Aging Biomakers and ConTrast Induced Nephropathy (ACTIN) Trial

NCT ID: NCT02650336

Last Updated: 2016-01-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 592 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-09-30

Brief Summary

Biomarkers such as kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL) have been used for the early diagnosis of AKI, although with no definitive results. The investigators explored the association between plasma aging biomakers such as sklotho and contrast induced nephropathy in patients undergoing percutaneous coronary intervention (PCI) with contrast injection.

Detailed Description

Acute kidney injury represents an important clinical problem in hospitalized patients, with persistently high rates of mortality and morbidity. With an ever-increasing number of patients receiving intravascular injection of iodinated contrast media worldwide, contrast induced nephropathy (CIN) has become the third leading cause of hospital-acquired AKI. Approximately half of these cases are in patients undergoing cardiac catheterization procedures.

The prevention and early intervention of CIN has been hampered mainly by the lack of a consensus definition and the paucity of early predictive biomarkers to accurately identify high-risk patients. CIN is most frequently defined as an increase in serum creatinine (sCr) by 25-50% above the baseline, generally occurring within the first 24 h after contrast exposure, in the absence of other causes. However, sCr is an unreliable indicator during acute changes in kidney function, and alterations in sCr levels are not particularly sensitive or specific for small changes in the glomerular filtration rate (GFR)e, gender, race and intravascular volume. Biomarkers such as kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL) have been used for the early diagnosis of AKI, although with no definitive results.

Conditions

Contrast Induced Nephropathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

CIN proup

The occurrence of CIN was defined as an increase in serum creatinine of 0.5 mg/dL above the baseline value within 48-72 h after PCI. Follow-up SCr and BUN levels were measured 1, 2, and 3 days after the procedure.

contrast

Intervention Type: DRUG

a substance used to enhance the contrast of structures or fluids within the body in medical imaging. It is commonly used to enhance the visibility of blood vessels and the gastrointestinal tract

control group

The occurrence of CIN was defined as an increase in serum creatinine of 0.5 mg/dL above the baseline value within 48-72 h after PCI. Follow-up SCr and BUN levels were measured 1, 2, and 3 days after the procedure.

contrast

Intervention Type: DRUG

a substance used to enhance the contrast of structures or fluids within the body in medical imaging. It is commonly used to enhance the visibility of blood vessels and the gastrointestinal tract

Interventions

contrast

a substance used to enhance the contrast of structures or fluids within the body in medical imaging. It is commonly used to enhance the visibility of blood vessels and the gastrointestinal tract

Intervention Type: DRUG

Other Intervention Names

low-osmolar, non-ionic contrast medium

Eligibility Criteria

Inclusion Criteria

• Patients aged 18 years or older undergoing planed PCI were prospectively recruited

Exclusion Criteria

• Pregnancy
• Lactation
• Sepsis
• The intravascular administration of a contrast medium within the past 7 days, nephroprotective drug treatment (e.g., N-acetylcysteine, theophylline, sodium bicarbonate, prostaglandin E1)
• Nephrotoxic drug intake (e.g., non-steroidal anti-inflammatory drugs, metformin, aminoglycosides, cisplatin) within the past 7 days
• A history of serious allergic to contrast media
• Renal transplantation
• End-stage renal disease necessitating dialysis
• Severe concomitant disease of other systems.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xiao-dong Zhuang

department of cardiology, first affiliated hoapital of SYSU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zhimin du, MD

Role: PRINCIPAL_INVESTIGATOR

fitst affiliated hospital of SYSU

Locations

Xiaodong Zhaung

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

ACTIN-sysu

Identifier Type: -

Identifier Source: org_study_id