Nephrol Dial Transplant (2006) 21: 1334–1339 doi:10.1093/ndt/gfi023 Advance Access publication 26 July 2005 Original Article Effect of radio contrast media on residual renal function in peritoneal dialysis patients—a prospective study Elisabeth Dittrich1, Heidi Puttinger1, Martin Schillinger2, Irene Lang3, Thomas Stefenelli3, Walter H. Hörl1 and Andreas Vychytil1 1 Department of Medicine III, Division of Nephrology and Dialysis, 2Department of Medicine II, Division of Angiology and 3Department of Medicine II, Division of Cardiology, Medical University Vienna, Währinger Gürtel 18–20, A-1090 Vienna, Austria Abstract Background. Residual renal function is an independent predictor of survival in peritoneal dialysis patients. Systemic administration of radio contrast media (CM) may increase the risk of acute renal failure in patients with impaired renal function not on dialysis. There are few data on the influence of CM administration in dialysis patients. Methods. We investigated residual renal function in 10 continuous ambulatory peritoneal dialysis (CAPD) patients who underwent elective diagnostic intravenous or intra-arterial administration of CM (study group). Iopromide (a iodinated, non-ionic hypoosmolar CM) was used for all interventions. The median dose of CM given was 107.5 ml/patient. Residual renal function (calculated as the average of renal creatinine and renal urea clearance) was measured on the day before the intervention (baseline), on days 1–7, day 10 and day 30 after intervention. Eight CAPD patients without exposure to CM acted as the control group. Results. There was no significant difference between the two groups in age, gender, diabetes, duration of dialysis and renal clearance at baseline. In the study group, we observed a temporary decline of residual renal clearance after administration of CM (P<0.05; Friedman test). On day 30, clearances were not significantly different from baseline. In the control group, there was no significant change of residual clearance during the observation period. Repeated measures ANOVA revealed no significant difference in the course of residual renal function between study and control groups. The decline of residual renal clearance between baseline and a routine visit after 4 months was comparable between groups. Correspondence and offprint requests to: Elisabeth Dittrich, MD, Division of Nephrology and Dialysis, Department of Medicine III, Medical University Vienna, Währinger Gürtel 18–20, A-1090 Vienna, Austria. Email: [email protected] Conclusion. Administration of iopromide did not lead to a persistent decline of residual renal function in CAPD patients. Nevertheless, non-ionic hypoosmolar CM should be given to these patients with the lowest possible dose and only if there is a real clinical indication. Keywords: angiography; iopromide; renal failure; residual diuresis Introduction Several recent studies have shown that residual renal clearance and peritoneal clearance of small solutes are not equivalent [1–3]. In peritoneal dialysis (PD) patients, there is a strong relationship between residual renal function and oral calorie intake [4], risk of infection [5], hospitalization [5], quality of life [6], hypertension [7], as well as left ventricular hypertrophy [8]. Furthermore, in contrast to peritoneal small solute clearance, residual renal clearance is a strong independent predictor of survival [1–3]. Therefore, it is essential to preserve residual renal function in dialysis patients as long as possible. Among the suggested prophylactic strategies are application of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers, use of biocompatible dialysis solutions, prevention of peritonitis and avoidance of nephrotoxic drugs such as aminoglycosides, non-steroidal antiinflammatory agents and radio contrast media (CM) [9,10]. Intravenous administration of CM may increase the risk of acute renal failure in non-dialysis patients, especially in those with impaired renal function [11,12]. Interestingly, several retrospective studies could not show any long-term influence of intravenous application of CM on the decline of residual renal function in PD patients or did not consider this aspect [13–16]. ß The Author [2005]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please email: [email protected] Radio contrast media and residual renal function In this prospective study, we investigated the effect of administration of CM on renal clearance in stable PD patients. Patients and methods Clinically stable continuous ambulatory peritoneal dialysis (CAPD) patients with residual renal function (defined as residual renal clearance >1.5 ml/min/1.73 m2) who underwent elective diagnostic intra-arterial or intravenous administration of contrast agents were included consecutively in the study group. Patients were older than 18 years and treated with PD for at least 2 months before