The Effect of Neutral Peritoneal Dialysis Solution with Low Glucose-Degradation-Product on the Fluid Status and Body Composition--A Randomized Control Trial

Abstract

Background: Previous studies report conflicting results on the benefit of peritoneal dialysis (PD) patients treated with low glucose degradation product (GDP) solution. The effects of low GDP solution on body fluid status and arterial pulse wave velocity (PWV) have not been studied.

Methods: We randomly assigned 68 incident PD patients to low GDP (Intervention Group) or conventional solutions (Control Group); 4 dropped off before they received the assigned treatment. Patients were followed for 52 weeks for changes in ultrafiltration, residual renal function, body fluid status and arterial PWV.

Result: After 52 weeks, Intervention Group had higher overhydration (3.1 ± 2.6 vs 1.9 ± 2.2 L, p = 0.045) and extracellular water volume (17.7 ± 3.9 vs 15.8 ± 3.1 L, p = 0.034) than Control Group. There was no significant difference in PWV between groups. There was no significant difference in residual renal function between the Groups. Intervention Group had lower ultrafiltration volume than Control Group at 4 weeks (0.45 ± .0.61 vs 0.90 ± 0.79 L/day, p = 0.013), but the difference became insignificant at later time points. Intervention Group had lower serum CRP levels than Control Group (4.17 ± 0.77 vs 4.91 ± 0.95 mg/dL, p < 0.0001).

Conclusion: Incident PD patients treated with low GDP solution have less severe systemic inflammation but trends of less ultrafiltration, and more fluid accumulation. However, the effects on ultrafiltration and fluid accumulation disappear with time. The long term effect of low GDP solution requires further study.

Trial registration: ClinicalTrials.gov NCT00966615.

Conflict of interest statement

Competing Interests: This study was supported in part by the Fresenius Medical Care. Dr. CC Szeto receives research support from Fresenius Medical Care as well as research grant and consultancy from Baxter Healthcare. There are no patents, products in development or marketed products to declare. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.

Figures

Fig 1. Consort diagram of the trial profile.

Fig 2. Body composition and fluid status during the study period.

(A) body weight; (B) extracellular-to-intracellular fluid (E:I) ratio; (C) overhydration (OH); (D) lean tissue mass (LTM); (E) adipose tissue mass (ATM); (F) total body water (TBW); (G) extracellular water (ECW); and (H) intracellular water (ICW). Error bars denote standard deviations; P values denote the comparison between the Intervention and Control Groups by the unpaired Student’s t test.

Fig 3. Change in pulse wave velocity (PWV) during the study period.

(A) carotid-femoral; and (B) carotid-radial PWV. Whister-box plots, with boxes indicate median, 25th and 75th percentiles, whiskers indicate 5th and 95th percentiles. P values depict the comparison between the Intervention and Control Groups by the unpaired Student’s t test. (Grey box, Intervention Group; White box, Control Group).

Fig 4. Fluid removal, dialysis adequacy, and residual renal function during the study period.

(A) ultrafiltration volume by peritoneal dialysis; (B) urine output; (C) weekly total Kt/V; and (D) residual glomerular filtration rate (GFR). Error bars denote standard deviations; P values denote the comparison between the Intervention and Control Groups by Mann-Whitney U test. (Grey box, Intervention Group; White box, Control Group).

Fig 5. Serum C-reactive protein (CRP) during the study period.

Error bars denote standard deviations; P values denote the comparison between the Intervention and Control Groups by the Student’s t test. (Grey box, Intervention Group; White box, Control Group).