N-Acetyl Cystein and Contrast Nephropathy

Radiographic Contrast Agent Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01820195
• Other study ID #: THC-18043
• Status: Recruiting
• Phase: Phase 3
• First received: March 25, 2013
• Last updated: March 27, 2013
• Start date: March 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2013
• Source: Imam Khomeini Hospital
• Contact: Mohammad R Khatami, MD
• Email: khatamis[@]sina.tums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 549
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 2
• Kidney Diseases
• Radiographic Contrast Agent Nephropathy
• Renal Insufficiency, Chronic

Intervention

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
• IV N-Acetyl Cystein
Bolus IV administration of 1200 mg N- Acetyl Cystein half an hour before contrast media administration
• Placebo group
The patients in this group will be received both oral placebo and IV placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran Heart Center	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Imam Khomeini Hospital	Tehran Heart Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in serum creatinine more than 25% of baseline		24 hours, 48 hours after exposure to contrast media	Yes
Secondary	Increase in serum creatinine more than 25% of baseline		The 5th day after exposure to contrast media	Yes