Curcuminoids and Contrast-induced Acute Kidney Injury

NCT04890704 | Completed Early Phase 1 DMC

• 1 other identifier: 157/61
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Contrast Media Toxicity; Curcuminoid; Chronic Kidney Diseases

Keywords

contrast-induced acute kidney injury; Curcuminoids; coronary angiography

Outcome Measures

Primary Outcomes (1)

• 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

  48 hours

Secondary Outcomes (4)

• AKI of any cause within seven days after CAG

  7 days

• Change in eGFR

  0,7 days

• Change in IL-6 and hs-CRP

  0.7 days

• Adverse events

  7 days

Study Arms (2)

Curcumioids

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Curcuminoid DRUG

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.

Curcumioids

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Bangkok Metropolitan Administration Medical College and Vajira Hospital: lead

Study Sites (1)

Navamindradhiraj University

Bangkok, 10300, Thailand

Location

Related Publications (6)

• 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.

  PMID: 11979336 RESULT

• 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.

  PMID: 31141635 RESULT

• 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.

  PMID: 31700251 RESULT

• 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.

  PMID: 33081797 RESULT

• 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.

  PMID: 23314316 RESULT

• 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.

  PMID: 29130810 RESULT

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Interventions

Diarylheptanoids

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: stratified randomization and allocate concealment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: prospective, double-blinded, randomized placebo-controlled study

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 18, 2021
• Study Start: October 1, 2018
• Primary Completion: March 31, 2019
• Study Completion: May 31, 2019
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)