N-Acetyl Cystein and Contrast Nephropathy

Phase 3

• Conditions: Chronic Kidney Disease Stage 2; Radiographic Contrast Agent Nephropathy
• Interventions: Drug: IV N-Acetyl Cystein; Drug: Placebo group; Drug: Oral N-Acetyl Cystein

• Registration Number: NCT01820195
• Lead Sponsor: Imam Khomeini Hospital

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.

Study Timeline

• Status Verified: 2013-03
• Study Start: 2013-03
• Study First Submitted: 2013-03-25
• Study First Submitted QC: 2013-03-27
• Last Update Submitted: 2013-03-27
• Study First Posted: 2013-03-28
• Last Update Posted: 2013-03-28
• Primary Completion: 2014-08
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 549

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous N Acetyl Cystein	IV N-Acetyl Cystein	1200 mg IV N- Acetyl Cystein half an hour before contrast administration. This group will also take oral placebo
Placebo	Placebo group	Patients on both oral placebo and IV placebo just like patients on oral and IV N-acetyl cystein groups in regard of dose and timing.
Oral N Acetyl Cystein	Oral N-Acetyl Cystein	Patients on 600 mg oral N-Acetyl Cystein bid started at the day before contrast exposure and continue until the next day of contrast exposure.These patients will also take IV placebo

Primary Outcome Measures

Name	Time	Method
Increase in serum creatinine more than 25% of baseline	24 hours, 48 hours after exposure to contrast media

Secondary Outcome Measures

Name	Time	Method
Increase in serum creatinine more than 25% of baseline	The 5th day after exposure to contrast media

Trial Locations

Locations (1)

Tehran Heart Center; 🇮🇷 Tehran, Iran, Islamic Republic of