Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04890704
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2021-05-13
Brief Title:
Curcuminoids and Contrast-induced Acute Kidney Injury
Sponsor:
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Organization:
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Study Overview
Official Title:
Curcuminoids Can Prevent Contrast-induced Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Elective Coronary Procedures A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study was to evaluate the role of curcuminoids in the prevention of CI-AKI in CKD patientsThe 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 1500 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 03 mgdL 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 1667 versus 0 p-value 0052 The results showed that curcuminoids could preserve changes in eGFR compared to the placebo group -15 vs 25 mLmin173m2 p-value 0001 within 48 hours and -4 versus 1 mLmin173m2 p-value 0002 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
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 1667 versus 0 p-value 0052 The results showed that curcuminoids could preserve changes in eGFR compared to the placebo group -15 vs 25 mLmin173m2 p-value 0001 within 48 hours and -4 versus 1 mLmin173m2 p-value 0002 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None