N-GAL Allows Intensive Treatment of Contrast Induced Nephropathy
NCT ID: NCT01491243
Last Updated: 2013-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2014-01-31
2017-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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
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 treament group
Patients will receive i.v. 1 ml/kg/h saline infusion for 48 h after PCI 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Francesco Pelliccia
Assistant Professor
Locations
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University La Sapienza
Rome, , Italy
Countries
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Central Contacts
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Other Identifiers
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652/2011/D
Identifier Type: -
Identifier Source: org_study_id
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