H0= Saline is inferior to sodium bicarbonate for the prevention of contrast induced nephropathy in patients undergoing computed tomography after intravenous contrast administration. H1= Saline is noninferior to sodium bicarbonate for the prevention…
ID
Bron
Verkorte titel
Aandoening
Prevention, Contrast Induced Nephropathy, Computed Tomography, hydration
preventie, contrastnefropathie, CT-scan, hydratie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Mean increase in serum creatinine 2-4 days after contrast administration.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
H0= Saline is inferior to sodium bicarbonate for the prevention of contrast induced nephropathy in patients undergoing computed tomography after intravenous contrast administration.
H1= Saline is noninferior to sodium bicarbonate for the prevention of contrast induced nephropathy in patients undergoing computed tomography after intravenous contrast administration.
Onderzoeksopzet
1. 4 hours after computed tomography;
2. 3 (+/- 1 day) after computed tomography;
3. 2 months after computed tomography when contrast induced nephropathy is diagnosed after 3 days (2).
Onderzoeksproduct en/of interventie
Group 1: Sodium Bicarbonate 1.4% 1 hour prior to computed tomography 250 mL. No posthydration.
Group 2: Sodium Chloride 0.9% 1 ml/hr/kg bodyweight, during 12 hours for and after computed tomography.
Publiek
Judith Kooiman
Leiden University Medical Center, Albinusdreef 2, Postzone C4-70
Leiden 2333 ZA
The Netherlands
+31 (0)71-526.20.85
j.kooiman@lumc.nl
Wetenschappelijk
Judith Kooiman
Leiden University Medical Center, Albinusdreef 2, Postzone C4-70
Leiden 2333 ZA
The Netherlands
+31 (0)71-526.20.85
j.kooiman@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. eGFR < 45 ml/min/1.73m2;
2. eGFR < 60 ml/min/1.73m2 and diabetes mellitus.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Age < 18 years;
2. Exposure to radiographic contrast media within 7 days;
3. Pregnancy;
4. Allergy for low osmolar contrast media.
Opzet
Deelname
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