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.

Study Overview

• Status: Unknown
• Conditions: Radiographic Contrast Agent Nephropathy; Chronic Kidney Disease Stage 2
• Intervention / Treatment: Drug: IV N-Acetyl Cystein; Drug: Placebo group; Drug: Oral N-Acetyl Cystein

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 Type: Interventional
• Enrollment (Anticipated): 549
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mohammad R Khatami, MD; Email: khatamis@sina.tums.ac.ir
• Study Contact Backup: Name: Ebrahim Kassaeian, MD

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Tehran Heart Center
    • Contact: Mohammad R Khatami, MD; Phone Number: 00982161192659; Email: khatami@hbi.ir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Imam Khomeini Hospital
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): November 1, 2014

Study Registration Dates

• First Submitted: March 25, 2013
• First Submitted That Met QC Criteria: March 27, 2013
• First Posted (Estimate): March 28, 2013

Study Record Updates

• Last Update Posted (Estimate): March 28, 2013
• Last Update Submitted That Met QC Criteria: March 27, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Contrast Nephropathy; N-Acetyl Cystein; Prophylaxy
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: THC-18043