Acute Kidney Injury, Chronic Kidney Diseases, Contrast Media Toxicity, Curcuminoid
Conditions
Keywords
contrast-induced acute kidney injury, Curcuminoids, coronary angiography
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.
Interventions
DRUGCurcuminoid
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.
DRUGPlacebo
Identical capsules were used for the placebo from the same manufacturer.
Sponsors
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
stratified randomization and allocate concealment
Intervention model description
prospective, double-blinded, randomized placebo-controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of AKI | 48 hours | the incidence of CI-AKI development between the addition of curcuminoids to standard protocol and standard protocol alone in patients who underwent CAG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AKI of any cause within seven days after CAG | 7 days | The incidence overallof AKI form any causes |
| Change in eGFR | 0,7 days | The final eGFR compared to baseline eGFR before CAG |
| Change in IL-6 and hs-CRP | 0.7 days | The final levels of inflammatory markers at the completion of study compare to baseline |
| Adverse events | 7 days | The adverse events of curcuminoids |
Countries
Thailand
Outcome results
None listed