Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT04890704
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2021-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Curcuminoids and Contrast-induced Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D036381', 'term': 'Diarylheptanoids'}], 'ancestors': [{'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'stratified randomization and allocate concealment'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, double-blinded, randomized placebo-controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-13', 'studyFirstSubmitDate': '2021-05-13', 'studyFirstSubmitQcDate': '2021-05-13', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of AKI', 'timeFrame': '48 hours', 'description': 'the incidence of CI-AKI development between the addition of curcuminoids to standard protocol and standard protocol alone in patients who underwent CAG'}], 'secondaryOutcomes': [{'measure': 'AKI of any cause within seven days after CAG', 'timeFrame': '7 days', 'description': 'The incidence overallof AKI form any causes'}, {'measure': 'Change in eGFR', 'timeFrame': '0,7 days', 'description': 'The final eGFR compared to baseline eGFR before CAG'}, {'measure': 'Change in IL-6 and hs-CRP', 'timeFrame': '0.7 days', 'description': 'The final levels of inflammatory markers at the completion of study compare to baseline'}, {'measure': 'Adverse events', 'timeFrame': '7 days', 'description': 'The adverse events of curcuminoids'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['contrast-induced acute kidney injury', 'Curcuminoids', 'coronary angiography'], 'conditions': ['Acute Kidney Injury', 'Contrast Media Toxicity', 'Curcuminoid', 'Chronic Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '11979336', 'type': 'RESULT', 'citation': 'Nash K, Hafeez A, Hou S. Hospital-acquired renal insufficiency. Am J Kidney Dis. 2002 May;39(5):930-6. doi: 10.1053/ajkd.2002.32766.'}, {'pmid': '31141635', 'type': 'RESULT', 'citation': 'Mehran R, Dangas GD, Weisbord SD. Contrast-Associated Acute Kidney Injury. N Engl J Med. 2019 May 30;380(22):2146-2155. doi: 10.1056/NEJMra1805256. No abstract available.'}, {'pmid': '31700251', 'type': 'RESULT', 'citation': 'Morcos R, Kucharik M, Bansal P, Al Taii H, Manam R, Casale J, Khalili H, Maini B. Contrast-Induced Acute Kidney Injury: Review and Practical Update. Clin Med Insights Cardiol. 2019 Nov 1;13:1179546819878680. doi: 10.1177/1179546819878680. eCollection 2019.'}, {'pmid': '33081797', 'type': 'RESULT', 'citation': 'Kusirisin P, Chattipakorn SC, Chattipakorn N. Contrast-induced nephropathy and oxidative stress: mechanistic insights for better interventional approaches. J Transl Med. 2020 Oct 20;18(1):400. doi: 10.1186/s12967-020-02574-8.'}, {'pmid': '23314316', 'type': 'RESULT', 'citation': 'Tasanarong A, Vohakiat A, Hutayanon P, Piyayotai D. New strategy of alpha- and gamma-tocopherol to prevent contrast-induced acute kidney injury in chronic kidney disease patients undergoing elective coronary procedures. Nephrol Dial Transplant. 2013 Feb;28(2):337-44. doi: 10.1093/ndt/gfs525. Epub 2013 Jan 12.'}, {'pmid': '29130810', 'type': 'RESULT', 'citation': 'Weisbord SD, Gallagher M, Jneid H, Garcia S, Cass A, Thwin SS, Conner TA, Chertow GM, Bhatt DL, Shunk K, Parikh CR, McFalls EO, Brophy M, Ferguson R, Wu H, Androsenko M, Myles J, Kaufman J, Palevsky PM; PRESERVE Trial Group. Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine. N Engl J Med. 2018 Feb 15;378(7):603-614. doi: 10.1056/NEJMoa1710933. Epub 2017 Nov 12.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to evaluate the role of curcuminoids in the prevention of CI-AKI in CKD patients.The result of the study was prophylactic administration with curcuminoids in addition to standard treatment reduce the incidence of CI-AKI CKD patients undergoing elective CAG.', 'detailedDescription': 'This study was a single-center, prospective, double-blinded, randomized placebo-controlled trial in CKD patients undergoing elective coronary angiography (CAG) at Vajira hospital from October 2018 to March 2019. Patients were stratified according to baseline estimate glomerular filtration rate (eGFR) and diabetes status. They were randomized to Curcuminoids 1,500 milligrams per day starting 3 days before and 2 days after coronary procedure or placebo. The primary outcome was the development of CI-AKI, defined as serum creatinine rising ≥ 0.3 mg/dL within 48 hours after coronary angiography. The secondary outcomes were overall AKI incidences within 7 days after CAG, changes in eGFR, IL-6 hs-CRP, and other adverse events.