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
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease Stage 2
Radiographic Contrast Agent Nephropathy
Drug: Oral N-Acetyl Cystein
Drug: IV N-Acetyl Cystein
Drug: Placebo group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of N-Acetyl Cystein in Preventing Contrast Induced Nephropathy: A Double Blind Double Dummy Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Imam Khomeini Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Increase in serum creatinine more than 25% of baseline [ Time Frame: The 5th day after exposure to contrast media ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 549
Study Start Date: March 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: IV N-Acetyl Cystein
Bolus IV administration of 1200 mg N- Acetyl Cystein half an hour before contrast media administration
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.
Drug: Placebo group
The patients in this group will be received both oral placebo and IV placebo
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
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01820195

Contacts
Contact: Mohammad R Khatami, MD khatamis@sina.tums.ac.ir
Contact: Ebrahim Kassaeian, MD

Locations
Iran, Islamic Republic of
Tehran Heart Center Recruiting
Tehran, Iran, Islamic Republic of
Contact: Mohammad R Khatami, MD    00982161192659    khatami@hbi.ir   
Sponsors and Collaborators
Imam Khomeini Hospital
Tehran Heart Center
Investigators
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
  More Information

No publications provided

Responsible Party: Mohammad Reza Khatami, Associate professor, Imam Khomeini Hospital
ClinicalTrials.gov Identifier: NCT01820195     History of Changes
Other Study ID Numbers: THC-18043
Study First Received: March 25, 2013
Last Updated: March 27, 2013
Health Authority: Iran: Ministry of Health

Keywords provided by Imam Khomeini Hospital:
Contrast Nephropathy
N-Acetyl Cystein
Prophylaxy

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 23, 2014