Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-30 @ 12:19 PM
Study NCT ID:
NCT01820195
Status:
UNKNOWN
Last Update Posted:
2013-03-28
First Post:
2013-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
N-Acetyl Cystein and Contrast Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 549}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-27', 'studyFirstSubmitDate': '2013-03-25', 'studyFirstSubmitQcDate': '2013-03-27', 'lastUpdatePostDateStruct': {'date': '2013-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in serum creatinine more than 25% of baseline', 'timeFrame': '24 hours, 48 hours after exposure to contrast media'}], 'secondaryOutcomes': [{'measure': 'Increase in serum creatinine more than 25% of baseline', 'timeFrame': 'The 5th day after exposure to contrast media'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Contrast Nephropathy', 'N-Acetyl Cystein', 'Prophylaxy'], 'conditions': ['Chronic Kidney Disease Stage 2', 'Radiographic Contrast Agent Nephropathy']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 18\n* chronic Kidney disease stage 2-4\n* use of nephrotoxins in last week leading to angiography\n\nExclusion Criteria:\n\n* Acute kidney injury\n* concomitant use of other nephrotoxins\n* need of repeated imaging with contrast in five days after the first surgery\n* need for surgery in next five day after the contrast exposure\n* need of using nephrotoxins in next five days after contrast exposure'}, 'identificationModule': {'nctId': 'NCT01820195', 'briefTitle': 'N-Acetyl Cystein and Contrast Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Imam Khomeini Hospital'}, 'officialTitle': 'The Effect of N-Acetyl Cystein in Preventing Contrast Induced Nephropathy: A Double Blind Double Dummy Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'THC-18043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous N Acetyl Cystein', 'description': '1200 mg IV N- Acetyl Cystein half an hour before contrast administration. This group will also take oral placebo', 'interventionNames': ['Drug: IV N-Acetyl Cystein']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Drug: Placebo group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral N Acetyl Cystein', 'description': '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', 'interventionNames': ['Drug: Oral N-Acetyl Cystein']}], 'interventions': [{'name': 'Oral N-Acetyl Cystein', 'type': 'DRUG', 'description': 'Oral N-Acetyl Cystein 600 mg bid started the day before contrast administration and continue the day after exposure to contrast', 'armGroupLabels': ['Oral N Acetyl Cystein']}, {'name': 'IV N-Acetyl Cystein', 'type': 'DRUG', 'description': 'Bolus IV administration of 1200 mg N- Acetyl Cystein half an hour before contrast media administration', 'armGroupLabels': ['Intravenous N Acetyl Cystein']}, {'name': 'Placebo group', 'type': 'DRUG', 'description': 'The patients in this group will be received both oral placebo and IV placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Mohammad R Khatami, MD', 'role': 'CONTACT', 'email': 'khatami@hbi.ir', 'phone': '00982161192659'}], 'facility': 'Tehran Heart Center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Mohammad R Khatami, MD', 'role': 'CONTACT', 'email': 'khatamis@sina.tums.ac.ir'}, {'name': 'Ebrahim Kassaeian, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Mohammad R Khatami, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nephrology Research Center'}, {'name': 'Ebrahin Kassaian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tehran Heart Center'}, {'name': 'Mojtaba Salarifar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tehran Heart Center'}, {'name': 'Ali Kazemi-Saeid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tehran Heart Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imam Khomeini Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tehran Heart Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Mohammad Reza Khatami', 'investigatorAffiliation': 'Imam Khomeini Hospital'}}}}