Curcuminoids and Contrast-induced Acute Kidney Injury
Primary Purpose
Acute Kidney Injury, Contrast Media Toxicity, Curcuminoid
Status
Completed
Phase
Early Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Curcuminoid
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Injury focused on measuring contrast-induced acute kidney injury, Curcuminoids, coronary angiography
Eligibility Criteria
Inclusion Criteria:
- All the patients undergoing elective CAG at Vajira hospital from October 2018 to March 2019 were included in the study
- older than 18 years old
- stable eGFR 15-60 mL/min/1.73m2 in last 3 months.
Exclusion Criteria:
- dialysis-dependent
- post-kidney transplantation
- acute heart failure or critically ill
- history of contrast or turmeric allergy
- increasing of alanine aminotransferase (ALT) or alkaline phosphatase (ALP) more than three times of normal upper limits or post-cholecystectomy
- 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
- pregnancy or lactation o
- denied consent .
Sites / Locations
- Navamindradhiraj University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Curcumioids
Placebo
Arm 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.
The placebo was identical capsule given three times daily and the remaining protocols were the same as the active group
Outcomes
Primary Outcome Measures
The incidence of AKI
the incidence of CI-AKI development between the addition of curcuminoids to standard protocol and standard protocol alone in patients who underwent CAG
Secondary Outcome Measures
AKI of any cause within seven days after CAG
The incidence overallof AKI form any causes
Change in eGFR
The final eGFR compared to baseline eGFR before CAG
Change in IL-6 and hs-CRP
The final levels of inflammatory markers at the completion of study compare to baseline
Adverse events
The adverse events of curcuminoids
Full Information
NCT ID
NCT04890704
First Posted
May 13, 2021
Last Updated
May 13, 2021
Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04890704
Brief Title
Curcuminoids and Contrast-induced Acute Kidney Injury
Official Title
Curcuminoids Can Prevent Contrast-induced Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Elective Coronary Procedures: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
A 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Contrast Media Toxicity, Curcuminoid, Chronic Kidney Diseases
Keywords
contrast-induced acute kidney injury, Curcuminoids, coronary angiography
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
prospective, double-blinded, randomized placebo-controlled study
Masking
Investigator
Masking Description
stratified randomization and allocate concealment
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Curcumioids
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo was identical capsule given three times daily and the remaining protocols were the same as the active group
Intervention Type
Drug
Intervention Name(s)
Curcuminoid
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Identical capsules were used for the placebo from the same manufacturer.
Primary Outcome Measure Information:
Title
The incidence of AKI
Description
the incidence of CI-AKI development between the addition of curcuminoids to standard protocol and standard protocol alone in patients who underwent CAG
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
AKI of any cause within seven days after CAG
Description
The incidence overallof AKI form any causes
Time Frame
7 days
Title
Change in eGFR
Description
The final eGFR compared to baseline eGFR before CAG
Time Frame
0,7 days
Title
Change in IL-6 and hs-CRP
Description
The final levels of inflammatory markers at the completion of study compare to baseline
Time Frame
0.7 days
Title
Adverse events
Description
The adverse events of curcuminoids
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All the patients undergoing elective CAG at Vajira hospital from October 2018 to March 2019 were included in the study
older than 18 years old
stable eGFR 15-60 mL/min/1.73m2 in last 3 months.
Exclusion Criteria:
dialysis-dependent
post-kidney transplantation
acute heart failure or critically ill
history of contrast or turmeric allergy
increasing of alanine aminotransferase (ALT) or alkaline phosphatase (ALP) more than three times of normal upper limits or post-cholecystectomy
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
pregnancy or lactation o
denied consent .
Facility Information:
Facility Name
Navamindradhiraj University
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
After pub
Citations:
PubMed Identifier
11979336
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.
Results Reference
result
PubMed Identifier
31141635
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.
Results Reference
result
PubMed Identifier
31700251
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.
Results Reference
result
PubMed Identifier
33081797
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.
Results Reference
result
PubMed Identifier
23314316
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.
Results Reference
result
PubMed Identifier
29130810
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.
Results Reference
result
Learn more about this trial
Curcuminoids and Contrast-induced Acute Kidney Injury
We'll reach out to this number within 24 hrs