Nephro Trial Files: Eculizumab vs. Placebo for STEC-HUS, Taurolidine/Heparin Lock Solution for Reducing CRBSI in Hemodialysis, and Glutamine for AKI After Cardiac Surgery
Efficacy and Safety of Eculizumab in Pediatric Patients Affected by Shiga Toxin–Related Hemolytic and Uremic Syndrome
Garnier A et al. JASN (September 2023)
Bottom Line: This Phase 3 randomized, placebo-controlled trial included 100 pediatric patients with Shiga toxin-related hemolytic uremic syndrome (STEC-HUS). Patients were randomly assigned in a 1:1 ratio to receive either eculizumab or placebo during 4 weeks, with follow-up lasting for 1 year. The primary end point was renal replacement therapy (RRT) duration <48 hours after randomization. Results showed no significant difference between the two groups (48% in the placebo versus 38% in the eculizumab group; P = 0.31). However, the proportion of patients experiencing renal sequelae at 1 year was lower in the eculizumab group than in the placebo group (43.48% and 64.44%, respectively, P = 0.04). No safety concerns were reported.
Taurolidine/Heparin Lock Solution and Catheter-Related Bloodstream Infection in Hemodialysis
Agarwal AK et al. CJASN (November 2023)
Bottom Line: The LOCK IT-100 trial was a randomized, double-blind, active-control, multicenter, phase 3 study that enrolled 795 adults with kidney failure undergoing maintenance hemodialysis via CVC from 70 US sites. Participants were randomized 1:1 to taurolidine/heparin catheter lock solution or heparin control catheter lock solution (1000 units/ml). The primary end point was time to CRBSI as assessed by a blinded Clinical Adjudication Committee. Results showed that event rates per 1000 catheter days were 0.13 and 0.46, respectively, with the difference in time to CRBSI being statistically significant, favoring taurolidine/heparin (P < 0.001). The hazard ratio was 0.29 (95% confidence interval, 0.14 to 0.62), corresponding to a 71% reduction in risk of CRBSIs with taurolidine/heparin versus heparin. The safety of taurolidine/heparin was comparable with that of heparin, and most treatment-emergent adverse events were mild or moderate. This study concluded that taurolidine/heparin reduced the risk of developing a CRBSI in study participants receiving hemodialysis via CVC compared with heparin with a comparable safety profile.
Effect of Glutamine Administration After Cardiac Surgery on Kidney Damage in Patients at High Risk for Acute Kidney Injury
Weiss R et al. Anesthesia & Analgesia (November 2023)
Bottom Line: This randomized, double-blind pilot study included 64 eligible cardiac surgery patients at high risk for AKI. Patients were randomized to receive body weight-adapted intravenous glutamine or saline-control for 12 hours postoperatively. The primary outcome was urinary [TIMP2]*[IGFBP7] at the end of the 12-hour study period. Results showed that glutamine significantly decreased markers of kidney damage compared to the control group. Secondary outcomes included kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL) at 12 hours, overall AKI rates at 72 hours, free days through day 28 of mechanical ventilation and vasoactive medication, renal recovery at day 90, requirement of renal replacement therapy and mortality each at days 30, 60, and 90, length of intensive care unit (ICU) and hospital stay, and major adverse kidney events at day 90. The conclusion was that glutamine may be able to reduce the occurrence of AKI after cardiac surgery.
Nephro Trial Files Issue #NPH-2024-02
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