N-Acetyl Cystein and Contrast Nephropathy
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| ClinicalTrials.gov Identifier: NCT01820195 |
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Recruitment Status : Unknown
Verified March 2013 by Mohammad Reza Khatami, Imam Khomeini Hospital.
Recruitment status was: Recruiting
First Posted : March 28, 2013
Last Update Posted : March 28, 2013
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Sponsor:
Imam Khomeini Hospital
Collaborator:
Tehran Heart Center
Information provided by (Responsible Party):
Mohammad Reza Khatami, Imam Khomeini Hospital
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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 |
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 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Diseases
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: IV N-Acetyl Cystein
Bolus IV administration of 1200 mg N- Acetyl Cystein half an hour before contrast media administration |
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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.
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Drug: Placebo group
The patients in this group will be received both oral placebo and IV placebo |
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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
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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 |
Primary Outcome Measures :
- Increase in serum creatinine more than 25% of baseline [ Time Frame: 24 hours, 48 hours after exposure to contrast media ]
Secondary Outcome Measures :
- Increase in serum creatinine more than 25% of baseline [ Time Frame: The 5th day after exposure to contrast media ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01820195
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 |
| 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 Key Record Dates |
| Last Update Posted: | March 28, 2013 |
| Last Verified: | March 2013 |
Keywords provided by Mohammad Reza Khatami, Imam Khomeini Hospital:
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Contrast Nephropathy N-Acetyl Cystein Prophylaxy |
Additional relevant MeSH terms:
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Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |