23 Randomised trial comparing one-hour sodium bicarbonate hydration prior to CT scan versus standard periprocedural saline hydration among patients with chronic kidney disease - The Saliña Trial
Kooiman, J, Sijpkens, Y.W.J., Vries, J.P.P.M. de, Brulez, H.F.H., Hamming, J.F., Molen, A.J. van der, Aarts, N.J.M., Cannegieter, S.C., Putter, H., Swarts, R., Hout, W.B. van den, Rabelink, T.J., Huisman, M.V.
Locatie(s): Zaal 0.5
Categorie(ën): Parallelsessie
Background: Yearly, 380,000 and 130,000 patients with chronic kidney disease (CKD) in the United Kingdom and the Netherlands, respectively, undergo intravenous contrast-media enhanced CT (CE-CT), requiring hospitalization for hydration to prevent contrast media induced-acute kidney injury (CI-AKI). We analysed whether one hour sodium bicarbonate hydration prior to CE-CT is non-inferior to standard saline hydration prior to and after CE-CT in CKD patients.
Methods: In this multicentre open-label randomized trial, CKD (estimated glomerular filtration rate < 60 ml/min) patients were randomized using a computer-generated allocation sequence (1:1) to 250 ml 1.4% sodium bicarbonate hydration prior to CE-CT or 1000 ml 0.9% saline hydration prior to and after CE-CT. Primary outcome was the relative increase in serum creatinine 48-96 hours post CE-CT. Secondary outcomes were: incidence of CI-AKI (serum creatinine increase > 25%/> 44 µmol/L), recovery of renal function, the need for dialysis, and 2-month hospital costs. The study was analysed blinded to group assignment and registered at www.trialregister.nl, number NTR2149.
Results: 570 patients were randomized; 22 withdrew informed consent. The intention-to-treat population included 267 patients randomized to sodium bicarbonate and 281 to saline. Mean relative serum creatinine increase was 1·2% for sodium bicarbonate and 1·5% for saline (mean difference -0.3%; 95% CI -2.7-2.1, P-value for non-inferiority < 0.0001). CI-AKI occurred in 22 patients (4.1%); 8 (3.0%) randomized to sodium bicarbonate versus 14 (5.1%) to saline (p = 0.23). Renal function recovered in 75% and 69% of CI-AKI patients, respectively (p = 0.81). No patient developed a need for dialysis. Mean costs per patient were € 224 for the sodium bicarbonate and € 683 for the saline regime (p < 0.001). Other health care costs were similar.
Interpretation: Sodium bicarbonate hydration prior to CE-CT is equally effective as periprocedural saline hydration and significantly reduces hydration costs. Therefore, sodium bicarbonate hydration is the preferred method for preventive hydration in CKD patients undergoing CE-CT.
- Over Kooiman, J
- Over Sijpkens, Y.W.J.
- Over Vries, J.P.P.M. de
- Over Brulez, H.F.H.
- Over Hamming, J.F.
- Over Molen, A.J. van der
- Over Aarts, N.J.M.
- Over Cannegieter, S.C.
- Over Putter, H.
- Over Swarts, R.
- Over Hout, W.B. van den
- Over Rabelink, T.J.
- Over Huisman, M.V.