Clinical efficacy and safety of icodextrin dialysate for overnight dwell in continuous ambulatory peritoneal dialysis: A prospective self-controlled study

Abstract

Objective

To analyze the clinical benefits of icodextrin in patients undergoing continuous ambulatory peritoneal dialysis to optimize treatment strategies.

Methods

This prospective single-arm, self-controlled observational study enrolled 50 peritoneal dialysis patients. All eligible participants were consecutively enrolled according to uniform inclusion and exclusion criteria during the study period. Each patient sequentially received 6 months of treatment with a standard peritoneal dialysis solution, followed by 6 months of treatment with an icodextrin-based solution. Written informed consent was obtained from all participants before study enrollment.

Results

Compared with the standard glucose-based solution phase, the subsequent 6-month icodextrin-based regimen significantly improved key clinical parameters. Significant increases were observed in 24-h ultrafiltration volume, Kt/V, serum albumin levels, and hemoglobin levels, whereas C-reactive protein and B-type natriuretic peptide levels significantly decreased (p < 0.05). There was a significant difference in the distribution of 24-h urine volume (p < 0.0001), and no severe adverse events were reported.

Conclusion

Overnight use of icodextrin dialysate in patients undergoing continuous ambulatory peritoneal dialysis can effectively enhance ultrafiltration and dialysis adequacy and improve inflammation, fluid overload, anemia, and malnutrition, with satisfactory safety. Icodextrin is a reliable option for individualized peritoneal dialysis regimen optimization.

Keywords

Icodextrin continuous ambulatory peritoneal dialysis ultrafiltration dialysis adequacy inflammation

Introduction

Peritoneal dialysis is an important renal replacement therapy for patients with uremia,¹ which is the main manifestation of end-stage chronic kidney disease. Dialysate selection is critical for treatment quality because conventional glucose-based dialysates, which rely on high osmotic pressure for ultrafiltration, have notable limitations.² Long-term use may lead to peritoneal fibrosis, ultrafiltration failure, and metabolic issues (e.g. blood glucose fluctuations and insulin resistance). It also fails to maintain effective ultrafiltration in patients with decreased peritoneal function, increasing the risks of volume overload and cardiovascular complications.³ In contrast, icodextrin, a new isotonic peritoneal dialysate that uses a glucose polymer as the osmotic agent (acting via colloid osmotic pressure), has distinct advantages: its ultrafiltration effect is unaffected by peritoneal transport characteristics; it reduces glucose-related metabolic adverse reactions; and it is effective in improving ultrafiltration volume, enhancing solute clearance, and protecting peritoneal function, making it ideal for long-term overnight dwell.^4,5 This prospective single-arm, self-controlled observational study enrolled 50 patients undergoing peritoneal dialysis who sequentially used conventional glucose-based and icodextrin-based dialysates for overnight dwell. The two regimens were compared with respect to ultrafiltration, solute clearance, and inflammation- and volume-related indicators to clarify the clinical value of icodextrin and provide a reference for optimizing peritoneal dialysis regimens.

Methods

Study design and population

This prospective study was conducted jointly at the Nephrology Center of The Second Affiliated Hospital of Nanchang University and Yingtan 184 Hospital from February 2024 to February 2025.

This study was approved by the Ethics Committee of Yingtan 184 Hospital, China RongTong Medical Healthcare Group Co. Ltd. (Yingtan, Jiangxi, China; Approval No.: YT184-2024-012; Approval Date: 15 January 2024). The study was performed in accordance with the ethical principles of the Helsinki Declaration of 1975, as revised in 2024. All patient personal and clinical information was fully de-identified to protect patient privacy, and no identifiable individual information is retained in the manuscript, tables, figures, or supplementary materials. The reporting of this study conforms to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for observational clinical studies.

