Sodium Bicarbonate for the prevention of Contrast Induced Nephropathy in patients undergoing CTPA

INTERVENTION: Trade Name: Natriumwaterstofcarbonaat 1,4% Product Name: Natriumwaterstofcarbonaat Product Code: N.A. Pharmaceutical Form: Solution for infusion CAS Number: 0 Other descriptive name: SODIUM HYDROGEN CARBONATE Concentration unit: % percent Concentration type: equal Concentration number: 1.4‐ CONDITION: The prevention of Contrast Induced Nephropathy is under investigation. Contrast induced nephropathy (CIN) can occur after injecting radiographic iso osmolair contrast media. Patients with a renal impairment or a decreased renal function and aspecially in combination with diabetis mellitus are at risk for developing CIN. ; MedDRA version: 12.0 Level: LLT Classification code 10037790 Term: Radiocontrast nephropathy PRIMARY OUTCOME: Main Objective: ‐Evaluation of the mean increase in serum creatinine following CTPA (CT‐ pulmonary angiography) without prehydration compaired to a short prehydration regime with sodium bicarbonate during one hour. Primary end point(s): ‐ Mean increase in serum creatinine 2‐4 days after CTPA Secondary Objective: ‐Evaluation of the incidence of CIN following CTPA without prehydration compaired to a short prehydration regime with sodium bicarbonate during one hour.; ‐Furthermore, the risk of developing CIN after CTPA with iso‐osmolair contrast media is studied for both patient groups INCLUSION CRITERIA: ‐estimated glomerular filtration rate (eGFR) < 60 ml/min ‐ clinical suspected acute pulmonary embolism with an indication for CTPA with intravenous administration of iso osmolar contrast media. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range