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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Intensive treatment with sodium bicarbonate
Standard treatment with saline infusion
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring contrast-induced nephropathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University La Sapienza

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intensive treatment group

Standard treament group

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 11, 2011
Last Updated
March 6, 2013
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT01491243
Brief Title
N-GAL Allows Intensive Treatment of Contrast Induced Nephropathy
Acronym
NEW-MOON
Official Title
Neutrophil gElatinase-associated Lipocalin alloWs Intensive treatMent Of cOntrast Induced Nephropathy in Patients With Urgent/Emergency Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
contrast-induced nephropathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive treatment group
Arm Type
Active Comparator
Arm 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
Arm Title
Standard treament group
Arm Type
Active Comparator
Arm Description
Patients will receive i.v. 1 ml/kg/h saline infusion for 48 h after PCI in case of abnormal NGAL findings
Intervention Type
Drug
Intervention Name(s)
Intensive treatment with sodium bicarbonate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Standard treatment with saline infusion
Intervention Description
i.v. 1 ml/kg/h saline infusion for 48 h in case of abnormal NGAL findings
Primary Outcome Measure Information:
Title
Incidence of contrast induced nephropathy
Description
Absolute increase in serum creatinine equal to or greater than 0.5 mg/dL detected 48 hours after angiography as compared with baseline value
Time Frame
Baseline and 48 hours after angiography
Secondary Outcome Measure Information:
Title
Post-angiographic changes in renal function parameters
Description
Changes in creatinine levels and estimated glomerular filtration rate at 48-hour evaluation after angiography as compared with baseline values
Time Frame
Baseline and 48 hours after angiography

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Pelliccia, MD
Phone
+393483392006
Email
f.pelliccia@mclink.it
Facility Information:
Facility Name
University La Sapienza
City
Rome
ZIP/Postal Code
00166
Country
Italy

12. IPD Sharing Statement

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N-GAL Allows Intensive Treatment of Contrast Induced Nephropathy

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