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Kidney Week

Abstract: TH-PO1184

Double vs. Single Icodextrin Dose in Older Incident Patients on Incremental Continuous Ambulatory Peritoneal Dialysis (CAPD): Results from the DIDo (Double Icodextrin Dose) Study

Session Information

Category: Dialysis

  • 802 Dialysis: Home Dialysis and Peritoneal Dialysis

Authors

  • Goffin, Eric, Cliniques universitaires Saint-Luc, Bruxelles, Belgium
  • Béchade, Clémence, CHU Clemenceau, Caen, Basse-Normandie, France
  • Courivaud, Cécile, Centre Hospitalier Universitaire de Besancon, Besancon, Bourgogne-Franche-Comté, France
  • Francois, Karlien, Vrije Universiteit Brussel, Brussel, Belgium
  • Bammens, Bert, Katholieke Universiteit Leuven, Leuven, Flanders, Belgium
  • Jadoul, Michel Y., Cliniques universitaires Saint-Luc, Bruxelles, Belgium
  • Devuyst, Olivier, Cliniques universitaires Saint-Luc, Bruxelles, Belgium
  • Wilkie, Martin E., Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom
  • Bertrand, Aurélie, Universite catholique de Louvain, Louvain-la-Neuve, Walloon Brabant , Belgium
  • Lobbedez, Thierry, CHU Clemenceau, Caen, Basse-Normandie, France

Group or Team Name

  • DIDo Study Group.
Background

Icodextrin, a high MW glucose polymer, provides sustained ultrafiltration (UF) in PD patients through colloid osmosis, leading to improved clinical outcomes. Icodextrin is limited to one bag/day. Improved UF and technical survival have been observed with an off-label use of two bags/day.

Methods

DIDo is a prospective, international, 1:1 randomized controlled trial. It investigates superiority and safety of using two vs one icodextrin bag/day to extend the duration of incremental (3 bags/day) CAPD in older (> 60 yrs) incident patients. After a 2-months run-in period, patients were randomized to two icodextrin + one glucose (group A) or one icodextrin + two glucose - the reference treatment - (group B) daily. Hypothesis was that group A would remain longer on 3 exchanges/day. Primary outcome was a composite of excessive predefined hypertonic dialysates use, transfer to another dialysis modality or death at M9. Secondary outcomes included mortality, daily UF, technique survival, and rates of peritonitis and hospitalizations at M18. SAEs and side-effects potentially related to icodextrin (low serum sodium, hypotension, skin rash and sterile peritonitis) were assessed.

Results

41 patients were randomized to group A and 42 to group B. Baseline characteristics (demographics, comorbidities, lab and CAPD parameters, and medications), were well balanced between groups. Median FU was 31 months. At M9, the proportion of patients who discontinued 3 exchanges/day was similar between group A and B [16 (39%) vs. 21 (50%)]. There were no differences between both arms in any primary outcome component, nor significant interaction with clinical characteristics. The results were similar at M18 [(24 (59%) vs. 24 (57%)]. Patients in group A had significantly higher (>400 mL) daily net UF at all time points. Rates of peritonitis, hospitalizations, residual urine output and all AEs were similar between groups.

Conclusion

In older patients on incremental CAPD, a double icodextrin dose initiated at PD onset did not reduce the cumulative incidence of the composite primary outcome compared to a single icodextrin dose. Significantly enhanced UF was observed in patients receiving the double icodextrin dose while no safety issues were observed.

Funding

  • Commercial Support – Baxter Healthcare