Written informed consent was obtained from all patients; the study was approved by the Ethics Committee of Yingtan 184 Hospital. The main exclusion criteria were as follows: a history of peritonitis within 3 months before screening; planned or potential kidney transplantation during the study period; hypersensitivity to any component of icodextrin-based peritoneal dialysis solution; severe hepatic insufficiency (e.g. liver cirrhosis or active hepatitis) or HIV-positive status; malignant tumor or expected survival of less than 12 months; severe mental disorders, inability to comply with study procedures, or lack of appropriate caregivers; extensive peritoneal adhesions/fibrosis, an unhealed abdominal surgical wound, severe abdominal wall infection, or inability to undergo catheter placement; severe lactic acidosis, refractory heart failure, or severe pulmonary disease; a history of alcoholism or substance abuse within the previous 6 months; and any other condition judged by the investigators to make participation unsuitable.

All enrolled patients completed the standard peritoneal equilibration test (PET) before enrollment to determine peritoneal transport characteristics. Fourteen cases (28.0%) were classified as high transport type, 22 cases (44.0%) as high-average transport type, 10 cases (20.0%) as low-average transport type, and 4 cases (8.0%) as low transport type. No patients were excluded because of extreme peritoneal dysfunction.

Treatment and follow-up

A total of 50 patients undergoing peritoneal dialysis were enrolled in this self-controlled, before-and-after comparative study. All patients completed the study. The study consisted of two consecutive treatment phases. During the conventional treatment phase (first 6 months), patients received standard continuous ambulatory peritoneal dialysis (CAPD) daily, using glucose-based peritoneal dialysis solution (Baxter) at concentrations of 1.5% or 2.5%. The total dialysate fill volume per exchange was uniformly 2000 mL. The number of hypertonic (2.5% glucose) PD exchanges per day was recorded and remained unchanged throughout the two study phases. The treatment regimen consisted of four exchanges per day: three daytime exchanges with a dwell time of 4 h each and one overnight exchange with a dwell time of 8–10 h. Relevant clinical parameters were monitored monthly, for a total of six assessments. During the icodextrin treatment phase (the subsequent 6 months), the daytime glucose-based peritoneal dialysis protocol, dialysate fill volume, exchange frequency, dwell time, and number of hypertonic glucose exchanges remained unchanged. Only the final overnight exchange was switched to 7.5% icodextrin solution (Baxter), with a dwell time of 8–10 h. Strict aseptic technique was applied throughout both phases. Relevant clinical parameters were monitored monthly, for a total of six assessments. Throughout the 12-month follow-up period, all patients received standardized dietary guidance to maintain a stable low-salt diet and fixed daily water intake. The type, dosage, and administration frequency of diuretics remained unchanged during the two phases, and emergency cases requiring medication adjustment were excluded.

Study outcomes

Clinical parameters were collected at the end of the conventional treatment phase (baseline) and at the end of the icodextrin treatment phase.

Ultrafiltration: 24-h peritoneal dialysis ultrafiltration volume. Net ultrafiltration volume was calculated as the total drained effluent volume over 24 h minus the total dialysate infusion volume on the same day.

Solute clearance: Total Kt/V (urea clearance index) was divided into peritoneal Kt/V and residual renal Kt/V. All indices were calculated based on urea concentrations in 24-h urine and dialysate effluent, combined with the patient's body weight and body surface area.

Inflammatory marker: High-sensitivity C-reactive protein (hs-CRP), measured by immunoturbidimetry.

Volume overload marker: B-type natriuretic peptide (BNP), measured by electrochemiluminescence assay. Other parameters included hemoglobin, 24-h urine output, and serum albumin levels.

All laboratory measurements were performed by the clinical laboratory of our hospital in strict accordance with standardized operating procedures.

Statistical analysis

For continuous variables, normally distributed data were presented as mean ± standard deviation, and comparisons between the two groups were performed using independent-samples t tests. Non-normally distributed continuous variables were presented as median (interquartile range), and comparisons between the two groups were performed using the Mann–Whitney U test. For paired comparisons of indicators at different follow-up time points within the same population, the paired t test was used for normally distributed data, whereas the Wilcoxon signed-rank test was used for non-normally distributed data. Categorical variables and counting data were expressed as frequencies, proportions, or percentages (%). A p value < 0.05 was considered statistically significant. All analyses were performed using SPSS Statistics (version 29.0) and GraphPad Prism (version 9.0).

Results

Enrollment and baseline characteristics

This study enrolled 50 patients undergoing peritoneal dialysis, the majority of whom were middle-aged and older men, with a mean age of 58.6 years. Patients aged between 45 and 65 years accounted for 62.0%. Physical examinations indicated a normal body mass index (BMI) and slightly elevated blood pressure. The mean duration of dialysis was 25.3 months, and CAPD was the main modality (84.0%). Nearly half of the patients maintained a 24-h urine volume of ≥400 mL. The primary underlying renal diseases were diabetic nephropathy (42.0%) and hypertensive nephropathy (28.0%).

Comorbidities were highly prevalent, including hypertension in 94.0% of patients and type 2 diabetes mellitus in 48.0%, along with a certain proportion of cardiovascular diseases. Most patients presented with mild-to-moderate anemia, chronic inflammation, and fluid overload. Laboratory results confirmed uremic status and marked secondary hyperparathyroidism. Erythropoietin was required for anemia correction in 74.0% of patients. The dialysis adequacy index, Kt/V, was 1.48. The standard dialysate fill volume for each exchange was 2000 mL in all patients. Among all participants, 32 patients (64.0%) used one exchange of 2.5% hypertonic glucose solution daily, whereas 18 patients (36.0%) used no hypertonic glucose solution. These parameters were kept consistent during both treatment phases to avoid interference with ultrafiltration outcomes.

No patients were lost to follow-up, and detailed information is provided in Table 1 and Supplementary Table 1.

Table 1.

Demographics and baseline characteristics of participants (n = 50).

Category	Index	Data
Demographics	Male, n (%)	28 (56.0)
	Age (years), mean ± SD	58.6 ± 11.2
	Age stratification, n (%)
	<45 years	6 (12.0)
	45–65 years	31 (62.0)
	>65 years	13 (26.0)
Physical indicators	Body weight (kg), mean ± SD	64.2 ± 9.5
	Height (cm), mean ± SD	163.5 ± 7.8
	BMI (kg/m²), mean ± SD	23.9 ± 3.1
	Systolic BP (mmHg), mean ± SD	138.5 ± 15.2
	Diastolic BP (mmHg), mean ± SD	82.6 ± 9.4
Dialysis basic information	PD duration (months), mean ± SD	25.3 ± 10.6
	PD modality, n (%)
	CAPD	42 (84.0)
	APD	8 (16.0)
	Peritoneal transport type, n (%)
	High	14 (28.0)
	High-average	22 (44.0)
	Low-average	10 (20.0)
	Low	4 (8.0)
	Hypertonic glucose exchange, n (%)
	With 2.5% glucose	32 (64.0)
	Without hypertonic glucose	18 (36.0)
	Dialysate fill volume per exchange	2000 mL (uniform)
	24-h urine volume stratification, n (%)
	Anuria	13 (26.0)
	<400 mL	15 (30.0)
	≥400 mL	22 (44.0)
Primary disease and comorbidities, n (%)	Diabetic kidney disease	21 (42.0)
	Hypertensive nephropathy	14 (28.0)
	Chronic glomerulonephritis	10 (20.0)
	Polycystic kidney disease & Others	5 (10.0)
	Hypertension	47 (94.0)
	Type 2 diabetes mellitus	24 (48.0)
	Cardiovascular diseases	25 (50.0)
	Secondary hyperparathyroidism	19 (38.0)
Core laboratory indexes, mean ± SD	Hemoglobin (g/L)	104.3 ± 12.7
	Serum albumin (g/L)	34.6 ± 3.8
	Serum creatinine (μmol/L)	865.4 ± 214.3
	BUN (mmol/L)	22.7 ± 5.6
	Fasting blood glucose (mmol/L)	6.4 ± 1.8
	Intact PTH (pg/mL)	386.5 ± 124.7
	hs-CRP (mg/L)	9.26 ± 3.15
	BNP (pg/mL)	850.9 ± 269.5
Dialysis adequacy and Ultrafiltration	Total Kt/V, mean ± SD	1.48 ± 0.19
	Peritoneal Kt/V, mean ± SD	1.12 ± 0.15
	Residual renal Kt/V, mean ± SD	0.36 ± 0.08
	24-h ultrafiltration volume (mL), mean ± SD	465.4 ± 142.5
Anemia treatment	EPO usage, n (%)	37 (74.0)
Anemia treatment	Weekly EPO dosage (IU), mean ± SD	4280 ± 1150

Continuous variables are presented as mean ± standard deviation (SD); categorical variables are expressed as number of cases (percentage, %). All patients received a uniform dialysate fill volume of 2000 mL per exchange throughout the study. Peritoneal transport characteristics were assessed via peritoneal equilibration test (PET).

APD: automated peritoneal dialysis; BNP: B-type natriuretic peptide; BP: blood pressure; BUN: blood urea nitrogen; CAPD: continuous ambulatory peritoneal dialysis; EPO: erythropoietin; hs-CRP: high-sensitivity C-reactive protein; PD: peritoneal dialysis; PTH: parathyroid hormone.

Primary outcomes

The primary outcomes were 24-h ultrafiltration volume, 24-h urine volume and Kt/V. Consistently higher 24-h ultrafiltration volumes were observed across all time points (p < 0.0001, Figure 1). The mean 24-h ultrafiltration volume increased by 186.2 mL (absolute difference), representing a relative increase of 40.0% compared with the conventional phase. Compared with the conventional peritoneal dialysis solution group, the icodextrin group showed: a significantly different distribution of 24-h urine volume (p < 0.0001, Figure 2). Total Kt/V, peritoneal Kt/V, residual renal Kt/V were all significantly increased (all p < 0.0001, Figure 3). The total Kt/V increased by 0.21 in absolute value, representing a relative increase of 14.2%. These findings indicate that icodextrin-based peritoneal dialysis solution improves fluid management, preserves urine volume, and enhances dialysis adequacy in patients undergoing peritoneal dialysis.

Figure 1.

Comparison of 24-h peritoneal dialysis ultrafiltration volume between the conventional glucose-based solution and icodextrin-based solution phases. Data are presented as mean ± standard deviation. ****p < 0.0001 vs. the conventional phase.

Figure 2.

Comparison of distribution of 24-h urine volume between the conventional glucose-based solution and icodextrin-based solution phases. Data are presented as median (interquartile range). ****p < 0.0001 vs. the conventional phase.

Figure 3.

Comparison of Kt/V between the conventional glucose-based solution and icodextrin-based solution phases. Data are presented as mean ± standard deviation. ****p < 0.0001 vs. the conventional phase.

Secondary outcomes

Secondary outcomes included hs-CRP, serum albumin, BNP, and hemoglobin (Hb). Compared with the conventional group, the icodextrin group showed significantly lower hs-CRP and BNP levels as well as higher serum albumin and hemoglobin levels (all p < 0.0001; Supplementary Figures 1 to 4. Quantitative changes were as follows: hs-CRP decreased by 4.12 mg/L (absolute difference: relative reduction, 44.5%); BNP decreased by 396.7 pg/mL (absolute difference: relative reduction, 46.6%); serum albumin increased by 3.5 g/L (absolute difference: relative increase, 10.1%); and hemoglobin increased by 9.8 g/L (absolute difference: relative increase, 9.4%). These results confirm the favorable effects of icodextrin on systemic inflammation, nutritional status, volume overload, and anemia control in patients undergoing peritoneal dialysis.

Adverse events reported during the study

Adverse events were monitored and recorded throughout the follow-up period, with details presented in Table 1 (n = 50). A total of 28 adverse events occurred, yielding an overall incidence rate of 56.0%. The most common adverse event was abdominal pain/bloating discomfort (12.0%, 6 cases), followed by fluid overload (10.0%, 5 cases) and hyperglycemia/blood glucose fluctuation (8.0%, 4 cases). Infection-related adverse events, including peritonitis, catheter-related infection, and tunnel/exit-site infection, had a combined incidence of 12.0% (6 cases), with peritonitis (6.0%, 3 cases) being the most frequent subtype. Other adverse events (electrolyte disturbance, aggravation of malnutrition, allergy/rash, and others) occurred at low incidence rates (2.0%–6.0%). Importantly, no serious adverse events related to the study interventions (conventional or icodextrin-based peritoneal dialysis solution) were observed. When stratified by treatment group, the icodextrin group showed a trend toward a lower incidence of infection-related adverse events, which is consistent with its favorable safety profile observed in the overall secondary outcome analysis (Table 2).

