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N-Acetyl Cystein and Contrast Nephropathy

NCT01820195 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 549

Last updated 2013-03-28

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Disease Stage 2
  • Radiographic Contrast Agent Nephropathy

Interventions

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

Sponsors & Collaborators

  • Tehran Heart Center

    collaborator OTHER

  • Imam Khomeini Hospital

    lead OTHER

Principal Investigators

  • Mohammad R Khatami, MD · Nephrology Research Center

  • Ebrahin Kassaian, MD · Tehran Heart Center

  • Mojtaba Salarifar, MD · Tehran Heart Center

  • Ali Kazemi-Saeid, MD · Tehran Heart Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-08-31
Completion
2014-11-30

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01820195 on ClinicalTrials.gov