N-Acetyl Cystein and Contrast Nephropathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Imam Khomeini Hospital
Sponsor:
Collaborator:
Tehran Heart Center
Information provided by (Responsible Party):
Mohammad Reza Khatami, Imam Khomeini Hospital
ClinicalTrials.gov Identifier:
NCT01820195
First received: March 25, 2013
Last updated: March 27, 2013
Last verified: March 2013

March 25, 2013
March 27, 2013
March 2013
August 2014   (final data collection date for primary outcome measure)
Increase in serum creatinine more than 25% of baseline [ Time Frame: 24 hours, 48 hours after exposure to contrast media ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01820195 on ClinicalTrials.gov Archive Site
Increase in serum creatinine more than 25% of baseline [ Time Frame: The 5th day after exposure to contrast media ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
  • Chronic Kidney Disease Stage 2
  • Radiographic Contrast Agent Nephropathy
  • 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
  • Active Comparator: Intravenous N Acetyl Cystein
    1200 mg IV N- Acetyl Cystein half an hour before contrast administration. This group will also take oral placebo
    Intervention: Drug: IV N-Acetyl Cystein
  • Placebo Comparator: Placebo
    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.
    Intervention: Drug: Placebo group
  • Active Comparator: 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
    Intervention: Drug: Oral N-Acetyl Cystein
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
549
November 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Mohammad R Khatami, MD khatamis@sina.tums.ac.ir
Contact: Ebrahim Kassaeian, MD
Iran, Islamic Republic of
 
NCT01820195
THC-18043
Yes
Mohammad Reza Khatami, Imam Khomeini Hospital
Imam Khomeini Hospital
Tehran Heart Center
Study Chair: Mohammad R Khatami, MD Nephrology Research Center
Principal Investigator: Ebrahin Kassaian, MD Tehran Heart Center
Principal Investigator: Mojtaba Salarifar, MD Tehran Heart Center
Principal Investigator: Ali Kazemi-Saeid, MD Tehran Heart Center
Imam Khomeini Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP