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Table 1 Details of included studies

From: Comparison of clinical effects between icodextrin and glucose solutions on outcomes of peritoneal dialysis: systematic review and meta-analysis of randomized controlled trials

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).

Konings CJ et al. [21, 24]

・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

[12, 25]

・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.

Paniagua R et al. [2628]

・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.

Posthuma N et al. [15, 2933]

・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.

Wolfson M et al. [23, 34]

・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.