Clinical trial NCT02650336: Aging Biomakers and ConTrast Induced Nephropathy (ACTIN) Trial
Official title: Aging Biomakers and ConTrast Induced Nephropathy (ACTIN) Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contrast Induced Nephropathy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 years or older undergoing planed PCI at the institution of first affiliated hospital of SYSU were prospectively recruited between May 2014 and July 2015. The exclusion criteria were 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, and severe concomitant disease of other systems.

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.

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.

Primary outcomes:
measure: The association between plasma aging biomakers and contrast induced nephropathy
timeFrame: 48-72 hours
Secondary outcomes:
measure: The association between plasma aging biomakers and in-hospital MACE in patients undergoing percutaneous coronary intervention (PCI) with contrast injection.
timeFrame: 30 days, 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Xiaodong Zhaung
state: Guangdong
Study officials:
affiliation: fitst affiliated hospital of SYSU
name: zhimin du, MD
role: PRINCIPAL_INVESTIGATOR
References: