Suspended

The Effect of N-Acetyl Cystein in Preventing Contrast Induced Nephropathy: A Double Blind Double Dummy Randomized Controlled Trial

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What is being tested

IV N-Acetyl Cystein

+ Placebo group

+ Oral N-Acetyl Cystein

Drug
Who is being recruted

Urogenital Diseases+9

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 80 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 3
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorImam Khomeini Hospital
Study ContactMohammad R Khatami, MDMore contacts
Last updated: March 28, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorImam Khomeini Hospital
Study ContactMohammad R Khatami, MDMore contacts
Last updated: March 28, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

549 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, Chronic

Criteria

3 inclusion criteria required to participate
Age more than 18

chronic Kidney disease stage 2-4

use of nephrotoxins in last week leading to angiography

5 exclusion criteria prevent from participating
Acute kidney injury

concomitant use of other nephrotoxins

need for surgery in next five day after the contrast exposure

need of repeated imaging with contrast in five days after the first surgery

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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.

Group III

Active Comparator
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Tehran Heart Center

Tehran, IranOpen Tehran Heart Center in Google Maps
SuspendedOne Study Center