The Double-Icodextrin Dose Randomized Controlled Trial of a Double Icodextrin Dose for Older Patients on Incremental Continuous Ambulatory Peritoneal Dialysis
Introduction: Icodextrin enhances ultrafiltration (UF) in patients on peritoneal dialysis (PD) but is restricted to 1 bag/d, according to regulatory authorities. The Double-Icodextrin Dose (DIDo) study is a prospective randomized trial investigating the superiority and safety of using 2 bags/d versu...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-08-01
|
| Series: | Kidney International Reports |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2468024925003390 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849415460814061568 |
|---|---|
| author | Eric Goffin Clémence Béchade Cécile Courivaud Catherine Bresson Françoise Heibel Jean-Claude Stoléar Karlien François Fatouma Touré Didier Aguilera François Vrtovsnik Bert Bammens Michel Jadoul Olivier Devuyst Martin Wilkie Aurélie Bertrand Thierry Lobbedez Eric Goffin Bert Bammens Joelle Nortier Dr Philippe Bovy Dr Jean-Claude Stolear Karlien François Dr Olivier Mat François Vrtovsnik Dr Didier Aguilera Thierry Lobbedez Luc Frimat Dr Marie-Françoise Nogier Dr Alexandre Klein Cécile Courivaud Dr Marc Kribs Fatouma Touré Iain Macdougall Martin Wilkie |
| author_facet | Eric Goffin Clémence Béchade Cécile Courivaud Catherine Bresson Françoise Heibel Jean-Claude Stoléar Karlien François Fatouma Touré Didier Aguilera François Vrtovsnik Bert Bammens Michel Jadoul Olivier Devuyst Martin Wilkie Aurélie Bertrand Thierry Lobbedez Eric Goffin Bert Bammens Joelle Nortier Dr Philippe Bovy Dr Jean-Claude Stolear Karlien François Dr Olivier Mat François Vrtovsnik Dr Didier Aguilera Thierry Lobbedez Luc Frimat Dr Marie-Françoise Nogier Dr Alexandre Klein Cécile Courivaud Dr Marc Kribs Fatouma Touré Iain Macdougall Martin Wilkie |
| author_sort | Eric Goffin |
| collection | DOAJ |
| description | Introduction: Icodextrin enhances ultrafiltration (UF) in patients on peritoneal dialysis (PD) but is restricted to 1 bag/d, according to regulatory authorities. The Double-Icodextrin Dose (DIDo) study is a prospective randomized trial investigating the superiority and safety of using 2 bags/d versus 1 bag/d of icodextrin to extend incremental (3 bags/d) continuous ambulatory PD (CAPD) duration in older incident patients. Methods: After a 2-month “run-in” period, the patients were randomized to 2 icodextrin (“double dose”) + 1 glucose or 1 icodextrin (“single dose”) + 2 glucose dialysates daily. The primary end point was a composite of excessive use of hypertonic dialysates, transfer to another dialysis modality (automated PD [APD], nonincremental CAPD, or hemodialysis) or death at month 9. Secondary end points included mortality, daily UF, technique survival, rates of peritonitis and hospitalizations, and safety at month 18. Results: Forty-one patients were randomized to double dose and 42 to single-dose icodextrin. Baseline characteristics were well-balanced between groups. At month 9, the proportion of patients who discontinued 3 exchanges/d was similar between those receiving the double and the single icodextrin dose (16 [39%] vs. 21 [50%]; HR: 0.69; 95% confidence interval: 0.35–1.33). The results were similar at month 18. Patients in the double dose icodextrin had higher net UF and less hypertonic dialysates use. Rates of peritonitis, hospitalizations, residual urine output decline and serious adverse events (SAEs) were similar between both groups. Conclusion: In older patients on incremental CAPD, the double icodextrin dose did not reduce the primary outcome incidence compared with the single icodextrin dose. Significantly enhanced UF was observed in the double icodextrin dose group and no safety issue was identified. |
| format | Article |
| id | doaj-art-b8f6107ff88d47f78e42fc62d0941c63 |
| institution | Kabale University |
| issn | 2468-0249 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Kidney International Reports |
| spelling | doaj-art-b8f6107ff88d47f78e42fc62d0941c632025-08-20T03:33:31ZengElsevierKidney International Reports2468-02492025-08-011082585259610.1016/j.ekir.2025.05.036The Double-Icodextrin Dose Randomized Controlled Trial of a Double Icodextrin Dose for Older Patients on Incremental Continuous Ambulatory Peritoneal DialysisEric Goffin0Clémence Béchade1Cécile Courivaud2Catherine Bresson3Françoise Heibel4Jean-Claude Stoléar5Karlien François6Fatouma Touré7Didier Aguilera8François Vrtovsnik9Bert Bammens10Michel Jadoul11Olivier Devuyst12Martin Wilkie13Aurélie Bertrand14Thierry Lobbedez15Eric GoffinBert BammensJoelle NortierDr Philippe BovyDr Jean-Claude StolearKarlien FrançoisDr Olivier MatFrançois VrtovsnikDr Didier AguileraThierry LobbedezLuc FrimatDr Marie-Françoise NogierDr Alexandre KleinCécile CourivaudDr Marc KribsFatouma TouréIain MacdougallMartin WilkieDepartment of Nephrology, Cliniques universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium; Correspondence: Eric Goffin, Department of Nephrology, Cliniques univesitaires Saint-LucAvenue Hippocrate 10, 1200 Brussels, Belgium.Department of Nephrology, Centre Universitaire des Maladies Rénales, UNICAEN, CHU de Caen Normandie, Normandie Université, Caen, France; UFR de Médecine, UNICAEN, Normandie Université, Caen, France; Anticipe, U1086 Inserm-UCN, Centre Hospitalier Universitaire de Caen, Caen, FranceDepartment of Nephrology, Centre Hospitalier Universitaire de Besançon, Besançon, FranceDepartment of Nephrology, Centre Hospitalier Universitaire de Besançon, Besançon, FranceDepartment of Nephrology, Hopital Civil, Strasbourg, FranceDepartment of Nephrology, Centre Hospitalier de Wallonie Picarde, Tournai, BelgiumDepartment of Nephrology and Arterial Hypertension, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium; Kidney Diseases, Dialysis and Transplantation Research Unit, Vitality Research Group, Vrije Universiteit Brussel, Brussels, BelgiumDepartment of Nephrology, Centre Hospitalier Universitaire Dupuytren, Limoges, FranceDepartment of Nephrology, Hôpital de Vichy, Vichy, FranceDepartment of Nephrology, Centre Hospitalier Universitaire Bichat, Paris, FranceDepartment of Microbiology, Immunology and Transplantation, Nephrology and Renal Transplantation Research Group, KU Leuven, Belgium; Department of Nephrology, Dialysis and Renal Transplantation, University Hospitals Leuven, Leuven, BelgiumDepartment of Nephrology, Cliniques universitaires Saint-Luc, Université catholique de Louvain, Brussels, BelgiumDepartment of Nephrology, Cliniques universitaires Saint-Luc, Université catholique de Louvain, Brussels, BelgiumSheffield Kidney Institute, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UKStatistical Methodology and Computing Service Technological Platform, UCLouvain, Ottignies-Louvain-la-Neuve, BelgiumDepartment of Nephrology, Centre Universitaire des Maladies Rénales, UNICAEN, CHU de Caen Normandie, Normandie Université, Caen, France; UFR de Médecine, UNICAEN, Normandie Université, Caen, France; Anticipe, U1086 Inserm-UCN, Centre Hospitalier Universitaire de Caen, Caen, FranceIntroduction: Icodextrin enhances ultrafiltration (UF) in patients on peritoneal dialysis (PD) but is restricted to 1 bag/d, according to regulatory authorities. The Double-Icodextrin Dose (DIDo) study is a prospective randomized trial investigating the superiority and safety of using 2 bags/d versus 1 bag/d of icodextrin to extend incremental (3 bags/d) continuous ambulatory PD (CAPD) duration in older incident patients. Methods: After a 2-month “run-in” period, the patients were randomized to 2 icodextrin (“double dose”) + 1 glucose or 1 icodextrin (“single dose”) + 2 glucose dialysates daily. The primary end point was a composite of excessive use of hypertonic dialysates, transfer to another dialysis modality (automated PD [APD], nonincremental CAPD, or hemodialysis) or death at month 9. Secondary end points included mortality, daily UF, technique survival, rates of peritonitis and hospitalizations, and safety at month 18. Results: Forty-one patients were randomized to double dose and 42 to single-dose icodextrin. Baseline characteristics were well-balanced between groups. At month 9, the proportion of patients who discontinued 3 exchanges/d was similar between those receiving the double and the single icodextrin dose (16 [39%] vs. 21 [50%]; HR: 0.69; 95% confidence interval: 0.35–1.33). The results were similar at month 18. Patients in the double dose icodextrin had higher net UF and less hypertonic dialysates use. Rates of peritonitis, hospitalizations, residual urine output decline and serious adverse events (SAEs) were similar between both groups. Conclusion: In older patients on incremental CAPD, the double icodextrin dose did not reduce the primary outcome incidence compared with the single icodextrin dose. Significantly enhanced UF was observed in the double icodextrin dose group and no safety issue was identified.http://www.sciencedirect.com/science/article/pii/S2468024925003390icodextrinperitoneal dialysisultrafiltration |
| spellingShingle | Eric Goffin Clémence Béchade Cécile Courivaud Catherine Bresson Françoise Heibel Jean-Claude Stoléar Karlien François Fatouma Touré Didier Aguilera François Vrtovsnik Bert Bammens Michel Jadoul Olivier Devuyst Martin Wilkie Aurélie Bertrand Thierry Lobbedez Eric Goffin Bert Bammens Joelle Nortier Dr Philippe Bovy Dr Jean-Claude Stolear Karlien François Dr Olivier Mat François Vrtovsnik Dr Didier Aguilera Thierry Lobbedez Luc Frimat Dr Marie-Françoise Nogier Dr Alexandre Klein Cécile Courivaud Dr Marc Kribs Fatouma Touré Iain Macdougall Martin Wilkie The Double-Icodextrin Dose Randomized Controlled Trial of a Double Icodextrin Dose for Older Patients on Incremental Continuous Ambulatory Peritoneal Dialysis Kidney International Reports icodextrin peritoneal dialysis ultrafiltration |
| title | The Double-Icodextrin Dose Randomized Controlled Trial of a Double Icodextrin Dose for Older Patients on Incremental Continuous Ambulatory Peritoneal Dialysis |
| title_full | The Double-Icodextrin Dose Randomized Controlled Trial of a Double Icodextrin Dose for Older Patients on Incremental Continuous Ambulatory Peritoneal Dialysis |
| title_fullStr | The Double-Icodextrin Dose Randomized Controlled Trial of a Double Icodextrin Dose for Older Patients on Incremental Continuous Ambulatory Peritoneal Dialysis |
| title_full_unstemmed | The Double-Icodextrin Dose Randomized Controlled Trial of a Double Icodextrin Dose for Older Patients on Incremental Continuous Ambulatory Peritoneal Dialysis |
| title_short | The Double-Icodextrin Dose Randomized Controlled Trial of a Double Icodextrin Dose for Older Patients on Incremental Continuous Ambulatory Peritoneal Dialysis |