Table 2.

Adverse events stratified by conventional glucose-based solution phase and icodextrin-based solution phase.

Adverse event	Conventional glucose-based solution phase (n = 50)	Icodextrin-based solution phase (n = 50)
Peritonitis	2 (4.0)	1 (2.0)
Catheter-related infection	1 (2.0)	1 (2.0)
Tunnel/exit-site infection	1 (2.0)	0 (0.0)
Fluid overload	4 (8.0)	1 (2.0)
Hyperglycemia/blood glucose fluctuation	4 (8.0)	0 (0.0)
Electrolyte disturbance	2 (4.0)	1 (2.0)
Abdominal pain/bloating discomfort	3 (6.0)	3 (6.0)
Allergy/rash	1 (2.0)	0 (0.0)
Aggravation of malnutrition	1 (2.0)	1 (2.0)
Other adverse events	1 (2.0)	0 (0.0)
Total adverse events	24 (48.0)	8 (16.0)

Data are presented as number of cases (percentage, %). No serious adverse events related to study interventions were reported in either phase.

Discussion

This well-designed and rigorously executed study provides compelling evidence supporting the clinical efficacy of icodextrin in patients undergoing CAPD. The results demonstrate substantial improvements in major clinical indicators, including 24-h ultrafiltration volume, Kt/V, serum albumin, and hemoglobin levels. Concurrently, significant reductions were observed in inflammatory markers such as CRP and BNP. These outcomes collectively highlight icodextrin’s substantial potential to optimize fluid management and improve overall clinical status in this vulnerable patient population.⁶ Comparison with related research and citation of literature: The promising findings of this study are consistent with and reinforce those of previous investigations.⁷ For instance, Goffin et al.⁴ demonstrated that icodextrin effectively enhances ultrafiltration and reduces the risk of volume overload in patients undergoing peritoneal dialysis. Furthermore, the observed improvements in systemic inflammation and nutritional parameters are consistent with findings reported by Li et al.⁸, who highlighted the role of icodextrin in attenuating inflammatory responses and improving nutritional outcomes in this patient population.⁵ Thus, the present data align coherently with the existing scientific corpus, strengthening the collective evidence base.^9,10 Elaboration on the Accuracy and Scientific Rigor of This Study: The robustness of these conclusions is supported by the study's careful methodological design and execution.¹¹ The comprehensive assessment of a multifaceted panel of clinical and biochemical parameters provides a holistic view of patient status.¹² The consistent directional changes observed across multiple endpoints—including fluid removal, dialysis adequacy, nutritional status, and inflammation—enhance the internal validity and biological plausibility of the findings. This convergence across diverse parameters suggests that the observed benefits are not isolated phenomena but rather reflect a coherent and favorable physiological impact attributable to icodextrin therapy.

Despite the meaningful findings yielded in this study, several inherent limitations should be acknowledged, which are essential for an objective interpretation of the results.¹³ First, the relatively small sample size (n = 50) represents the primary limitation of the present study. The sample size was determined by actual patient enrollment availability rather than a formal statistical sample size calculation, which may have limited the power to detect subtle treatment effects and reduced the external validity, thereby hindering the generalization of the conclusions to the entire CAPD patient population. Furthermore, although the 12-month study duration was sufficient to evaluate short-term efficacy, it was not adequate to fully assess the long-term sustainability of the observed clinical benefits as well as any delayed adverse or therapeutic effects.^14,15

Several specific methodological deficiencies also warrant discussion. First, baseline peritoneal membrane transport profiles were not documented in the study. Correspondingly, subgroup analyses based on key clinical indicators, including diabetic status, baseline urine volume, and residual renal function, were not performed. Further stratified investigations with larger cohorts are therefore required to clarify the differential efficacy of icodextrin across distinct patient subgroups.