inclusion. Iopromide (ULTRAVISTÕ , SCHERING-WIEN, Vienna, Austria; a iodinated, non-ionic hypo-osmolar CM) was used for all interventions. The decision on the amount of CM administered in the individual patient was based on clinical requirements. Exclusion criteria were congestive heart failure (ejection fraction <35%), clinical signs of dehydration, allergy against CM, hyperthyroidism, severe hepatic disease, systemic infection within 1 week before the start of the study, neoplasia without remission, poor patient compliance, change in ACE inhibitor dose and start of non-steroidal antiinflammatory drug therapy or therapy with nephrotoxic antibiotics within 1 week prior to screening. The primary end-point was the change of residual renal clearance within 1 month after contrast administration. To calculate renal clearances, each patient was asked to collect 24 h urine samples on the day before CM administration (baseline), as well as on days 1–7, day 10 and day 30 after the intervention. Blood samples (once daily) were taken at the same time points. No pre-medication (e.g. acetylcysteine or theophylline) or intravenous hydration was given before CM administration. However, patients were asked to maintain an oral fluid intake of 500 ml above the total of 24 h urine volume and 24 h peritoneal ultrafiltration to avoid negative fluid balance or dehydration. In the control group, patients (older than 18 years and clinically stable on CAPD for at least 2 months) without exposure to CM during the last 8 months before the study began were included consecutively in the order of the date of their routine control. Diagnostic procedures were the same in this group, including sampling of 24 h urine and blood on eight consecutive days (corresponding to baseline and day 1–7), on day 10 and on day 30. Additionally, values of residual renal clearance measured in patients of both groups during a routine visit 4 months after baseline were included in the final analysis. Blood and dialysate chemistry as well as blood cell count were performed using routine methods. Residual renal clearance (in ml/min) was calculated as the average of renal creatinine and renal urea clearance, using the PD adequest 2.0 programme (Baxter Healthcare Cooperation, Deerfield, IL) and normalized to 1.73 m2 body surface area. At baseline, as well as on days 1–7, 10 and 30, both patients in the study group and those in the control group underwent a clinic evaluation. During this visit, a physical examination, 24 h fluid balance (to ensure that all patients were euvolaemic) and blood pressure measurements were performed. The study protocol was approved by the Ethics Committee of the Medical University Vienna. Each patient gave written informed consent before inclusion in the study. 1335 Statistics Continuous data are presented as the median and the interquartile range (IQR, range from the 25th to the 75th percentile). Discrete data are given as counts and percentages. We used Fisher’s exact tests to compare proportions, and Mann–Whitney U-tests and Wilcoxon paired tests for univariate comparison of continuous data, as appropriate. Repetitive measurements within groups of continuous data were analysed by Friedman tests. Furthermore, we performed a repeated measures analysis of variance (ANOVA) defining the time and patient/control group as crossed fixed effects and the subjects nested in the group, and testing for interaction between group and time to assess a potential differential profile between study and control group. A two-sided P-value <0.05 was considered statistically significant. Calculations were performed with Stata (release 8.0) and SPSS for Windows (Version 10.0, SPSS Inc., Chicago, IL). Results Patient flow Twelve CAPD patients were included in the study group. There were two adverse events in two patients. These two patients dropped out because of hypertensive crisis without signs of hypervolaemia in one case and a severe bleeding complication at the puncture site complicated by secondary infection in the other. Therefore, 10 patients remained in this group for final statistical analysis. Eight CAPD patients were included in the control group. All eight patients completed the study. In none of the control patients have adverse events been reported. Baseline characteristics Underlying kidney diseases were chronic glomerulonephritis (n ¼ 2 in the study group and n ¼ 4 in the control group), diabetes (n ¼ 2 in the study group and n ¼ 2 in the control group), polycystic kidney disease (n ¼ 2 in the study group), chronic interstitial nephritis (n ¼ 2 in the study group), vascular nephropathy (n ¼ 1 in the study group) and end-stage renal disease of unknown origin (n ¼ 1 in the study group and n ¼ 2 in the control group). Co-morbid conditions were equally balanced in the two groups [Charlson co-morbidity index: patient group 4.5 (median; IQR 3.0–7.5) vs control group 4.0 (median; IQR 3.0–5.0), P ¼ 0.55]. Table 1 shows the patient characteristics. There was no significant difference in age, gender, duration of dialysis, prevalence of diabetes and hypertension, proteinuria, serum albumin, use of ACE inhibitors, angiotensin II receptor blockers, calcium channel blockers or diuretics, baseline urine volume and baseline residual clearance between the study group and the control group. None of the patients received non-steroidal anti-inflammatory drugs or nephrotoxic antibiotics within the observation period. There was no change in the PD protocol. Treatment volume was comparable between both groups. Three patients in each group 1336 E. Dittrich et al. Table 1. Demographic and clinical data of PD patients included in the study group and the control group Gender (F/M) Age (years) Body mass index (kg/m2) Diabetes mellitus n (%) Hypertension n (%) Duration of dialysis (months; median, IQR) Baseline residual renal function (ml/min/1.73 m2; median, IQR) Baseline urine volume (ml/day; median, IQR) ACE inhibitor/angiotensin II receptor blockers n (%) Calcium channel blockers n (%) Diuretics n (%) Serum albumin (g/l; median, IQR) Proteinuria (g/day; median, IQR) a Study group (n ¼ 10) Control group (n ¼ 8) P-value 4/6 62.5 23.5 2 9 12.5 5.5 1850 4 5 6 36.6 0.31 3/5 47.5 27 2 8 15.5 6.6 1650 6 5 5 36.6 0.98 0.99a 0.36b 0.99b 0.99a 0.99a 0.36b 0.41b 0.90b 0.19a 0.66a 0.99a 0.97b 0.17b (45.3–67.8) (21.0–28.8) (20%) (90%) (2.8–19.8) (2.9–8.1) (1050–2150) (40%) (50%) (60%) (34.2–39.3) (0.14–1.18) (45.3–63.3) (25.3–33.0) (25%) (100%) (11.3–26.0) (6.0–8.7) (1325–2025) (75%) (63%) (63%) (34.1–39.1) (0.25–1.71) Fisher’s exact test. Mann–Whitney U-test. b Reason for exposure to contrast medium 1 2 Coronary angiography Coronary angiography 3 4 5 6 7 8 9 Coronary angiography Coronary angiography Computed tomography of the kidneys Peripheral angiography þ PTA Coronary angiography þ PCI Coronary angiography þ PCI Coronary angiography 10 Coronary angiography Dose of iopromide (concentration of iodine) 60 ml 110 ml 45 ml 80 ml 60 ml 120 ml (370 mg/ml) (370 mg/ml) þ (300 mg/ml) (370 mg/ml) (370 mg/ml) (300 mg/ml) 190 ml 430 ml 150 ml 50 ml 45 ml 60 ml (300 mg/ml) (370 mg/ml) (370 mg/ml) (370 mg/ml) þ (300 mg/ml) (370 mg/ml) PCI ¼ percutaneous coronary intervention; PTA ¼ percutaneous transluminal angioplasty. performed one dialysate exchange per day with icodextrin. Table 2 displays the amount of CM applied and the type of intervention performed in the patients of the study group. Five patients received <100 ml of iopromide, four patients received 100–200 ml and only one patient received >200 ml. 14.0 Residual renal clearance (ml/min/1.73m2) Patient Individual course of residual renal clearance (study group) 12.0 10.0 8.0 6.0 4.0 2.0 0.0 baseline 1 2 3 4 5 6 7 10 30 Time interval (days) Individual course of residual renal clearance (control group) 14.0 Residual renal clearance (ml/min/1.73m2) Table 2. Reasons for exposure to iopromide, amount of contrast medium applied and concentration of iodine (in mg/ml) in PD patients 12.0 10.0 8.0 6.0 4.0 2.0 0.0 baseline 1 2 3 4 5 6 7 10 30 Time interval (days) Fig. 1. Serial data of residual renal clearance (in ml/min/1.73 m2) of each patient of the study group and of the control group. Residual renal clearance Figure 1 displays serial data of the residual renal clearance of each patient. The course of residual renal clearance for the two patient groups is shown in Table 3 (absolute values) and Figure 2 (differences from baseline). In the study group, there was a temporary decline of residual renal clearance after administration of iopromide. The lowest median level of renal clearances was reached on day 6 [3.78 ml/min/1.73 m2 (IQR 2.56–6.77 vs baseline 5.50 ml/min/1.73 m2 (IQR 2.91–8.10)] (Table 3). Thereafter, renal clearances increased again. On day 30, there was no significant difference in clearances as compared with baseline values. Using the Friedman test, there was a significant difference in the course of renal clearances in the study group (P ¼ 0.049, Figure 2). In the control group, there was no significant change of residual renal clearance between baseline and day 30. Radio contrast media and residual renal function 1337 Table 3. Peritoneal ultrafiltration, residual renal clearance (RRC) and urine volume in PD patients included in the study group (n ¼ 10) and the control group (n ¼ 8), presented as median and IQR (25th–75th percentile) Baseline Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 10 Day 30 Ultrafiltration (ml/24 h) RRC (ml/min/1.73 m2) Urine volume (ml/24 h) Study group Control group Study group Control group Study group Control group 210 425 700 790 715 775 645 540 600 425 865 895 925 965 845 870 935 770 850 960 5.50 5.50 4.48 5.03 4.72 4.45 3.78 4.50 4.64 4.76 6.64 5.67 5.52 5.99 5.73 5.58 5.71 6.52 7.11 5.16 1850 2025 1100 1375 1425 1250 1450 1150 1350 1500 