N-Acetyl Cystein and Contrast Nephropathy

NCT ID: NCT01820195

Last Updated: 2013-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 549 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-11-30

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.

Conditions

Chronic Kidney Disease Stage 2; Radiographic Contrast Agent Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intravenous N Acetyl Cystein

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

Group Type: ACTIVE_COMPARATOR

IV N-Acetyl Cystein

Intervention Type: DRUG

Bolus IV administration of 1200 mg N- Acetyl Cystein half an hour before contrast media administration

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 Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: DRUG

The patients in this group will be received both oral placebo and IV placebo

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

Group Type: ACTIVE_COMPARATOR

Oral N-Acetyl Cystein

Intervention Type: DRUG

Oral N-Acetyl Cystein 600 mg bid started the day before contrast administration and continue the day after exposure to contrast

Interventions

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

Intervention Type: DRUG

IV N-Acetyl Cystein

Bolus IV administration of 1200 mg N- Acetyl Cystein half an hour before contrast media administration

Intervention Type: DRUG

Placebo group

The patients in this group will be received both oral placebo and IV placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran Heart Center

OTHER

Sponsor Role: collaborator

Imam Khomeini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mohammad Reza Khatami

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammad R Khatami, MD

Role: STUDY_CHAIR

Nephrology Research Center

Ebrahin Kassaian, MD

Role: PRINCIPAL_INVESTIGATOR

Tehran Heart Center

Mojtaba Salarifar, MD

Role: PRINCIPAL_INVESTIGATOR

Tehran Heart Center

Ali Kazemi-Saeid, MD

Role: PRINCIPAL_INVESTIGATOR

Tehran Heart Center

Locations

Tehran Heart Center

Tehran, , Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Mohammad R Khatami, MD

Role: CONTACT

khatamis@sina.tums.ac.ir

Ebrahim Kassaeian, MD

Role: CONTACT

Facility Contacts

Mohammad R Khatami, MD

Role: primary

khatami@hbi.ir

00982161192659

Other Identifiers

THC-18043

Identifier Type: -

Identifier Source: org_study_id