Second, although major confounding factors, such as long-term dietary salt and water intake and regular diuretic use, were strictly controlled throughout the follow-up period, minor individual variations in daily lifestyle could not be entirely eliminated, which may have introduced unmeasured bias into the study results.

Third, the sample size was determined based on actual patient enrollment availability rather than a rigorous statistical sample size calculation, which may limit the reliability of the statistical analyses. In addition, the single-arm, self-controlled study design cannot completely rule out the confounding influence of the natural progression of renal disease during the 12-month observation period. Accordingly, well-designed randomized controlled trials are urgently needed to provide more high-level and robust clinical evidence supporting the application of icodextrin.

Exposition on the Research Value Provided by Icodextrin Peritoneal Dialysis Solution for Future Studies:¹⁶ This investigation makes a substantive contribution to the field by providing a detailed clinical profile of the effects of icodextrin,⁶ thereby establishing a robust foundation for subsequent research.¹⁷ The findings highlight several directions for future investigation, particularly the need for large-scale, multicenter randomized controlled trials with extended follow-up periods to further confirm efficacy and long-term safety.¹⁸ Furthermore, the results encourage exploration of the underlying mechanisms, including the effects of icodextrin on peritoneal membrane integrity, systemic metabolic pathways, and patient-reported outcomes such as quality of life.^19,20 By demonstrating clinically relevant benefits and posing new questions, this work supports the role of icodextrin-based solutions as a pivotal component in the ongoing optimization of dialysis management strategies.⁶ It may also contribute to the development of more effective, personalized treatment protocols aimed at improving survival and quality of life in patients undergoing CAPD.

Conclusion

This study suggests that overnight use of icodextrin dialysate may provide multiple clinical benefits for patients undergoing CAPD. It may increase 24-h ultrafiltration volume and dialysis adequacy, alleviate systemic inflammation and volume overload, and improve anemia and nutritional status, while maintaining a favorable safety profile. Icodextrin has potential value for the optimization of individualized peritoneal dialysis regimens.

Supplemental Material

sj-docx-1-imr-10.1177_03000605261464848 - Supplemental material for Clinical efficacy and safety of icodextrin dialysate for overnight dwell in continuous ambulatory peritoneal dialysis: A prospective self-controlled study

Supplemental material, sj-docx-1-imr-10.1177_03000605261464848 for Clinical efficacy and safety of icodextrin dialysate for overnight dwell in continuous ambulatory peritoneal dialysis: A prospective self-controlled study by Xiaojie Xie, Ran Zhang, Fengmei Huang, Yang Yang, Fang Zeng and Gaosi Xu in Journal of International Medical Research

Footnotes

Acknowledgements

Minor language polishing of this manuscript was performed using standardized academic writing tools. No artificial intelligence tools were used for study design, data collection, statistical analysis, or result interpretation.

ORCID iDs

Xiaojie Xie

Ethics approval and consent to participate

This study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of Yingtan 184 Hospital, China RongTong Medical Healthcare Group Co. Ltd. Written informed consent was obtained from all individual participants included in the study.

Consent for publication

Informed consent was obtained from all individual participants included in the study.

Authors’ contributions

Xiaojie Xie: Conceptualization, Formal Analysis, Software, Writing-original draft, Writing-review and editing. Ran Zhang: Data curation, Formal Analysis, Software, Writing-original draft. Fengmei Huang: Conceptualization, Methodology, Formal Analysis, Resources. Yang Yang: Data curation, Resources. Fang Zeng: Data curation, Resources. Gaosi Xu: Funding acquisition, Supervision, Writing-review and editing. Xiaojie Xie and Ran Zhang contributed equally to this work and share first authorship. All authors contributed to the article and approved the submitted version.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by the Science and Technology Program of the Jiangxi Provincial Administration of Traditional Chinese Medicine (No.: SZYYB20230880).

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Availability of data and materials

All data generated or analyzed during this study are included in this current article. The original research data can be provided for verification when required by the journal.

Supplemental material

Supplemental material for this article is available online.

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