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| ORIGINAL ARTICLE |
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| Year : 2020 | Volume
: 38
| Issue : 1 | Page : 16-24 |
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Randomized controlled trial to compare the tolerability and efficacy of treatment with Icodextrin 7.5% versus Dextrose 2.5% in chronic peritoneal dialysis patients with high/high average solute transport characteristics and low residual renal function
Vivek Sood1, Rahul Grover1, Vivek Kumar1, Shravan Kumar Singh2, Krishan Lal Gupta1
1 Department of Nephrology, PGIMER, Chandigarh, India
2 Department of Urology, PGIMER, Chandigarh, India
| Date of Submission | 26-Sep-2019 |
| Date of Decision | 17-Jan-2020 |
| Date of Acceptance | 30-May-2020 |
| Date of Web Publication | 31-Dec-2020 |
Correspondence Address:
Prof. Krishan Lal Gupta
Former Head of Department of Nephrology, Postgraduate Institute of Medical Education and Research, Chandigarh - 160 012
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/IOPD.IOPD_5_19
Aim: Comparison of tolerability and efficacy of treatment with icodextrin vs. dextrose 2.5% amongst high risk cohort of chronic peritoneal dialysis patients (high/high average solute transport characteristics and low residual renal function) over 3 months.
Study Design and Methodology: The study was an open-label, comparative, prospective, randomized controlled trial, conducted at department of Nephrology, Postgraduate Institute of Medical Education and Research, Chandigarh, India. A total of 349 end stage renal disease patients on chronic peritoneal dialysis were screened for eligibility over a period of 6 months and 41 patients with high / high average solute transport characteristics and low residual renal function were randomized to receive either icodextrin 7.5% solution or 2.5% dextrose solution in long dwell. Patients were assessed for adequacy of peritoneal dialysis (creatinine & urea clearance), peritoneal membrane transport characteristics including solute clearance (standard peritoneal equilibration test), body composition, total body water, fat mass and fat free mass (using whole body tetrapolar bioimpedance analyzer) at baseline and at the end of 3 months.
Statistical Analysis: Continuous variables were compared with independent samples paired t test if normally distributed, or with Mann–Whitney U test if the distribution was skewed. Categorical variables were analyzed with Chi-square test or Fisher exact test as appropriate. Pearson's correlation coefficient was calculated between different quantitative variables. Paired t test and Wilcoxon signed-rank test were used for within-group comparisons. Repeated measure ANOVA was used to compare bioelectrical impedance between intervention groups.
Results: The study has shown that use of icodextrin based continuous ambulatory peritoneal dialysis resulted in better ultrafiltration and improved solute clearance when compared to 2.5% dextrose based peritoneal dialysis in a select cohort of patients having high/high average transporter characteristics with poor residual renal function, however, it didn't significantly alter total body water and failed to translate into improvements in either patient's or physician's assessment of global health of response to therapy atleast at 3 months.
Conclusions: Although use of icodextrin based peritoneal dialysis solution for long dwell resulted in significant improvement in solute clearance and ultrafiltration nevertheless failed to translate into better hydration status or subjective improvement scores atleast at 3 months.
Keywords: High risk continuous ambulatory peritoneal dialysis patients, icodextrin 7.5% , ultrafiltration
How to cite this article:
Sood V, Grover R, Kumar V, Singh SK, Gupta KL. Randomized controlled trial to compare the tolerability and efficacy of treatment with Icodextrin 7.5% versus Dextrose 2.5% in chronic peritoneal dialysis patients with high/high average solute transport characteristics and low residual renal function. Indian J Perit Dial 2020;38:16-24 |
How to cite this URL:
Sood V, Grover R, Kumar V, Singh SK, Gupta KL. Randomized controlled trial to compare the tolerability and efficacy of treatment with Icodextrin 7.5% versus Dextrose 2.5% in chronic peritoneal dialysis patients with high/high average solute transport characteristics and low residual renal function. Indian J Perit Dial [serial online] 2020 [cited 2023 May 29];38:16-24. Available from: http://www.ijpd.org.in/text.asp?2020/38/1/16/305754 |
| Introduction | |  |
Fluid overload in patients on chronic peritoneal dialysis (PD) may be due to excess of fluid intake, insufficient ultrafiltration (UF), or a combination of both. Ultrafiltration failure (UFF), an important cause of technique failure[1] increases with time on treatment,[2] partly due to loss of residual renal function (RRF), but also because of acquired changes in peritoneal membrane function,[3] with rapid absorption of glucose and consequent loss of osmotic gradient. Patients having high transport characteristics often require hypertonic glucose exchanges in their long dwell period in order to prevent their net reabsorption of fluid, which may increase body fat and adversely effect, both locally (peritoneal membrane) as well as systemically through metabolic abnormalities (hyperinsulinemia and hyperlipidemia). Issue of subclinical overhydration in PD patients necessitated alternative osmotic agents for adequate control of fluid status. Icodextrin is a starch-derived, high molecular weight glucose polymer, which promotes sustained UF during prolonged intra-peritoneal dwells (up to 16 h). Patients with impaired UF, particularly in the setting of acute peritonitis, high transporter status and diabetes, appear to derive the greatest benefit from icodextrin with respect to augmented UF, amelioration of symptomatic fluid retention and possible prolongation of technique survival, besides improved glycaemic control in diabetic patients. In this context, the present study aimed to compare tolerability and efficacy of treatment with icodextrin vs. 2.5% dextrose amongst chronic PD patients with high / high average solute transport characteristics and low residual renal function over 3 months.
| Subjects and Methods | | |
Study design
The study was an open-label, comparative, parallel-group, prospective single center trial, conducted at department of Nephrology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. All consecutive end stage renal disease (ESRD) patients on chronic PD attending the PD clinic over a period of 6 months were screened for eligibility. Inclusion criteria were age between 18 to 75 years, on CAPD for at least 1 month, hypertension (BP ≥140/90 mm Hg) either with or without treatment, high/high average peritoneal solute transport characteristics (4 hour D/P creatinine ratio >0.65), urine output <750 ml/day and ability to tolerate a dialysis regimen that included a long dwell of >8 hour with 2.5% dextrose with fill volume of 2L. Exclusion criteria were history of allergy to cornstarch, suspected/known diagnosis of glycogen storage disease, history of recent (last 1 month) or current exposure to icodextrin/any other non-glucose solution, history of recent or current PD peritonitis, active exit site infection, history of non-compliance to PD prescription, use of only 1.5% glucose for all exchanges, pregnant or lactating females and life expectancy of less than 6 months. All patients provided written informed consent before enrolment.
Study methodology
At enrolment, subjects were randomized in 1:1 ratio using an encrypted, secure web-based system to receive either Icodextrin 7.5% PD solution or dextrose 2.5% PD solution in long dwell and followed up for 3 months. After baseline visit, patients were followed up at the end of 1st month (visit 2) and 3rd month (visit 3). In all visits, patients were thoroughly evaluated for symptoms and signs of uremia and fluid overload. Post-randomization patients who failed to follow-up after the baseline visit, withdrew consent, or deviated from study protocol {either due to non-compliance or as mandated by the investigator in the best interest of patient, e.g. switch over to automated peritoneal dialysis (APD) or hemodialysis} were considered for intention to treat analysis, however were precluded from per-protocol analysis. Laboratory tests at visit 1 and 3 included hematological and biochemical profile. Serum samples were stored for all the subjects at first and third month visit at -200 C for estimation of highly sensitive C reactive protein (hs CRP). Extended range flex reagent cartridge based on particle enhanced turbidimetric immunoassay technique was used for determination of CRP, whereby latex particles coated with antibody to CRP aggregate in presence of CRP in serum. The assay had a range from 0.5 to 250 mg/liter.
Assessment of PD adequacy (creatinine & urea clearance) and peritoneal membrane transport characteristics and solute clearance as estimated by standard peritoneal equilibration test (PET) using PD Adequest 2.0 software. Body composition, total body water (TBW), fat mass (FM) and fat free mass (FFM), were estimated by measuring body resistance with a standard whole body tetrapolar bioimpedance analyzer (Maltron Bio Scan), after adhering to following prerequisites: 8 hours fasting, 4 hours abstinence from exercise and half hour after CAPD exchange. Two electrodes each were placed at a distance of 5 cm on right foot and right hand. Measurements were taken with subject lying supine on a non-conductive surface with arms and legs slightly abducted from the trunk and after 15 minutes of rest. TBW was assessed using single frequency bioelectric impedance analysis (sf BIA). Net UF was determined by difference in weight of dialysate drained at the end of long dwell and solution administered at the start of long dwell. Both investigator and the patient assessed tolerability on a five point Likret scale (excellent, very good, good, poor or very poor) at the end of study period. At each visit, any information about inter-current illnesses, any therapeutic interventions (medical or surgical) and concomitant medication were obtained and clinical adverse events were recorded.
