Background Low-intensity shockwave therapy (LI-SWT) is suggested as a therapy for promoting tissue regeneration. In pigs, it was recently found that LI-SWT improved renal function after ischaemic injury. Our objectives were to study glomerular filtration rate (GFR) and albuminuria in diabetic nephropathy (DN) after treatment with LI-SWT. The present pilot study reports on the clinical safety of LI-SWT in DN. Methods A total of 14 patients with diabetes mellitus and Stage 3 chronic kidney disease were recruited for this prospective, one-arm Phase 1 study. The patients were treated with six sessions of LI-SWT during a 3-week period. At each session, 3000 shockwaves were applied to each kidney with 0.265 mJ/mm2, extended focal size and 4 Hz. Follow-up visits were performed at 1, 3 and 6 months. Results In general, the treatment was well tolerated. Transient macroscopic haematuria was observed in three patients immediately after LI-SWT. The majority of patients experienced lower back tenderness lasting up to 2 days after treatment. There was no need for analgesic treatment. LI-SWT showed no negative effect on GFR and albuminuria. At baseline, median (interquartile range) GFR was 33.5 mL/min/1.73 m2 (27.8–43.8) compared with 36.0 mL/min/1.73 m2 (27.5–52.0) at 6 months follow-up. In parallel, median albuminuria was 256 mg/24 h (79–619) at baseline and tended to decrease to 137 mg/24 h (41–404) 6 months after LI-SWT. There was no statistical difference between baseline and follow-up results. Conclusions LI-SWT is a safe treatment for DN. Inclusion of more patients is needed to determine whether LI-SWT can improve renal functional outcomes.
Introduction There is a substantial risk of developing stenosis and dysfunction in the arteriovenous fistula (AVF) in patients on hemodialysis. Far infrared radiation (FIR) is a non-invasive local intervention with a potentially beneficial effect on AVF patency. The underlying mechanism is not clear. It was hypothesized that a single FIR treatment reduces factors of inflammation and promotes endothelial vasodilators in the AVF. Methods Forty hemodialysis patients with an AVF were included in an open-label intervention study.. Patients were randomized to receive either FIR (FIR group) or no FIR (control group). Blood samples were drawn directly from the AVF and from a peripheral vein in the non-AVF arm before (T0 minutes) and after (T40 minutes) treatment during a hemodialysis session. The changes (median [interquartile range]) in circulating factors of inflammation, endothelial function and vasoreactivity during FIR were measured. Results In the AVF a single FIR treatment during dialysis resulted in a significantly diminished decrease in soluble vascular cell adhesion molecule, sVCAM (−31.6 [−54.3;22.1] vs. −89.9 [−121.6; −29.3], P = 0.005) and soluble intercellular adhesion molecule, sICAM (−24.2 [−43.5;25.3] vs. −49 [−79.9; −11.6], P = 0.02) compared to the control group. Other factors, such as interleukins, nitrite, nitrate, and tumor-necrosis-factor 1 also declined during dialysis, but with no significant differences related to FIR in neither the AVF nor non-AVF arm. Conclusion A single FIR treatment attenuated the decrease in sVCAM and sICAM in the AVF compared to a control group during hemodialysis. Findings do not support the hypothesis of a vaso-protective effect of FIR. The long-term effects of FIR on the AVF are unknown.
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