N-GAL Allows Intensive Treatment of Contrast Induced Nephropathy (NEW-MOON)

University of Roma La Sapienza

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Intensive treatment with sodium bicarbonate; Drug: Standard treatment with saline infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01491243

652/2011/D

Details and patient eligibility

About

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

Full description

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

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Intensive treatment group

Active Comparator group

Description:

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

Treatment:

Drug: Intensive treatment with sodium bicarbonate

Standard treament group

Active Comparator group

Description:

Patients will receive i.v. 1 ml/kg/h saline infusion for 48 h after PCI in case of abnormal NGAL findings

Treatment:

Drug: Standard treatment with saline infusion