N-GAL Allows Intensive Treatment of Contrast Induced Nephropathy (NEW-MOON)
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|ClinicalTrials.gov Identifier: NCT01491243|
Recruitment Status : Unknown
Verified March 2013 by Francesco Pelliccia, University of Roma La Sapienza.
Recruitment status was: Not yet recruiting
First Posted : December 13, 2011
Last Update Posted : March 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Intensive treatment with sodium bicarbonate Drug: Standard treatment with saline infusion||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Neutrophil gElatinase-associated Lipocalin alloWs Intensive treatMent Of cOntrast Induced Nephropathy in Patients With Urgent/Emergency Percutaneous Coronary Intervention|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2017|
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
- Incidence of contrast induced nephropathy [ Time Frame: Baseline and 48 hours after angiography ]Absolute increase in serum creatinine equal to or greater than 0.5 mg/dL detected 48 hours after angiography as compared with baseline value
- Post-angiographic changes in renal function parameters [ Time Frame: Baseline and 48 hours after angiography ]Changes in creatinine levels and estimated glomerular filtration rate at 48-hour evaluation after angiography as compared with baseline values
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491243
|Contact: Francesco Pelliccia, MDemail@example.com|
|University La Sapienza|
|Rome, Italy, 00166|