N-GAL Allows Intensive Treatment of Contrast Induced Nephropathy

Coronary Artery Disease Clinical Trial

— NEW-MOON  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01491243
• Other study ID #: 652/2011/D
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 11, 2011
• Last updated: March 6, 2013
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2013
• Source: University of Roma La Sapienza
• Contact: Francesco Pelliccia, MD
• Phone: +393483392006
• Email: f.pelliccia[@]mclink.it
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Kidney Diseases
• Myocardial Ischemia

Intervention

Drug:
• Intensive 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
• Standard treatment with saline infusion
i.v. 1 ml/kg/h saline infusion for 48 h in case of abnormal NGAL findings

Locations

Country	Name	City	State
Italy	University La Sapienza	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No