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Original Investigation
February 17, 2020

Effect of No Prehydration vs Sodium Bicarbonate Prehydration Prior to Contrast-Enhanced Computed Tomography in the Prevention of Postcontrast Acute Kidney Injury in Adults With Chronic Kidney Disease: The Kompas Randomized Clinical Trial

Author Affiliations
  • 1Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands
  • 2Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands
  • 3Department of Obstetrics and Gynaecology, Utrecht University Medical Center, Utrecht, the Netherlands
  • 4Department of Internal Medicine, Haaglanden Medisch Centrum Bronovo, The Hague, the Netherlands
  • 5Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, the Netherlands
  • 6Department of Vascular Surgery, University Medical Centre Groningen, Groningen, the Netherlands
  • 7Department of Internal Medicine, Maasstad Hospital, Rotterdam, the Netherlands
  • 8Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands
  • 9Department of Internal Medicine, Haga Teaching Hospital, The Hague, the Netherlands
  • 10Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands
  • 11Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands
  • 12Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands
  • 13Department of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands
JAMA Intern Med. 2020;180(4):533-541. doi:10.1001/jamainternmed.2019.7428
Key Points

Question  Is it safe to omit prehydration with 1-hour sodium bicarbonate infusion in patients with stage 3 chronic kidney disease undergoing elective contrast-enhanced computed tomography?

Findings  In this noninferiority randomized clinical trial that included 523 adults with stage 3 chronic kidney disease, the mean relative increase in serum creatinine level 2 to 5 days after intravenous contrast media administration compared with baseline was 3.0% in the no prehydration group vs 3.5% in the bicarbonate prehydration group.

Meaning  Withholding short bicarbonate prehydration does not compromise renal safety in patients with stage 3 chronic kidney disease undergoing contrast-enhanced computed tomography.

Abstract

Importance  Prevention of postcontrast acute kidney injury in patients with stage 3 chronic kidney disease (CKD) by means of prehydration has been standard care for years. However, evidence for the need for prehydration in this group is limited.

Objective  To assess the renal safety of omitting prophylactic prehydration prior to iodine-based contrast media administration in patients with stage 3 CKD.

Design, Setting, and Participants  The Kompas trial was a multicenter, noninferiority, randomized clinical trial conducted at 6 hospitals in the Netherlands in which 523 patients with stage 3 CKD were randomized in a 1:1 ratio to receive no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate administered in a 1-hour infusion before undergoing elective contrast-enhanced computed tomography from April 2013 through September 2016. Final follow-up was completed in September 2017. Data were analyzed from January 2018 to June 2019.

Interventions  In total, 262 patients were allocated to the no prehydration group and 261 were allocated to receive prehydration. Analysis on the primary end point was available in 505 patients (96.6%).

Main Outcomes and Measures  The primary end point was the mean relative increase in serum creatinine level 2 to 5 days after contrast administration compared with baseline (noninferiority margin of less than 10% increase in serum creatinine level). Secondary outcomes included the incidence of postcontrast acute kidney injury 2 to 5 days after contrast administration, mean relative increase in creatinine level 7 to 14 days after contrast administration, incidences of acute heart failure and renal failure requiring dialysis, and health care costs.

Results  Of 554 patients randomized, 523 were included in the intention-to-treat analysis. The median (interquartile range) age was 74 (67-79) years; 336 (64.2%) were men and 187 (35.8%) were women. The mean (SD) relative increase in creatinine level 2 to 5 days after contrast administration compared with baseline was 3.0% (10.5) in the no prehydration group vs 3.5% (10.3) in the prehydration group (mean difference, 0.5; 95% CI, −1.3 to 2.3; P < .001 for noninferiority). Postcontrast acute kidney injury occurred in 11 patients (2.1%), including 7 of 262 (2.7%) in the no prehydration group and 4 of 261 (1.5%) in the prehydration group, which resulted in a relative risk of 1.7 (95% CI, 0.5-5.9; P = .36). None of the patients required dialysis or developed acute heart failure. Subgroup analyses showed no evidence of statistical interactions between treatment arms and predefined subgroups. Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001). Other health care costs were similar.

Conclusions and Relevance  Among patients with stage 3 CKD undergoing contrast-enhanced computed tomography, withholding prehydration did not compromise patient safety. The findings of this study support the option of not giving prehydration as a safe and cost-efficient measure.

Trial Registration  Netherlands Trial Register Identifier: NTR3764

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