Bicarbonate pre hydration before contrast CT may not confer renal safety in CKD: JAMA
Netherlands: Withholding short bicarbonate prehydration in patients with stage 3 chronic kidney disease (CKD) undergoing contrast-enhanced computed tomography does not compromise renal safety, according to findings from the Kompas trial.
Findings, published in the journal JAMA Internal Medicine, suggests that it is safe to omit pre hydration with 1-hour sodium bicarbonate infusion in patients with stage 3 CKD undergoing elective contrast-enhanced computed tomography.
Prevention of postcontrast acute kidney injury in patients with stage 3 CKD by means of prehydration has been standard care for years. However, evidence for the need for prehydration in this group is limited. Rohit J. Timal, Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands, and colleagues aimed to assess the renal safety of omitting prophylactic prehydration prior to iodine-based contrast media administration in patients with stage 3 CKD.
The Kompas trial was a multicenter, noninferiority, randomized clinical trial conducted at 6 hospitals in the Netherlands. In the trial, 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. The final follow-up was completed in September 2017. Data were analyzed from January 2018 to June 2019.
In total, 262 patients were allocated to the no prehydration group and 261 were allocated to receive prehydration. Analysis on the primary endpoint was available in 505 patients (96.6%).
The primary endpoint 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.
Key findings of the study include:
- 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).
- 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.
- 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.
- Other health care costs were similar.
"The findings of this study support the option of not giving prehydration as a safe and cost-efficient measure" concluded the authors.
The study, "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," is published in the journal JAMA Internal Medicine.