Curcuminoids and Contrast-induced Acute Kidney Injury

Early Phase 1

Completed

• Conditions: Acute Kidney Injury; Contrast Media Toxicity; Curcuminoid; Chronic Kidney Diseases
• Interventions: Drug: Placebo; Drug: Curcuminoid

• Registration Number: NCT04890704
• Lead Sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital

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.

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-03-31
• Study Completion: 2019-05-31
• Status Verified: 2021-05
• Study First Submitted: 2021-05-13
• Study First Submitted QC: 2021-05-13
• Last Update Submitted: 2021-05-13
• Study First Posted: 2021-05-18
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The placebo was identical capsule given three times daily and the remaining protocols were the same as the active group
Curcumioids	Curcuminoid	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Navamindradhiraj University; 🇹🇭 Bangkok, Thailand