Outcomes
The primary objective was to compare the differences between two treatment groups (Icodextrin 7.5% and Dextrose 2.5% for long dwell) with respect to the change in the body weight. Primary efficacy measure was the mean change in TBW and fluid status over 1 month and 3 months. Secondary efficacy measures included change in net UF at 1 month and 3 months, patient's and investigator's global assessment of disease status as well as response to therapy, mean change in creatinine and urea clearance after 3 months, change in the status of peritoneal membrane solute removal using PET, mean change in hs CRP, total cholesterol and triglycerides, RRF (i.e. urine output) after 3 months and to determine the mean change in number of antihypertensive medications used at the end of therapy from baseline.
Statistical analysis
Assuming dropout rate of 20%, sample size of atleast 40 subjects (20 in either group) was required to detect absolute difference [standard deviation (SD) ± 5%] between the two groups with 80% power and two sided α of 0.05. All enrolled patients with non-missing outcome data were included for analysis. Descriptive statistics were used to describe the characteristics of study subjects. Data has been presented as mean ± SD (95% Confidence interval) and median (interquartile range) as appropriate. Continuous variables were compared with independent samples paired t test if normally distributed, or with Mann–Whitney U test if the distribution was skewed. Categorical variables were analyzed with Chi-square test or Fisher exact test as appropriate. Normality of data was checked using graphics (histograms, box and whisker plots, Q-Q plots) and statistically by measures of skewness and kurtosis and Kolmogorov Smirnov tests of normality. Pearson's correlation coefficient was calculated between different quantitative variables. Paired t test and Wilcoxon signed-rank test were used for within-group comparisons. Repeated measure ANOVA was used to compare bioelectrical impedance between intervention groups. Two-tailed P values <0.05 were considered statistically significant. Analyses were conducted using SPSS software for Macintosh, version 21.0 (IBM SPSS, Chicago, IL).
Ethical considerations
The study did not entail any additional risk over and above of what was conferred by subject's underlying disease status. Participation in this study was absolutely voluntary and subjects who refused to participate or excluded by the investigator post-randomization were continued treatment at our center without any bias or discrimination. Study protocol was approved by institute's ethical committee. All data was stored pseudonymously in a confidential manner.
| Results | | |
A total of 349 chronic PD patients were screened and assessed for eligibility, however only 41 patients satisfying both inclusion and exclusion criteria were enrolled [Figure 1] and randomized (1:1) to receive either icodextrin 7.5% solution (N = 20) or continue CAPD prescription unaltered with 2.5% dextrose solution in long dwell (N = 21). In Icodextrin arm, 3 patients didn't follow-up and 17 patients completed allocated treatment, whereas in 2.5 % dextrose arm, 4 patients didn't follow-up and 17 patients completed allocated treatment. Despite more number of anti-hypertensive drugs in icodextrin arm [Table 1], the two groups were well matched at baseline including diuretics in optimally tolerated dosages. One patient in each group was receiving 4 exchanges/day, rest all were on 3 exchanges/day.
Subjective assessment
Majority of the patients in both groups were having symptoms of uremia and fluid overload at study initiation. Except for nausea, majority had improvement of symptoms and signs in icodextrin group compared to dextrose group, although these differences were not statistically significant [Table 2]. Similarly, there was no significant difference with regard to patients or physicians global assessment of health amongst the two groups [Table 3].
Efficacy assessment
At baseline, control group was having better UF [Table 4] during the long dwell (311 ml vs. 169 ml) although there were no significant differences in the total 24 hour UF volumes. The control group was also having better total creatinine and BUN clearance. Out of 41 patients enrolled in the study, 21 patients (icodextrin group-10, control group-11) had significant RRF (urine output >100 ml/day) at baseline. There were no significant differences in mean urine volume amongst the two groups. However, RRF was contributing significantly more towards the dialysis dose in control arm at the beginning of the study and better solute clearance noted in the control group was attributable to a better RRF.
