RENAL DATA FROM THE ARAB WORLD
|Year : 2019 | Volume
| Issue : 2 | Page : 451-461
|Long-term clinical outcomes of peritoneal dialysis patients: 10-year experience of a single unit from Tunisia
Lilia Ben Lasfar, Yosra Guedri, Dorsaf Zellama, Imen El Meknassi, Awatef Azzebi, Sinda Mrabet, Asma Fradi, Salma Toumi, Ferdaous Sabri, Samira Ben Amor, Wissal Sahtout, Abdellatif Achour
Department of Nephrology, Dialysis and Kidney Transplantation, Sahloul Hospital, Sousse, Tunisia
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|Date of Submission||08-Jun-2018|
|Date of Acceptance||16-Sep-2018|
|Date of Web Publication||23-Apr-2019|
| Abstract|| |
Published data on the outcome of maintenance peritoneal dialysis (PD) since the initiation of PD in Tunisia is poor. The purpose of this study is to report long-term clinical outcomes of PD patients through a 10-year experience at a single unit. This is a retrospective review of the medical records of 182 PD patients who were followed up from January 2006 to June 2016. All patients were followed till death, renal transplant, switch over to hemodialysis (HD) or the end of the study in June 2016. The mean age of the incident patients was 43.93 ± 16.95 years. Nineteen (10.4%) were aged >65 years and 59.3% were male. The average duration of follow-up was 27.75 ± 26.18 months. The mean duration of PD treatment was 27.75 ± 26.18 months. There were 186 episodes of peritonitis that occurred over the total study period (54 episodes during the 1st year). The overall incidence of peritonitis during the 10-year study period was 1 per 27.25 patient months. Mechanical complications were noted in 31.2% of cases. Thirty- two (17.6%) patients had catheter displacement. Only 26 cases of hemoperitoneum (14.3%) were recorded. Death occurred in 23.1% of cases. Twenty-two patients (27.5%) were transplanted; 56 patients (70%) were transferred to HD, one patient had renal recovery and one case had voluntarily interrupted PD. In Kaplan–Meier curves of residual renal function (RRF) loss, there was a significant difference between peritonitis group and peritonitis-free group (P = 0.01). Technique and patient survival were associated with diabetes with a significant difference. The main cause of technique failure was peritonitis (61.4%). Moreover, the main repertoried causes of death were cardiovascular and septic causes. The mortality of diabetic and elderly PD patients was higher than mortality in nondiabetic and nonelderly groups, respectively, in our study. Peritonitis was associated with loss of RRF and technique failure.
|How to cite this article:|
Lasfar LB, Guedri Y, Zellama D, El Meknassi I, Azzebi A, Mrabet S, Fradi A, Toumi S, Sabri F, Amor SB, Sahtout W, Achour A. Long-term clinical outcomes of peritoneal dialysis patients: 10-year experience of a single unit from Tunisia. Saudi J Kidney Dis Transpl 2019;30:451-61
|How to cite this URL:|
Lasfar LB, Guedri Y, Zellama D, El Meknassi I, Azzebi A, Mrabet S, Fradi A, Toumi S, Sabri F, Amor SB, Sahtout W, Achour A. Long-term clinical outcomes of peritoneal dialysis patients: 10-year experience of a single unit from Tunisia. Saudi J Kidney Dis Transpl [serial online] 2019 [cited 2019 May 24];30:451-61. Available from: http://www.sjkdt.org/text.asp?2019/30/2/451/256852
| Introduction|| |
Peritoneal dialysis (PD), is a recognized treatment modality in patients with end-stage renal disease (ESRD). Close to 150,000 patients are being maintained on continuous ambulatory PD (CAPD) worldwide. Actually, the CAPD withdrawal has become common compared to hemodialysis (HD), even though several publications indicate that survival rates with PD are better than those with HD after three years from initiation,.
The patient outcomes with PD are comparabie to or better than those with HD, and PD is also more cost-effective. Because of this, use of this therapy is increasing in some countries, including China, the USA, and Thailand.
In Tunisia, PD use in the management of patients in end-stage renal failure was limited until the introduction of CAPD in 1976. In 1990, CAPD covered about 4% of renal replacement therapy patients and its cost was considerably lower than center HD.
Since then, interest in PD has increased tremendously, challenging HD as the first choice dialysis treatment in Tunisia. At our institute, we propose both the PD and HD according to the patient’s wishes and the contraindications for the respective dialysis modality. CAPD and automated PD (APD) were introduced at our center in 2006. The study reports a single-center experience and long-term clinical outcomes over a period of 10 years.
| Patients and Methods|| |
This was a retrospective analysis of all patients who were initiated on CAPD or APD at Sahloul Hospital in Sousse, Tunisia between January 2006 and June 2016. All patients were followed till death, renal transplant, switch to HD or the end of the study in June 2016.
All patients had surgical implantation under general or local anesthesia of two-cuff Tenckhoff straight catheters. Then, they were initiated on manual exchanges (CAPD). Switch to APD was done after the determination of peritoneal equilibration test.
Patients were advised to contact the treating nephrologist or nurse by telephone for any assistance. When peritonitis is suspected, patients were advised to consult the PD unit for microbiological analysis of peritoneal effluent and to receive treatment. If the patient remains far from the hospital and needs a delay before the consultation, he was advised to start the empiric antibiotics covering both Grampositive and Gram-negative organisms through an intraperitoneal route.
The data collected included at baseline (the start of dialysis therapy):
- Demographic and clinical data: age, sex, the presence of diabetes, hypertension, comorbidities, and residual renal function (RRF)
- Biochemical data: Levels of hemoglobin, serum albumin, cholesterol, calcium, phosphorus, ferritinemia, C-reactive protein, and normalized protein catabolic rate
- Ultrafiltration, types of antihypertensives, types of dialysate solutions.
During follow-up, the RRF was tested at the 1st month, 3rd month, at six months then every six months till the end-point study. Survival and complications related or unrelated to PD were reviewed.
The data were analyzed to determine PD outcomes in terms of peritonitis, mechanical complication, RRF, technique, and patient survival. Different subgroups were compared in the analysis of RRF, technique survival (diabetic and nondiabetic; peritonitis and non peritonitis cases) and patient survival (diabetics vs. nondiabetic, patients aged <40 vs. aged between 40–65 years and >65 years)
Peritonitis was defined as peritoneal effluent that contains >100 white cells/μL with polynuclear leukocyte count strictly superior to 50%.
Loss of RRF was defined as an RRF equal or <2 mL/min.
Technique survival was defined as the persistence of the technique used until permanent transfer to HD due to inadequate dialysis, peritonitis, ultrafiltration failure and mechanical or operational problems. For the analysis, the endpoint event was transferred to HD, whereas transplantation or death on PD was the censored observations.
Patient survival was defined as the probability of patients surviving on PD. The analysis of patient survival from any cause, death was the endpoint event, while switch to HD or transplantation were the censored observation.
Early death was defined as each death that occurred in the first six months after the beginning of PD.
| Statistical Analysis|| |
Descriptive statistics included means, standard deviation (SD), and percentages and was used to describe demographic and clinical data baseline.
The data were expressed as a mean ± SD for continuous variables and numbers (n) and percentages (%) for categorical variables.
The analyzed variables included sex, age, anuria, ultrafiltration, icodextrine use, comorbidities, biochemical data, and baseline PD adequacy.
RRF loss, curves of technique, and patient survival were performed with the Kaplan–Meier model.
A log-rank test was used to compare RRF, technique and patient survival between subgroups. A value of P <0.05 was considered statistically significant. All statistics were carried out using Statistical Package for the Social Sciences for Windows, version 20.0 (IBM Corp., Armonk, NY, USA).
| Results|| |
Baseline demographic and clinical characteristics
A total of 182 patients with ESRD were started on CAPD or APD during the period of 10 years. The mean age of the incident patients was 43.93 ± 16.95 years, nineteen (10.4%) were over 65 years old and 59.3 % were male. The average duration of follow-up is 27.75 ± 26.18 months.
One hundred and seven patients had a follow-up duration of >2 years. Thirty-six patients had a follow-up duration of more than four years. The baseline characteristics of 182 patients are shown in [Table 1].
|Table 1: Baseline demographic and clinical characteristics of the peritoneal dialysis patients (n=182).|
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The total follow-up was 5068.5 patient-months (422.38 patient-years) [Table 2]. The mean duration of PD treatment was 27.75 ± 26.18 months [Table 2].
|Table 2: Follow-up and long-term outcomes of the peritoneal dialysis patients (n=182).|
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Six patients had a history of renal transplantation. Fourteen patients were on HD before the beginning of PD. Ten cases (5.5%) were transferred from HD to PD due to the exhaustion of vascular access. Seven had stopped the PD technique but subsequently have successfully re-used the same technique again: One patient had interrupted PD and was transplanted, four patients stopped the technique because of ultrafiltration failure induced by peritonitis, one patient had a catheter displacement and in one, the cause was undetermined.
There were 186 episodes of peritonitis that occurred over the total study period (54 episodes during the 1st year). The group peritonitis-free represents 48.9% of the total population (n = 89). The overall incidence of peritonitis during the 10-year study period was 0.44 episodes per patient-year which equals 1/27.25 patient-months.
Mechanical complications were not common (31.2%) [Table 2]. Thirty-two (17.6%) patients had catheter displacement, but in only three cases, the displacement was responsible for transfer to HD. Otherwise, only 26 cases of hemoperitoneum (14.3%) were recorded [Table 2].
The majority (76.9%) of the long-term follow-up patients were alive. Twenty-two patients (12%) were transplanted; fifty-six patients (30.7%) transferred to HD, one patient had renal recovery and one case had voluntarily interrupted PD [Table 2].
Loss of residual renal function
During follow-up period, RRF continued to fall. Loss of RRF at 1 year, 2 years, 3 years, 4 years, and 5 years was 88.7%, 78.3%, 62.2%, 48.2%, and 33.5%, respectively [Figure 1].
|Figure 1: Global cumulative incidence of RRF loss.|
RRF: Residual renal function.
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Loss of RRF in diabetes group at 1 year, 3 years, and 5 years was 88.7%, 62.2%, and 33.5%, respectively. In peritonitis group, it was 88.7%, 62.2%, and 33.5% at 1 year, three years, five years also respectively.
In Kaplan–Meier curves of RRF loss, there was no difference between diabetic group and nondiabetic group [Figure 2], but there was a significant difference between peritonitis group and peritonitis-free group (P = 0.01) [Figure 3].
|Figure 2: Global cumulative incidence of RRF loss (diabetic group vs. nondiabetic group).|
RRF: Residual renal function.
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|Figure 3: Global cumulative incidence of RRF loss (peritonitis group vs. peritonitis-free group).|
RRF: Residual renal function.
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Technique survival at 1 year, 2 years, 3 years, 4 years and 5 years was 96.7%, 90%, 84.5%, 79.3%, and 73.9%, respectively [Figure 4]. Technique survival in diabetic group was lower than in nondiabetic group. It was 85.2%; 54.9% and 11.7% in diabetic group versus 91,7%; 77.3%, and 62.4% in nondiabetic group, respectively, at 1 year, 3 years, and 5 years. There was significant difference between the two groups (P = 0.014) [Figure 5].
|Figure 4: Kaplan–Meier overall technique survival of the peritoneal dialysis patients.|
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|Figure 5: Kaplan–Meier technique survival of diabetic versus nondiabetic peritoneal dialysis patients.|
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However, there was no difference between the peritonitis group and peritonitis-free group (P = 0.63) in Kaplan–Meier curve technique survival [Figure 6].
|Figure 6: Kaplan–Meier technique survival of peritonitis group versus peritonitis-free group in peritoneal dialysis patients.|
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Technique failure was not only correlated to infectious complications but also to mechanical complications. The major cause of switch to HD was certainly the occurrence of peritonitis (61.4 %). The other causes were ultrafiltration failure (24.56%), catheter dysfunction (5.2%), and catheter displacement (5.2%) [Table 3].
Patient survival at 1 year, 2 years, 3 years, 4 years and 5 years was 96.1%, 93.2%, 91.4%, 90.8%, and 89.3% respectively.
Patient survival in diabetic group was lower than that of nondiabetic group. It was 89.9%, 69.3%, and 22.2% in diabetic group versus 94.9%; 92.9%, and 88.5% in nondiabetic group, respectively, at 1 year, 3 years, and 5 years.
Hence, there was a significant difference in the Kaplan–Meier survival between diabetic and nondiabetics (P = 0.000) [Figure 7] and between the different age range: the group aged 65 years had the worst survival compared with the two groups aged <40 years and (≥40 years and <65 years) (P = 0.000) [Figure 8].
|Figure 7: Kaplan–Meier patient survival of diabetic versus nondiabetic peritoneal dialysis. patients.|
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The total number of deaths was 42 among 182 patients listed (23.1%). Only 16 causes of death were identified. The cause was unknown for other cases: myocardial infarction (3), stroke (4), acute pulmonary edema of the lungs (3), septic causes (a jejunal perforation, a pneumopathy and peritonitis) (3) and cardiac arrest with undetermined causes (3). The mean age of patients with unknown cause of death is 55, 33 ± 18.25 years range (15–82 years).
