Curcuminoids and Contrast-induced Acute Kidney Injury

Sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04890704

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

12.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Contrast Media Toxicity Curcuminoid Chronic Kidney Diseases	Drug: Curcuminoid Drug: Placebo	Early Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective, double-blinded, randomized placebo-controlled studyprospective, double-blinded, randomized placebo-controlled study

Masking:

Single (Investigator)

Masking Description:

stratified randomization and allocate concealment

Primary Purpose:

Prevention

Official Title:

Curcuminoids Can Prevent Contrast-induced Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Elective Coronary Procedures: A Randomized Controlled Trial

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Mar 31, 2019

Actual Study Completion Date :

May 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Curcumioids 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.	Drug: Curcuminoid 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.
Placebo Comparator: Placebo The placebo was identical capsule given three times daily and the remaining protocols were the same as the active group	Drug: Placebo Identical capsules were used for the placebo from the same manufacturer.

Arm

Intervention/Treatment

Experimental: Curcumioids

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.

Drug: Curcuminoid

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.

Placebo Comparator: Placebo

The placebo was identical capsule given three times daily and the remaining protocols were the same as the active group

Drug: Placebo

Identical capsules were used for the placebo from the same manufacturer.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 .