| title_sort | double icodextrin dose randomized controlled trial of a double icodextrin dose for older patients on incremental continuous ambulatory peritoneal dialysis |
| topic | icodextrin peritoneal dialysis ultrafiltration |
| url | http://www.sciencedirect.com/science/article/pii/S2468024925003390 |
| work_keys_str_mv | AT ericgoffin thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT clemencebechade thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT cecilecourivaud thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT catherinebresson thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT francoiseheibel thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT jeanclaudestolear thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT karlienfrancois thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT fatoumatoure thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT didieraguilera thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT francoisvrtovsnik thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT bertbammens thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT micheljadoul thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT olivierdevuyst thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT martinwilkie thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT aureliebertrand thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT thierrylobbedez thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT ericgoffin thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT bertbammens thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT joellenortier thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT drphilippebovy thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT drjeanclaudestolear thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT karlienfrancois thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT droliviermat thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT francoisvrtovsnik thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT drdidieraguilera thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT thierrylobbedez thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT lucfrimat thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT drmariefrancoisenogier thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT dralexandreklein thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT cecilecourivaud thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT drmarckribs thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT fatoumatoure thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT iainmacdougall thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT martinwilkie thedoubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT ericgoffin doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT clemencebechade doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT cecilecourivaud doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT catherinebresson doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT francoiseheibel doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT jeanclaudestolear doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT karlienfrancois doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT fatoumatoure doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT didieraguilera doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT francoisvrtovsnik doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT bertbammens doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT micheljadoul doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT olivierdevuyst doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT martinwilkie doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT aureliebertrand doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT thierrylobbedez doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT ericgoffin doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT bertbammens doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT joellenortier doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT drphilippebovy doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT drjeanclaudestolear doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT karlienfrancois doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT droliviermat doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT francoisvrtovsnik doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT drdidieraguilera doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT thierrylobbedez doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT lucfrimat doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT drmariefrancoisenogier doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT dralexandreklein doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT cecilecourivaud doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT drmarckribs doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT fatoumatoure doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT iainmacdougall doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis AT martinwilkie doubleicodextrindoserandomizedcontrolledtrialofadoubleicodextrindoseforolderpatientsonincrementalcontinuousambulatoryperitonealdialysis |