An observational study in Contrast-induced Nephropathy, sponsored by Eva de Miguel Balsa. Completed at 1 site in Spain. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-08-17.
Sponsored by Eva de Miguel Balsa · Observational
Radiological examinations that require the administration of iodinated contrasts (IC) for diagnostic and therapeutic purposes are essential in current clinical practice, and their use in interventional procedures has been progressively increasing.
IC can cause kidney damage, so there is caution in their use in at-risk populations. This fact may limit its diagnostic use, with data on underutilization of interventional techniques in patients with renal insufficiency, which worsen their prognosis.
In addition, once the use of IC contrasts is decided, preventive measures, such as hyperhydration,are used and can have potential side effects, especially in patients at risk of heart failure (acute coronary syndrome, low left ventricular ejection fraction).
New biomarkers of kidney damage have recently been developed, based on the detection of molecules expressed by the kidney in situations of early damage. The quantitative determination of cell cycle arrest proteins (Tissue Inhibitor of metalloproteinase 2 (TIMP2) and Insulin-Like Growth Factor Binding Protein -7 (IGFBP7)) can be predictive of the development of moderate to severe contrast-associated acute kidney injury.
Urinary determination of [TIMP-2] x [IGFBP7] in patients with ACS (acute coronary syndromes) before cardiac catheterization would allow early identification of those patients vulnerable to IC-induced toxicity and adjustment of preventive measures.
Urinary determination of [TIMP-2] x [IGFBP7] in patients with ACS undergoing cardiac catheterization would allow early identification of those patients vulnerable to IC-induced toxicity and adjustment of both appropriate preventive measures.
A prospective, descriptive observational study will be carried out to determine sensitivity and specificity of the urinary determination of TIMP2-IGFBP7 and predictive values in the early diagnosis of contrast-associated acute kidney injury (AKI) in patients admitted to the Coronary Care Unit (CCU) in a spanish hospital.
OBJECTIVES
Evaluate these parameters according to the patient's initial risk level:
A single determination (10 ml of fresh urine) should be collected in a sterile container and the laboratory should centrifuge them within the time of collection. Neither the attending physicians nor the investigators will know the results, and the treatment will not be influenced.
The result is reported as a single value which is the concentration of TIMP-2 (ng / mL) multiplied by the concentration of IGFBP7 (ng / mL) divided by 1000. The result is reported without any unit or concentrations of individual biomarkers. As previously reported, a value of> 0.3 identifies patients with a high probability of presenting a moderate to severe AKI (acute kidney injury) in 12 hours, while a value of ≤ 0.3 identifies patients with a low risk of developing a moderate to serious AKI
An aliquot of urine will be stored at -80 ° C in the Clinical Analysis Department
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 194 is close to the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →This is the only study on the registry with Eva de Miguel Balsa as lead sponsor.
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Patients older than 21 years, with moderate / high risk acute coronary syndrome according to GRACE score and exposed to intra-arterial iodinated contrast media
Exclusion Criteria:
Adults with moderate / high risk acute coronary syndrome undergoing coronary intervention. The sample will be selected consecutively, including patients admitted to the Cardiac Coronary Unit and who require a radiological test with intra-arterial IC administration, for diagnostic or diagnostic / therapeutic purposes
Diagnostic Test: Urinary determination of TIMP-2/ IGFBP7
Urinary determination of TIMP2-IGFBP7 in the an urine sample obtained within 12 hours prior to contrast administration. A single determination will be made, which will be sent to the laboratory. The doctor who treats the patient will not know the result of the test, and the treatment will not be influenced by the result. According to the manufacturer, 10 ml of fresh urine should be collected in a sterile container and the laboratory should centrifuge them within the time of collection. The result is reported as a single value calculated as the concentration of TIMP-2 (ng / mL) multiplied by the concentration of IGFBP7 (ng / mL) divided by 1000. The result is reported without units.
Contrast-Associated Acute Kidney Injury
Absolute increase of 0.3 mg / dl in the creatinine value and / or a relative increase greater than 1.5 times the baseline creatinine value, measured at 48 and 72 hours after exposure to contrast.
Time frame: up to 72 hours of exposure
Mortality
Patients who die during their hospital stay for any reason
Time frame: up to 30 days
Need of renal replacement techniques
Hemodialysis, peritoneal dialysis or continuous renal replacement techniques,
Time frame: From exposure to contrasts to three months
Plan to share: Undecided
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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