N-GAL Allows Intensive Treatment of Contrast Induced Nephropathy

Study Overview
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Brief Summary
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Patients who undergo urgent/emergency coronary angiography can not receive any preventive treatment of contrast induced nephropathy. We tested the hypothesis that Neutrophil gelatinase-associated lipocalin (NGAL), a new biomarker predictive for AKI, allows early and effective treatment of contrast induced nephropathy in patients with urgent/emergency coronary angiography

Detailed Description
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Background Patients who undergo urgent/emergency coronary angiography can not receive any preventive treatment of contrast induced nephropathy. An acute kidney injury is generally detected too late to allow effective intervention in patients who undergo urgent/emergency coronary angiography. Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy. Purpose The primary objective of this study is to to test the hypothesis that a NGAL-driven early intensive strategy can reduce the occurrence of contrast induced nephropathy in patients with urgent/emergency coronary angiography

Official Title
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Neutrophil gElatinase-associated Lipocalin alloWs Intensive treatMent Of cOntrast Induced Nephropathy in Patients With Urgent/Emergency Percutaneous Coronary Intervention

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Intensive treatment with sodium bicarbonate
* Drug: Standard treatment with saline infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication to urgent/emergency coronary angiography Normal renal function (eGFR> 60 ml/min/1.73 m2) Moderate or high Mehran's risk score for CIN (>11). Able to understand and willing to sign the informed consent form Exclusion Criteria: • Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intensive treatment group<br>Patients will receive high concentration sodium bicarbonate (3 ml/kg/h for 1 hour, then 1 ml/kg/h for 7 h) followed by i.v. saline for 48 h after PCI in case of abnormal NGAL findings | Drug: Intensive treatment with sodium bicarbonate<br>* i.v., sodium bicarbonate (3 ml/kg/h for 1 hour, then 1 ml/kg/h for 7 h) followed by i.v. saline for 48 h in case of abnormal NGAL findings<br>|
| Active Comparator: Standard treament group<br>Patients will receive i.v. 1 ml/kg/h saline infusion for 48 h after PCI in case of abnormal NGAL findings | Drug: Standard treatment with saline infusion<br>* i.v. 1 ml/kg/h saline infusion for 48 h in case of abnormal NGAL findings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of contrast induced nephropathy | Absolute increase in serum creatinine equal to or greater than 0.5 mg/dL detected 48 hours after angiography as compared with baseline value | Baseline and 48 hours after angiography | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-angiographic changes in renal function parameters | Changes in creatinine levels and estimated glomerular filtration rate at 48-hour evaluation after angiography as compared with baseline values | Baseline and 48 hours after angiography | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contrast-induced nephropathy