1650 1520 1400 1460 1550 1550 1650 1775 1450 1350 (163–808) (98–710) (543–1215) (325–1260) (318–1270) (543–1285) (250–1305) (303–1250) (150–785) (85–904) Residual renal clearance Difference from baseline (ml/min/1.73m2) 5 (655–1040) (783–1045) (730–1095) (715–1120) (743–1085) (775–1110) (865–1175) (695–1275) (785–1120) (890–1310) (2.91–8.10) (3.38–7.62) (2.49–7.35) (3.12–6.47) (1.88–6.92) (2.25–6.64) (2.56–6.77) (2.88–5.90) (2.77–7.96) (2.89–5.81) study group control group p=0.049 p=0.82 (6.01–8.71) (5.01–9.46) (4.65–9.26) (4.93–8.76) (4.10–9.63) (4.84–8.34) (4.77–8.53) (5.15–7.87) (4.97–8.64) (4.62–8.80) (1050–2150) (1513–2238) (713–1750) (850–1700) (1100–1805) (1075–1825) (963–1638) (963–1800) (1213–1813) (1175–2238) (1325–2025) (1125–1888) (1013–1850) (1100–1950) (1188–1900) (1200–1838) (1175–2125) (1475–2063) (1250–2038) (825–1975) 4 3 2 1 0 −1 −2 −3 −4 −5 1 2 3 4 5 6 7 10 30 1 2 3 4 5 6 7 10 30 Time interval (days) Fig. 2. Residual renal clearance in PD patients (shown as difference from baseline in ml/min/1.73 m2) included in the study group (n ¼ 10) and the control group (n ¼ 8). The box plots indicate median, interquartile range and range. P was determined by the Friedman test. As an alternative to this non-parametric statistical approach, we used repeated measures ANOVA to assess a difference in the course of residual renal function in study and control group. However, we observed no significant difference in the course of residual renal function between patients and controls as indicated by the absence of a significant interaction between case/control and time interval (P ¼ 0.23). Nevertheless, inspection of the residuals showed a non-normal distribution, which could not be transformed to normal by logarithmic or squared transformation. Residual renal clearance 4 months after baseline was 4.48 ml/min/1.73 m2 (median; IQR 2.63–6.36) in patients of the study group and 4.89 ml/min/1.73 m2 (median; IQR 3.98–7.69) in control patients (P ¼ 0.48). There was no significant difference in the decline of residual renal function from baseline to 4 months between the two groups (P ¼ 0.89). Blood pressure control, peritoneal ultrafiltration and body weight None of the patients who completed the study had any change of blood pressure, number or dose of antihypertensive agents or signs of overhydration. Peritoneal ultrafiltration and urine volumes in both patient groups are shown in Table 3. In patients after CM administration, peritoneal fluid removal increased within the observation period. However, ultrafiltration tended to be larger in the control group as compared with the study group. The average ultrafiltration (day 1 to day 30) was 480 ml (median; IQR 394–1192) in the study group and 877 ml (median; IQR 705–1199) in the control group. This difference did not reach the level of significance (P ¼ 0.122, Mann–Whitney U-test). The average urine volume was 1382 ml (median; IQR 1010–2094) in the study group and 1565 ml (median; IQR 1151–2092) in the control group (P ¼ 0.965, 1338 Mann–Whitney U-test). There was no major change in body weight during the observation period (data not shown). Discussion Intravenous administration of CM is associated with acute renal failure in patients with impaired renal function [11,12]. The influence of intravenous CM on decline of residual renal function in dialysis patients is less well documented. Several studies have identified factors impairing residual renal clearance in dialysis patients, such as enhanced peritoneal ultrafiltration, increased dialysate treatment volumes, dehydration, large body mass index, untreated hypertension, high peritonitis rate, presence of cardiomyopathy, diabetes, marked proteinuria and use of aminoglycosides [13–18]. Some of these studies, however, did not consider the effect of intravenous administration of CM on renal clearances in their analyses [13,15,16,18]. In other retrospective analyses, administration of CM had no long-term influence on residual renal function in dialysis patients [14]. This is the first prospective study investigating the influence of CM on residual renal function in PD patients. We found a mild decline of renal clearance after administration of iopromide (a iodinated, nonionic hypo-osmolar CM) as compared with a control group. This effect, however, was temporary, with a minimum median level of renal clearances on day 6. Our results differ from those published in non-dialysed subjects, in whom the maximal increase of creatinine in the case of CM-associated nephropathy usually occurs within 72 h after injection [19,20]. The change of renal clearance was significant using the Friedman test, but we did not find a significant interaction between case/control and time interval in the repeated measures ANOVA. These differences might be explained by the non-normal distribution of the data set (normal distribution is ideally required for performing