N-Acetyl Cystein and Contrast Nephropathy

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	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

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	549 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Care Provider, 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
Study Start Date :	March 2013
Estimated Primary Completion Date :	August 2014
Estimated Study Completion Date :	November 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Increase in serum creatinine more than 25% of baseline [ Time Frame: 24 hours, 48 hours after exposure to contrast media ]

Secondary Outcome Measures :

1. Increase in serum creatinine more than 25% of baseline [ Time Frame: The 5th day after exposure to contrast media ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Mohammad Reza Khatami, Associate professor, Imam Khomeini Hospital
ClinicalTrials.gov Identifier:	NCT01820195 History of Changes
Other Study ID Numbers:	THC-18043
First Posted:	March 28, 2013
Last Update Posted:	March 28, 2013
Last Verified:	March 2013

Keywords provided by Mohammad Reza Khatami, Imam Khomeini Hospital:

Contrast Nephropathy; N-Acetyl Cystein; Prophylaxy

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Renal Insufficiency