in serum creatinine more than 25% of baseline | 24 hours, 48 hours after exposure to contrast media |
Secondary
| Measure | Time frame |
|---|---|
| Increase in serum creatinine more than 25% of baseline | The 5th day after exposure to contrast media |
Countries
Iran
Contacts
Primary ContactMohammad R Khatami, MD
Backup ContactEbrahim Kassaeian, MD
Outcome results
None listed