ANOVA, but not necessarily for analysis using Friedman test). However, a type II error cannot be excluded. Nevertheless, visual inspection of the data (Figure 2) suggests a moderate and temporary decline of renal clearances in the study group. There may be several reasons for the lack of a persistent effect of CM administration in PD patients. Apart from renal haemodynamic changes, direct tubular toxicity also plays a role in the occurrence of CM-associated nephropathy [19]. In dialysis patients, however, renal clearance of CM is reduced, and toxic levels in the renal tubular system may occur later and may be lower than in subjects with normal renal function. Secondly, the incidence of acute renal impairment depends on the amount of CM applied [12]. The dose of CM used in most of our patients was rather low. Only two patients received >160 ml of iopromide. In the study group, peritoneal fluid removal increased during the observation period. However, peritoneal ultrafiltration at baseline as well as average E. Dittrich et al. peritoneal ultrafiltration over the study period remained lower in the study group as compared with the control group. This difference did not reach the level of significance. Since patients did not change their PD regimen and continued to use the same glucose concentration as before the start of the study, the observed increase in ultrafiltration in the study group is probably explained by random variation. Increased peritoneal fluid removal is correlated with a more rapid decline of residual renal clearance. From this point of view, a decrease of residual renal clearance would be expected in the control group rather than in the study group. Considering this aspect as well as the fact that all patients were euvolaemic, the observed differences in ultrafiltration between groups most probably do not explain a decline in residual renal function after CM administration. There are some limitations to this study. Based on the presented data, we cannot draw conclusions about possible long-term effects (beyond 4 months) of intravenous injection of iopromide. The fact, however, that there was no significant difference between clearance values after 30 days and those at baseline makes such a long-term effect on residual renal function unlikely. Furthermore, the decline of residual renal clearance from baseline to 4 months was comparable between patients of the study group and those of the control group. The only marginal change of residual renal clearance observed in study patients in the present study may also explain why retrospective studies could not find any long-term effect of CM on residual renal function. Of course, it cannot be excluded that higher CM doses or repetitive short-term damage due to several CM applications (as necessary in some dialysis patients) may lead to a persisting decrease of renal clearance. The patient number in this study was rather small, because only those with elective CM application and good patient compliance (24 h urine sampling over several days) were included. We are aware of the shortcomings of an unadjusted analysis comparing such small sample sizes. Finding no significant differences in baseline characteristics between the groups certainly does not mean that these differences do not exist or are clinically irrelevant, e.g. imbalances between the use of ACE inhibitors or differences in average proteinuria, hypertension and amount of co-morbidity. Nevertheless, the small sample sizes do not allow us to perform adjusted multivariate analyses, and our results therefore have to be interpreted with some caution. However, the only temporary decline of residual renal clearance in the study group suggests an effect of CM and cannot be solely explained by differences in the above-mentioned baseline factors, which remained unchanged throughout the observation period. It was part of the study protocol that the same CM was used for all interventions. For ethical reasons, however, the decision on the amount of CM given had to be based on clinical requirements and was left to the physician who performed the investigation. Radio contrast media and residual renal function Therefore, the dose of iopromide differed between individual patients of the study group. Because of the small sample size, we did not correlate the dose of CM with the decrease in residual renal clearance. Finally, further studies are needed to clarify if the effect of iopromide on residual renal function found in our study is also transferable to other CM. In summary, administration of iopromide did not have a persistent effect on residual renal function in CAPD patients. However, the temporary decline observed during the first week after exposure to CM should be noted. The tremendous influence of residual renal clearance on the outcome of PD patients is undisputed. 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