There was marked improvement in UF during the long dwell in icodextrin arm, at the end of 3 months (588 ml vs. 306 ml) as compared to the beginning of study where control population had better UF. Likewise, 24 hour UF improved in icodextrin arm (from 1183 ml to 1418 ml), although not statistically significant. Corresponding with an increase in UF volume, significant increase was also observed in total weekly creatinine clearance, weekly Kt/V urea, total and dialysate BUN clearance in icodextrin group, while no significant changes were noted in control arm [Table 5].
Dialysis adequacy
Majority of the study subjects were not meeting solute clearance targets at the beginning of the study. Considering control cohort first, majority had poor solute clearances with Kt/V <1.5 in 47% and <1.7 in 70% at baseline, with no change in these frequencies at the end of 3 months. Total creatinine clearance of <45 L/week/1.73 m2 was seen in 17% at baseline and 35% at 3 months, similarly total creatinine clearance of <60 L/week/1.73 m2 was seen in 53% at baseline and 70% at 3 months follow up. Likewise, the icodextrin arm also had low solute clearances with Kt/V urea <1.5 in 79% and <1.7 in 94% of subjects at baseline. However, after 3 months of therapy, there was significant improvement in the solute clearance with Kt/V <1.5 in only 19% and <1.7 in 31% of cohort. Similarly, total creatinine clearance was <40L/week/1.73 m2 in 16% and <45 L/week/1.73 m2 in 31% at start of study, while at 3 months follow up, none had creatinine clearance <40 L/week/1.73 m2 and only 12.5% had creatinine clearance <45 L/week/1.73 m2.
Body composition and fluid status
BIA was used for measured and derived indices. There was no difference in measured body weight and TBW in either group. Similarly, there were no significant changes in FM and FFM over 3 months [Table 6]. However, significant change was observed in the control group with increase in intra cellular water (ICW) while extra cellular water (ECW) had decreased. Similar findings were seen when % ratios of ICW to TBW and ECW to ICW were analyzed. Likewise, body cell mass was estimated to be greater at both 1 and 3 month follow up as compared to baseline value in the control population. However, at 3 months there were no significant differences in mean values of ICW amongst the two groups.
Residual renal function
At end of 3 months, fewer subjects in icodextrin arm had significant RRF compared to controls (35.3% vs. 63.3%; P = 0.23), although differences were not statistically significant. Urine volume decreased by a mean of 43.5 + 124.3 ml (p = 0.168) in icodextrin arm and it declined by 162.6 + 381.1 ml (p = 0.10) in the control arm. At baseline RRF was contributing more towards solute clearance, but at 3rd month these differences were no longer significant, although trend persisted.
Markers of chronic inflammation
No significant difference was apparent between the two groups in the mean hs CRP levels at baseline and at end of 3 months [Table 7]. Mean hs CRP levels declined in the control group by 2.12 ± 9.97 mg/l (P = 0.518). In the icodextrin group, mean levels of hs CRP increased by 21.71 ± 50.86 mg/l (P = 0.134). Serum albumin was better preserved amongst patients in control arm. There was no significant change in lipid profile in either of the two groups at three months of study [Table 8].
Anti-hypertensive drugs
There was a trend towards decrease in number of antihypertensive medications in the icodextrin arm at 3 months (3 ± 1.3 to 2.47 ± 1.5, mean change 0.53, P = 0.12). There was no change in the mean number of anti-hypertensive medications used in the control group (1.94 ± 1.4 vs. 2.0 ± 1.62, mean change 0.05, P = 0.80). At the end of 3 months, there was no significant difference in the mean number of antihypertensive medications including diuretics [2.47 ± 1.5 and 2.0 ± 1.6 in icodextrin and control arm respectively; (P = 0.387)] amongst the two groups.
| Discussion | | |
The current study has shown that although use of icodextrin based PD solution in long dwell in high risk cohort (high or high average solute transport characteristics with low RRF) results in significant improvement in solute clearance and UF volume, nevertheless it fails to translate into better hydration status or subjective improvement scores atleast at 3 months.
It is believed that as many as half of the patients on CAPD in Indian setup may have a high/high average peritoneal membrane transport characteristics,[4] which translates to reduced creatinine clearance, increased peritoneal protein loss as well as poor UF capacity, implying worse clinical outcomes as evident in CANUSA[5] study and further validated by ANZDATA registry.[6] Both high transporter status and lower UF are interlinked and it remains difficult to find an independent association with patient outcomes as observed in EAPOS[7] study which looked prospectively at anuric patients on automated PD (APD) for effect of UF and demonstrated that patients achieving <750 ml/day UF had higher mortality and solute transport was not a predictor of outcome in this study, unlike poor RRF which relates to poorer clinical outcome.[8] Therapeutic strategies to mitigate effect of high transporter status on solute transport include utilization of APD (short exchanges with drainage before re-absorptive process takes over), use of icodextrin (slow but linear UF thus preventing reabsorption nearly completely) or combination of both with APD during night and long day time dwell with icodextrin or utilization of higher dextrose concentration based solutions.
In current study, we substituted icodextrin for long exchange to mitigate effects of high transport characteristics of peritoneal membrane.[9] Hypothesis postulated for worse clinical outcome with high transport status or lower UF include ongoing inflammation, which results in an increase in peritoneal blood flow and consequent increased permeability of the microvasculature to proteins, leading to faster small solute transport. Secondly, membrane solute transport characteristics[10] (rapid absorption of small molecular weight osmoles i.e., glucose) leads to decreased efficiency of UF and subsequent fluid overload state with hypertension that correlates with greater cardiovascular risk. Additionally, higher dextrose concentration based PD solutions may lead to systemic metabolic effects that may add on to adverse outcomes.
In the current study we investigated both, the effect of icodextrin on volume status by serially measuring for change in body weight and by BIA as well as the effect on inflammation by looking at the effect of high sensitive CRP levels. The study groups were having similar 24 hour UF at baseline (icodextrin: 1183 + 443 ml vs. controls: 1279 + 522 ml, P = 0.537). After 3 months, there was a significant increase in 24 hour UF to 1418 + 365 ml in icodextrin group, which was predominantly accounted by improvement in UF in the long dwell (169 + 132ml to 588 + 187 ml). The net UF achieved with icodextrin in the 10 hour dwell in the current study (588 + 187 ml) is similar to that achieved in the MIDAS study and North America CAPD trial. The results of increased efficacy in inducing UF compared to dextrose amongst high transporters have been previously reported.[11] The increase in UF achieved expectedly was associated with an increase in delivered dialysis dose as estimated by KT/V urea and creatinine clearance. The total BUN clearance increased by 20.36 + 20.23 liters per week and was accounted mainly by an increase in dialysate BUN of 17.78 + 26.5 liters per week. Similarly, the total creatinine clearance increased by 11.04 + 8.99 liters per week and total weekly KT/V urea increased by 0.47 + 0.55. At three months only 31% of patients in icodextrin arm had KT/V <1.7 (18.75%; <1.5). There were no significant changes in the control arm. The results highlight efficacy of icodextrin in improving solute clearance as well as UF in high and high average transporters.
The effect of better UF achieved in the icodextrin arm on the hydration status was explored next and patients were assessed for presence of anasarca. In icodextrin arm anasarca persisted in only 1/6 patients who had it initially while 2 new patients in control arm developed anasarca in addition to 3 who had it initially. Similarly, 6/11 patients in icodextrin arm as compared to 8/10 in control arm who had edema initially, continued to have clinical edema and 1 as compared to 2 patients developed new onset edema in icodextrin arm. Thus, although clinically a trend towards lesser fluid overload was seen in patients receiving icodextrin, however, it failed to approach statistical significance. We observed that although the control group had a clear reduction in ECW, yet there was no net change in TBW consequent to an increase in ICW. On the other hand, icodextrin group which was overhydrated at baseline with relatively higher TBW and ICW, interestingly, had an increase in the ECW without a corresponding decrease in ICW despite an increase in net UF.
