Nephro Trial Files: Plasma-Lyte-148 vs. Standard IV Fluids in Pediatric Kidney Transplants, Dialysate Sodium Lowering, and Prednisolone vs. Levamisole in Relapsing Nephrotic Syndrome
A pragmatic, open-label, randomized controlled trial of Plasma-Lyte-148 versus standard intravenous fluids in children receiving kidney transplants (PLUTO)
Hayes WN et al. Kidney International (February 2024)
Bottom Line: This is a pragmatic, open-label, randomized controlled trial with a sample size of 137 pediatric kidney transplant recipients. The study compared the effects of Plasma-Lyte-148 and standard perioperative intravenous fluids on acute electrolyte and acid-base abnormalities in the first 72 hours post-transplant. The primary outcome, acute hyponatremia, was experienced by 53% of participants in the Plasma-Lyte-148 group and 58% in the standard fluids group. However, there were fewer changes to fluid prescriptions and a lower incidence of hyperchloremia and acidosis in the Plasma-Lyte-148 group. Serious adverse events were reported in 9% of participants in the Plasma-Lyte-148 group and 7% in the standard fluids group. The study concluded that Plasma-Lyte-148 did not significantly decrease the incidence of acute hyponatremia but had some benefits in terms of fluid prescription changes and electrolyte abnormalities.
Dialysate Sodium Lowering in Maintenance Hemodialysis
Miskulin DC et al. CJASN (February 2024)
Bottom Line: This randomized clinical trial, conducted over a period of 6 months with a 12-week extension, aimed to evaluate the effects of lowering dialysate sodium from 138 to 135 mEq/L in maintenance hemodialysis patients. The study included 42 participants, with 2:1 randomization to the intervention (135 mEq/L) and comparator (138 mEq/L) groups. The primary outcome was intradialytic hypotension (IDH), with secondary outcomes including dialysis disequilibrium symptoms, ER visits/hospitalizations, interdialytic weight gain, and blood pressure (BP). Results showed no significant difference in IDH or ER visits/hospitalizations between the two groups, but a small reduction in interdialytic weight gain and an increase in symptoms in the intervention group. Raising dialysate sodium from 135 to 140 mEq/L was associated with a reduction in IDH, a small increase in interdialytic weight gain, and a marked increase in predialysis BP. The study concluded that lowering dialysate sodium may not significantly impact IDH or predialysis BP, but may result in a decrease in interdialytic weight gain and an increase in symptoms. However, raising dialysate sodium may lead to a reduction in IDH, but also an increase in interdialytic weight gain and predialysis BP.
An open label non-inferiority randomized control trial evaluated alternate day prednisolone given daily during infections vs. levamisole in frequently relapsing nephrotic syndrome
Sinha A et al. Kidney International (February 2024)
Bottom Line: This is an open label, non-inferiority trial with a duration of one year, including 160 patients aged 2-18 years with frequent relapses of nephrotic syndrome. The intervention group received prednisolone (0.5-0.7 mg/kg/alternate-day, given daily during infections) and the comparator group received levamisole (2-2.5 mg/kg/alternate-days). The primary outcome was the proportion of patients with frequent relapses, and the results showed that levamisole was more effective in preventing frequent relapses compared to prednisolone. Both therapies showed similar rates of sustained remission and relapses, with low rates of adverse events. Levamisole was also found to be relatively steroid-sparing. This study suggests that levamisole may be a preferred therapy for frequently relapsing nephrotic syndrome, especially in patients at risk of steroid toxicity.
Nephro Trial Files Issue #NPH-2024-06
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