\n\nA total of 60 patients were enrolled( 30 in curcuminoids group, and 30 in the control group). Overall AKI developed in 5 patients in control group and none in curcuminoids group (16.67% versus 0%, p-value 0.052). The results showed that curcuminoids could preserve changes in eGFR compared to the placebo group (-1.5 vs 2.5 mL/min/1.73m2, p-value \\<0.001 within 48 hours and -4 versus 1 mL/min/1.73m2, p-value 0.002 within 7 days). The high-sensitive C-reactive protein (hs-CRP) and IL-6 levels were not different between patients receiving curcuminoids and placebo. In curcuminoids group, 3 patients developed mild nausea and diarrhea that improved with supportive care. No serious adverse events were found in both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the patients undergoing elective CAG at Vajira hospital from October 2018 to March 2019 were included in the study\n* older than 18 years old\n* stable eGFR 15-60 mL/min/1.73m2 in last 3 months.\n\nExclusion Criteria:\n\n* dialysis-dependent\n* post-kidney transplantation\n* acute heart failure or critically ill\n* history of contrast or turmeric allergy\n* increasing of alanine aminotransferase (ALT) or alkaline phosphatase (ALP) more than three times of normal upper limits or post-cholecystectomy\n* history of AKI (as evidence by sCr change ≥ 0.3 mg/dL) within 14 days before the study - using medication included NSAIDs, warfarin, immunosuppression, N-acetyl cysteine, ascorbic acid or contrast agents within 14 days before the study\n* pregnancy or lactation o\n* denied consent .'}, 'identificationModule': {'nctId': 'NCT04890704', 'briefTitle': 'Curcuminoids and Contrast-induced Acute Kidney Injury', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bangkok Metropolitan Administration Medical College and Vajira Hospital'}, 'officialTitle': 'Curcuminoids Can Prevent Contrast-induced Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Elective Coronary Procedures: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '157/61'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Curcumioids', 'description': 'The investogators prescribed curcuminoids 1,500 mg/day . The regimen was curcuminoids 500 mg three times a day from three days before the procedure until two days after. All patients also received standard prophylaxis protocol which included 0.9% sodium chloride 1 mL/kg/hour, given 12 hours before and 12 hours after CAG unless contraindicated.', 'interventionNames': ['Drug: Curcuminoid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The placebo was identical capsule given three times daily and the remaining protocols were the same as the active group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Curcuminoid', 'type': 'DRUG', 'description': 'Patients were stratified according to baseline eGFR and diabetes status with 1:1 assignment into curcuminoids and placebo group. Curcuminoids (250 mg capsules) were purchased from the Government Pharmaceutical Organization of Thailand (Anti-ox® registration number 1A 1/60(H)), which contained curcumin: demethoxycurcumin: bis-demothoxycurcumin at the ratio of 1:0.5:0.2.', 'armGroupLabels': ['Curcumioids']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Identical capsules were used for the placebo from the same manufacturer.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10300', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Navamindradhiraj University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'After pub'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangkok Metropolitan Administration Medical College and Vajira Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Thananda Trakarnvanich', 'investigatorAffiliation': 'Bangkok Metropolitan Administration Medical College and Vajira Hospital'}}}}