To put in a nutshell, icodextrin use although achieved better UF, nevertheless failed to produce any significant change in the fluid status as assessed by BIA at least at 3 months. This is in contrast with most of the studies where a consistent decline in ECW has been noted, however still can be explained firstly by the fact that body water composition is not a simplistic model relying on UF[12] alone and other factors like RRF, fluid and salt intake may all have an impact on water balance.[13] Secondly, icodextrin molecules being osmotically active tend to remain intravascularly and might therefore explain the increase in ECW component.
Decline in RRF with increased UF as seen in icodextrin arm [4/10 patients as compared to only 1/11 patients in control arm (odds ratio 2.36, P = 0.105)] is fairly well documented.[14] In MIDAS study, nighttime use of icodextrin had no influence on day time UF. However, in the current study, although the nighttime UF with icodextrin increased by around 341 ml, the total UF increased by only 235 ml/day, suggesting that there may be some decrease in the day time UF with its use. A decline in RRF in the icodextrin arm along with some decline in daytime UF could have mitigated the beneficial effects of increased nighttime UF to some extent.
Majority of the patients in the current study were clinically overhydrated as assessed by presence of edema, raised JVP etc., The mean number of antihypertensive drugs being used was also high. Thus, it seems plausible that subjects would have a higher total body sodium load, possibly required proportionately longer duration for clinically significant changes in body water and 3 month duration as in index study might have been short enough for evident clinical consequences. Further, the study was limited by the fact that direct measurement of TBW by deuterium dilution and ECW by sodium bromide tracer dilution techniques or the FM by DEXA as a part of body composition analysis were not used. sf BIA used in current study might not have been sensitive enough to pick up smaller differences, especially in overhydrated patients.[15],[16],[17] As hypertension control is closely linked to volume status, trend towards improvement in fluid status in icodextrin arm [RR for anasarca: 0.20 (p = 0.072) and edema: 0.70 (p = 0.3)] observed may possibly explain requirement of lesser antihypertensive drugs in icodextrin arm (mean change 0.53 in icodextrin arm vs. 0.05 in control arm, P = 0.12).
There is a controversy regarding effect of icodextrin on the inflammatory milieu. Icodextrin being glucose free was anticipated to be more biocompatible than dextrose based solutions by avoiding problems of glucose degradation products. However, activation of systemic and peritoneal inflammation[18] as well as allergic skin rash in 5% and sterile peritonitis in <1% has been documented with use of icodextrin based solution. Nevertheless, subsequent studies have refuted clinically relevant peritoneal inflammation with icodextrin[19], and etiology for sterile peritonitis has been attributed to a peptidoglycan contaminant (released from Alicyclobacillus acidocaldarius, a thermophilic gram-positive organism contaminating cornstarch used for icodextrin production) in certain batches of solution which has now been eliminated.[20] Further, trials have not documented any increase in rate of sterile peritonitis with use of icodextrin[21]. Likewise absence of any difference in hs CRP levels in the two arms further validates lack of inflammatory potential of icodextrin. Frequency of infectious complications was not different amongst the two arms as reported.[22] Overall 3 patients died in the study prior to the second visit itself due to acute stroke (n = 2) and acute coronary syndrome (n = 1).
Icodextrin use for once-daily long-dwell PD has shown to have clinical benefit in patients not meeting UF targets and at risk for fluid overload in a recent systematic review and meta-analysis of 19 randomized controlled trials.[23] Our study has likewise demonstrated better UF and improvement in the delivered dialysis dose in icodextrin arm, however impact on either the physician and patient's global assessment of overall health or their assessment of response to therapy was not observed. This is plausible as significant number of patients were still receiving a lower than recommended dialysis dose. Also, improvement might have been masked by a smaller sample size and shorter study duration.
| Conclusion | | |
Use of icodextrin based PD although resulted in better UF and improved solute clearance when compared to dextrose based CAPD in a select cohort of patients having high/high average transporter characteristics with poor RRF, however, it didn't significantly alter TBW and failed to translate into improvements in either patient's or physician's assessment of global health of response to therapy at 3 months. With a small sample size and a short follow-up, it would be difficult to draw any conclusions, nevertheless it sets the stage for further studies with larger sample size and longer follow-up.
Acknowledgement
Department of Nephrology and Urology.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]
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