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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
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
 Drug: Intensive treatment with sodium bicarbonate
Drug: Standard treatment with saline infusion
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Neutrophil gElatinase-associated Lipocalin alloWs Intensive treatMent Of cOntrast Induced Nephropathy in Patients With Urgent/Emergency Percutaneous Coronary Intervention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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
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
 Drug: Standard treatment with saline infusion
i.v. 1 ml/kg/h saline infusion for 48 h in case of abnormal NGAL findings

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491243

Contacts
Contact: Francesco Pelliccia, MD +393483392006 f.pelliccia@mclink.it

Locations
Italy
University La Sapienza
Rome, Italy, 00166
Sponsors and Collaborators
University of Roma La Sapienza
  More Information

No publications provided

Responsible Party: Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01491243     History of Changes
Other Study ID Numbers: 652/2011/D
Study First Received: December 11, 2011
Last Updated: March 6, 2013
Health Authority: Italy: National Institute of Health

Keywords provided by University of Roma La Sapienza:
contrast-induced nephropathy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Kidney Diseases
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013