PrevenTion of Contrast-inducEd nephroAThy With urinE Alkalinization

• Status: Completed
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Intravascular administration of iodinated contrast media is an essential tool for cardiovascular imaging and percutaneous coronary interventions. Nonetheless, the increasing incidence of contrast-induced nephropathy (CIN) has become an important and prognostically relevant problem along with the spreading of diagnostic and interventional procedures. CIN is largely dependent on oxidative damage and represents a considerable cause of renal failure, being associated with prolonged hospitalization and significant morbidity/mortality. The most effective treatment strategy of this serious complication remains prevention, and several preventive measures have been extensively investigated in the last few years. Pre-procedural hydration is the best known and mostly accepted strategy. The administration of sodium bicarbonate (HCO3) has controversial effects, and is likely to be ineffective when the infused dose is unable to achieve adequate urine alkalinization. Since alkaline pH suppresses the production of free radicals, increasing urine pH would be an attractive goal for CIN prevention. In a randomized clinical trial the investigators will test the hypothesis that urine alkalinization with either oral or i.v. bicarbonate on top of hydration alone is the main determinant of CIN prevention in a population of patients with moderate or severe chronic kidney disease scheduled for coronary angiography and/or angioplasty. If the investigators, demonstrate non-significant differences in urine alkalinization (primary endpoint) and incidence of CIN (secondary endpoint) between the bicarbonate groups, a practical implication will be that oral administration is preferable for practical reasons over the administration of i.v. bicarbonate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: G. d'Annunzio University

Criteria

Inclusion Criteria:

• Consecutive patients scheduled for coronary angiography and/or angioplasty;

• eGFR <60 mL/min/1.73 m2, but >15 mL/min/1.73 m2 (MDRD formula).

Exclusion Criteria:

• acute renal insufficiency;

• emergency catheterization (e.g., STEMI patients) preventing the possibility of pretreatments;

• a history of adverse reactions to contrast media;

• use of potentially nephrotoxic drugs (non-steroidal anti-inflammatory drugs, aminoglycosides, sulphonamides, cyclosporin, tacrolimus, methotrexate or platinum complexes) from 48 hours before to 24 hours after the procedure, but allowing drugs deemed essential for cardiovascular therapy (diuretics, acetylsalicylic acid, angiotensinconverting enzyme inhibitors, angiotensin receptor blockers or aliskiren);

• pulmonary edema;

• multiple myeloma and other monoclonal gammopathies;

• factors predisposing to kidney injury: diarrhea, vomiting, dehydration or bleeding;

• exposure to contrast media within 7 days before the procedure; pregnancy; -

• hypersensitivity to the active substance or to any of the excipients;

• Metabolic or respiratory alkalosis, particularly if hypochloremic (vomiting, gastrointestinal losses, diuretic therapy);

• Hypocalcemia;

• use of N-acetyl cysteine, theophylline, dopamine, fenoldopam, mannitol, citrate or bicarbonate within 48 hours before coronary angiography;

• Chronic and / or acute therapy with corticosteroid, quinidine, ephedrine and pseudoephedrine;

• urinary tract infections.