Clinical trial NCT01820195: N-Acetyl Cystein and Contrast Nephropathy
Official title: The Effect of N-Acetyl Cystein in Preventing Contrast Induced Nephropathy: A Double Blind Double Dummy Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Kidney Disease Stage 2
Radiographic Contrast Agent Nephropathy
Keywords: Contrast Nephropathy
N-Acetyl Cystein
Prophylaxy
Lead sponsor: Imam Khomeini Hospital
Sponsor class: OTHER
Collaborators: name: Tehran Heart Center
First posted: 2013-03-28
Enrollment: 549
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Increase in serum creatinine more than 25% of baseline
timeFrame: 24 hours, 48 hours after exposure to contrast media
Secondary outcomes:
measure: Increase in serum creatinine more than 25% of baseline
timeFrame: The 5th day after exposure to contrast media
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran Heart Center
Study officials:
affiliation: Nephrology Research Center
name: Mohammad R Khatami, MD
role: STUDY_CHAIR
affiliation: Tehran Heart Center
name: Ebrahin Kassaian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Mojtaba Salarifar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Ali Kazemi-Saeid, MD
role: PRINCIPAL_INVESTIGATOR
References: