NCT01820195

N-Acetyl Cystein and Contrast Nephropathy

The Effect of N-Acetyl Cystein in Preventing Contrast Induced Nephropathy: A Double Blind Double Dummy Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 549 (estimated)
• Sponsor: Imam Khomeini Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease Stage 2
• Radiographic Contrast Agent Nephropathy

Interventions

Type	Name	Description
DRUG	Oral N-Acetyl Cystein	Oral N-Acetyl Cystein 600 mg bid started the day before contrast administration and continue the day after exposure to contrast
DRUG	IV N-Acetyl Cystein	Bolus IV administration of 1200 mg N- Acetyl Cystein half an hour before contrast media administration
DRUG	Placebo group	The patients in this group will be received both oral placebo and IV placebo

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-08-01
• Completion: 2014-11-01
• First posted: 2013-03-28
• Last updated: 2013-03-28

Locations

1 site across 1 country: Iran