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

This study is not yet open for participant recruitment.

Verified March 2013 by University of Roma La Sapienza

Sponsor:

Information provided by (Responsible Party):

Francesco Pelliccia, University of Roma La Sapienza

ClinicalTrials.gov Identifier:

NCT01491243

First received: December 11, 2011

Last updated: March 6, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 11, 2011

Last Updated Date

March 6, 2013

Start Date ^ICMJE

January 2014

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of contrast induced nephropathy [ Time Frame: Baseline and 48 hours after angiography ] [ Designated as safety issue: No ]

Absolute increase in serum creatinine equal to or greater than 0.5 mg/dL detected 48 hours after angiography as compared with baseline value

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01491243 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Post-angiographic changes in renal function parameters [ Time Frame: Baseline and 48 hours after angiography ] [ Designated as safety issue: No ]

Changes in creatinine levels and estimated glomerular filtration rate at 48-hour evaluation after angiography as compared with baseline values

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

N-GAL Allows Intensive Treatment of Contrast Induced Nephropathy

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Intensive treatment group
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

Intervention: Drug: Intensive treatment with sodium bicarbonate
Active Comparator: Standard treament group
Patients will receive i.v. 1 ml/kg/h saline infusion for 48 h after PCI in case of abnormal NGAL findings

Intervention: Drug: Standard treatment with saline infusion

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

December 2017

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Francesco Pelliccia, MD

+393483392006

f.pelliccia@mclink.it

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01491243

Other Study ID Numbers ^ICMJE

652/2011/D

Has Data Monitoring Committee

Responsible Party

Francesco Pelliccia, University of Roma La Sapienza

Study Sponsor ^ICMJE

University of Roma La Sapienza

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

University of Roma La Sapienza

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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