Study | Methods | Participants and sample size | Interventions | Outcomes | Notes |
---|---|---|---|---|---|
Chang TI et al. [10] | ・Study design: RCT ・Study follow-up period: 12 months | Adult PD patients (aged ≥ 20 years) with ESRD who were maintained on PD and had a measured urine volume ≥ 750 mL/day (n = 100) | Treatment group ・PD solution containing 7.5% icodextrin and 2 exchanges of 1.5% glucose-based solutions Control group ・1 exchange of ≥2.5% and 2 exchanges of 1.5% glucose-based solution | All-cause mortality Technical survival Adverse effects (peritonitis, rash) Peritoneal function Ultrafiltration | Daily urine volume decreased faster in the glucose solution group than in the icodextrin group. However, there were no differences in other outcomes. |
de Moraes TP et al. [18] | ・Study design: RCT ・Study follow-up period: 90 days | Adult non-diabetic patients on treatment with APD for at least 90 days and with a recent PET showing a D/P creatinine of > 0.50 (n = 60) | Treatment group ・2 L of 7.5% icodextrin during the long dwell Control group ・2 L of 2.5% glucose during the long dwell | All-cause mortality Adverse effects (peritonitis) Ultrafiltration Episodes of uncontrolled fluid overload | Ultrafiltration was significantly greater in the icodextrin group compared to control group (800 mL versus 586 mL). |
Davies SJ et al. [20] | ・Study design: RCT ・Study follow-up period: 6 months | Prevalent adult CAPD or APD patients aged ≥18 years; controlled or uncontrolled hypertension; high or high -average peritoneal solute transport, urine output ≤750 ml/day; dialysate prescription with a glucose concentration of 2.27% or greater (n = 50) | Treatment group ・7.5% icodextrin for the long dwell Control group ・2.27% glucose for the long dwell | All-cause mortality Episodes of uncontrolled fluid overload | There were significantly differences in ultrafiltration and total fluid loss at 3 months among the icodextrin group (399.0 ml, 373.8 ml, respectively) compared to the control group. |
Finkelstein F et al. [13] | ・Study design: RCT ・Study follow-up period: 2 weeks | APD patients aged ≥18 years with a long-dwell change and fill volume of 2.0–2.5 L of a 4.25% dextrose solution and of whom the results of PET were classified into high-average or high category (n = 92) | Treatment group ・7.5% icodextrin for the long dwell Control group ・4.25% glucose solution for the long dwell | Ultrafiltration Adverse effects (rash) | Net ultrafiltration was significantly greater with icodextrin than with 4.25% glucose at week 2 (− 239.7 versus 373.8 ml; p < 0.001). Rash occurred more often in the icodextrin group (11patients) compared with the control group (zero patient). |
・Study design: RCT ・Study follow-up period: 4 months | Prevalent adult patients on CAPD or CCPD (n = 40) | Treatment group ・7.5% icodextrin in place of glucose-containing fluid for the overnight dwell (patients on CAPD) or the daytime dwell (patients on APD) Control group ・Standard glucose-containing PD solutions | All-cause mortality Technical survival RRF (urine volume) Ultrafiltration | In contrast to the control group, ECW declined significantly in the icodextrin group. GFR decreased slightly, but significantly in the icodextrin group, but not in the control group. | |
Lin A et al. [11] | ・Study design: RCT ・Study follow-up period: 4 weeks | Prevalent CAPD patients stable at least 90 days, aged ≥18 years, were treated with a maximum of 6 L of daily 2.5% glucose dialysate with a night dwell above 8 h and a night dwell volume of 2 L for a minimum of 30 days before inclusion (n = 201) | Treatment group ・7.5% icodextrin in night dwell Control group ・2.5% glucose dialysate in night dwell | All-cause mortality Adverse effects (peritonitis, rash) | Following 2 and 4 weeks, Ccr and ultrafiltration were significantly higher in the icodextrin group versus the glucose group (p < 0.001). |
MIDAS Study | ・Study design: RCT ・Study follow-up period: 6 months | Adult CAPD patients aged ≥18 years and established on CAPD for at least 3 months using standard 3 to 4 exchanges with no more than one hypertonic glucose bag (n = 209) | Treatment group ・7.5% icodextrin as overnight dwell Control group ・Standard glucose-containing PD dialysate as overnight dwell | All-cause mortality Ultrafiltration Technical survival | The mean overnight ultrafiltration in the icodextrin group was 3.5 times greater than 1.36% glucose at eight hours and 5.5 times greater at 12 h and no different from that of 3.86% glucose group at eight hours and 12 h. |
Takatori Y et al. [16] | ・Study design: RCT ・Study follow-up period: 24 months | Patients with ESRD because of diabetic nephropathy and were newly started on PD (CAPD and APD) as a first RRT (n = 41) | Treatment group ・a maximum of 6 L of daily 1.5% or 2.5% of glucose PD dialysate in association with an overnight or daytime dwell of 2 or 1.5 L of 7.5% icodextrin Control group ・a maximum of 8 L of daily 1.5% or 2.5% of glucose PD dialysate | All-cause mortality Technical survival RRF (urine volume, GFR/CrCl), Peritoneal function Ultrafiltration Episodes of uncontrolled fluid overload | The technical survival rate was 71.4% in the icodextrin group and 45.0% in the glucose group. The icodextrin group showed better cumulative technical survival (log-rank test, p = 0.0365). The net ultrafiltration in the icodextrin group was significantly higher during study period than the glucose group. |
・Study design: open label, RCT ・Study follow-up period: 12 months | Adult prevalent PD patients with non-insulin-dependent diabetes mellitus; high-average and high peritoneal transport status in a simplified PET (n = 59) | Treatment group ・7.5% icodextrin in the long dwell Control group ・At least 1 bag with 2.5% glucose dialysate in the long dwell Liberal use of 2.5% or 4.25% glucose solution was allowed in both groups | Adverse effects (peritonitis) | Ultrafiltration remained higher in the icodextrin group than in the glucose group throughout the study. Adverse events related to fluid overload were more frequent in the glucose group compared to the icodextrin group. However, infectious peritonitis was similar in both groups. | |
Plum J et al. [14] | ・Study design: open label, RCT ・Study follow-up period: 14 weeks | Adult prevalent APD patients who were treated with APD during at least 90 days before the screening visit and whose PD prescription included a long-dwell daytime exchange (n = 39) | Treatment group ・7.5% icodextrin as daytime dwell Control group ・Daytime dwell of glucose-containing dialysate | RRF (average of creatinine and urea clearance) | After 12 weeks of treatment, RRF in the icodextrin group was 2.9 ± 0.8 ml/min/1.73m2, and this value did not differ from the control group, which was 1.7 ml/min/1.73m2. |
・Study design: open label, RCT ・Study follow-up period: 24 months | Adult prevalent CCPD patients aged ≥18 years, consisting of a 2-year treatment period on either icodextrin or glucose-containing solutions for the daytime dwell (n = 38) | Treatment group ・icodextrin for the daytime dwell Control group ・Daytime dwell of glucose-containing dialysate | All-cause mortality RRF (urine volume, GFR/CrCl) Adverse effect (peritonitis) Ultrafiltration | Daytime ultrafiltration volume and 24-h ultrafiltration volume increased significantly in icodextrin-treated patients at 3 and 6 months. However, while ultrafiltration at 9 and 12 months also increased, it did not reach statistical significance. | |
・Study design: open RCT ・Study follow-up period: Efficacy study (4 weeks) Safety study (52 weeks) | Adult prevalent PD patients aged ≥18 years (CAPD only in the efficacy study, APD/CAPD in the safety study) for at least 90 days before the screening visit and were treated with a standard dialysis for at least 30 days before the screening in a long dwell using a solution containing 2.5% glucose at a full volume (Efficacy study: n = 175, Safety study: n = 287) | Treatment group ・PD solution containing 7.5% icodextrin for the long dwell Control group ・2.5% glucose for the long dwell Dialysate volume was either 2 L or 2.5 L, depending on the patient’s usual prescriptions | All-cause mortality Adverse events (peritonitis, rash) | During the 1-year period, there were no significant differences in mortality rate between the icodextrin group and the control group. Overall period, 44 patients (16.6%) in the icodextrin group and 14 patients (7.1%) in the control group reported rash. | |
Yoon HE et al. [19] | ・Study design: RCT ・Study follow-up period: 12 months | ESRD patients starting CAPD (n = 80) | Treatment group ・2 L of 7.5% icodextrin during the long dwell Control group ・Four exchanges of glucose-containing dialysates Liberal use of 1.5%, 2.5%, 4.25% glucose-based dialysate was allowed in both groups | All-cause mortality Technical survival RRF (urine volume, GFR/CrCl) Peritoneal function Adverse effect (peritonitis) Ultrafiltration | The Glucose group showed a significant decline in urine volume at 6 and 12 months from 0 month, but the icodextrin group did not. |