N-GAL Allows Intensive Treatment of Contrast Induced Nephropathy

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01491243

Acronym

NEW-MOON

Enrollment

100

Registered

2011-12-13

Start date

2014-01-31

Completion date

2017-12-31

Last updated

2013-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

contrast-induced nephropathy

Brief summary

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

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

Interventions

DRUGIntensive treatment with sodium bicarbonate

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

DRUGStandard treatment with saline infusion

i.v. 1 ml/kg/h saline infusion for 48 h in case of abnormal NGAL findings

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Contacts

Primary ContactFrancesco Pelliccia, MD

f.pelliccia@mclink.it+393483392006

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026