search
Back to results

N-Acetyl Cystein and Contrast Nephropathy

Primary Purpose

Chronic Kidney Disease Stage 2, Radiographic Contrast Agent Nephropathy

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Oral N-Acetyl Cystein
IV N-Acetyl Cystein
Placebo group
Sponsored by
Imam Khomeini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease Stage 2 focused on measuring Contrast Nephropathy, N-Acetyl Cystein, Prophylaxy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tehran Heart CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Intravenous N Acetyl Cystein

Placebo

Oral N Acetyl Cystein

Arm Description

1200 mg IV N- Acetyl Cystein half an hour before contrast administration. This group will also take oral 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.

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

Outcomes

Primary Outcome Measures

Increase in serum creatinine more than 25% of baseline

Secondary Outcome Measures

Increase in serum creatinine more than 25% of baseline

Full Information

First Posted
March 25, 2013
Last Updated
March 27, 2013
Sponsor
Imam Khomeini Hospital
Collaborators
Tehran Heart Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01820195
Brief Title
N-Acetyl Cystein and Contrast Nephropathy
Official Title
The Effect of N-Acetyl Cystein in Preventing Contrast Induced Nephropathy: A Double Blind Double Dummy Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imam Khomeini Hospital
Collaborators
Tehran Heart Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 2, Radiographic Contrast Agent Nephropathy
Keywords
Contrast Nephropathy, N-Acetyl Cystein, Prophylaxy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
549 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous N Acetyl Cystein
Arm Type
Active Comparator
Arm Description
1200 mg IV N- Acetyl Cystein half an hour before contrast administration. This group will also take oral placebo
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Oral N Acetyl Cystein
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Oral N-Acetyl Cystein
Intervention Description
Oral N-Acetyl Cystein 600 mg bid started the day before contrast administration and continue the day after exposure to contrast
Intervention Type
Drug
Intervention Name(s)
IV N-Acetyl Cystein
Intervention Description
Bolus IV administration of 1200 mg N- Acetyl Cystein half an hour before contrast media administration
Intervention Type
Drug
Intervention Name(s)
Placebo group
Intervention Description
The patients in this group will be received both oral placebo and IV placebo
Primary Outcome Measure Information:
Title
Increase in serum creatinine more than 25% of baseline
Time Frame
24 hours, 48 hours after exposure to contrast media
Secondary Outcome Measure Information:
Title
Increase in serum creatinine more than 25% of baseline
Time Frame
The 5th day after exposure to contrast media

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad R Khatami, MD
Email
khatamis@sina.tums.ac.ir
First Name & Middle Initial & Last Name or Official Title & Degree
Ebrahim Kassaeian, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad R Khatami, MD
Organizational Affiliation
Nephrology Research Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ebrahin Kassaian, MD
Organizational Affiliation
Tehran Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mojtaba Salarifar, MD
Organizational Affiliation
Tehran Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali Kazemi-Saeid, MD
Organizational Affiliation
Tehran Heart Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehran Heart Center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad R Khatami, MD
Phone
00982161192659
Email
khatami@hbi.ir

12. IPD Sharing Statement

Learn more about this trial

N-Acetyl Cystein and Contrast Nephropathy

We'll reach out to this number within 24 hrs