N-GAL Allows Intensive Treatment of Contrast Induced Nephropathy

NCT01491243 | Unknown Phase 4

• 1 other identifier: 652/2011/D
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease

Keywords

contrast-induced nephropathy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Post-angiographic changes in renal function parameters

  Baseline and 48 hours after angiography

Study Arms (2)

Intensive treatment group

ACTIVE COMPARATOR

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

Standard treament group

ACTIVE COMPARATOR

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

Interventions

Intensive treatment with sodium bicarbonate DRUG

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

Intensive treatment group

Standard treatment with saline infusion DRUG

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

Standard treament group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

University La Sapienza

Rome, 00166, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Francesco Pelliccia, MD

CONTACT

+393483392006; f.pelliccia@mclink.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 11, 2011
• First Posted: December 13, 2011
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2017
• Last Updated: March 7, 2013

Record last verified: 2013-03

Locations

IT (1)