We also reported 19 early deaths. Moreover, there was neither correlation between early death and age range (P = 0.43) nor diabetes (P = 0.87).
| Discussion|| |
Although kidney transplantation is the preferred treatment method for patients with ESRD, most patients are placed on dialysis either while awaiting transplantation or as their only therapy. Actually, the number of patients under PD is increasing, in Tunisia and our study was aimed to investigate the overall outcomes of PD patients during a follow-up period of 10 years.
Comparing with the Indian retrospective study of 80 ESRD patients who were initiated on CAPD between October 2002 and June 2011 (9 years follow-up period), our rate of alive recipients and transplant recipients were better (76.9% vs. 30%, 27.5% vs. 3% respectively); as also the HD transfer rate that was higher (38.4 % vs. 30%). In this paper, the authors had not listed the causes of transfer to HD, but we can explain our higher rate of transfer by our higher rate of peritonitis (0.44 per patient year in our study versus 0.39 per patient year in the Indian study.
Indeed, this peritonitis rate in our center (0.44 episodes per patient-year or one per 27.25 patient-month) was lower than those reported in previous studies. In Scotland, in a study including 10 adult renal units and 1205 patients, the overall peritonitis rate was one every 19.2 patient-months. The Renal Association standard recommends one episode every 18 months, and the International Society for Peritoneal Dialysis Guidelines consider the peritonitis rate of 0.67 per year acceptable. But the incidence of peritonitis varies greatly from unit to unit, and the incidence can reach one episode/73.5 patient-months. This Japanese rate is much better than our peritonitis rate.
Mechanical complications in our center were catheter displacement and hemorrhagic complications, 17.6% and 14.3%, respectively. Our results are partially similar to those of Flayou et al. This observational study was carried out in 89 patients with ESRD undergoing CAPD in Morocco Rabat. Indeed, this Moroccan series, catheter migration was the most common complication (36.8%), followed by obstruction (14%), dialysate leaks (14%), hemorrhagic complications (10.5%) and, finally, catheter perforation (5.2%)
In terms of loss of RRF, our results showed a significant difference between peritonitis group and peritonitis-free group (P = 0.01) in the Kaplan–Meier curves of RRF loss and no difference between diabetic and nondiabetic groups. These results are consistent with the literature on this topic. Caravaca et al, reported that diabetes, high body mass index (BMI) and high-level protidemia at baseline were related factors to a faster decline of RRF. Furthermore, Singhal et al, showed in their prospective study (including 242 patients starting continuous PD between January 1994 and December 1997) that higher rate of peritonitis, presence of diabetes mellitus, larger BMI were associated with faster decline of RRF.
In our study, infectious complication was the main cause of technique withdrawal. The major cause of switch to HD was peritonitis (61.4 %). The other causes were ultrafiltration failure (24.56%), catheter dysfunction (5.2%) and catheter displacement (5.2%). In the literature, the same causes were listed but rates varied from our results. Peritonitis remained the major reason of PD withdrawal. Indeed, Mizuno et al, in their Japanese study conducted on 357 patients, showed that PD-related peritonitis (excluding cases with gastrointestinal perforation or necrotizing appendicitis) as cause of technique failure tended to decrease from 24.7% in the first study period (2005–2007) to 23.2% in the second and last period (2010–2012) but remains as the major cause of technique failure. Similar to our study, ultrafiltration failure in this Japanese series became in second position (22% in the first follow up and 20% in the second follow-up). Withdrawal due to “social problems” clearly increased to 19.0% and appear as an important listed cause of technique failure.
Peritonitis remains the major cause of technique failure in a Korean study (63.6%). In a previous study in Scotland, Kavanagh et al, reported that the most common cause of technique failure in PD was reported to be peritonitis, followed by poor dialysis, failed peritoneal access, wish to transfer to HD, complications of high intra-peritoneal pressure, poor ultrafiltration , and cessation of dialysis.
In the United States, the Choices for Healthy Outcomes in Caring for ESRD (CHOICE study) reported infections complications as the leading reason for transferring from PD to HD, followed by cardiovascular factors (fluid overload) and abdominal surgery, pancreatitis/malnutrition, decreased mental capacity.
In Spain also, peritonitis was the main reason for transfer to HD from PD, followed by ultrafiltration problems, insufficient dialysis or problems related to the catheter. Thus our study confirms the previous reported finding that peritonitis is a leading cause of technique failure in PD. Others causes were listed too: gastrointestinal bleeding and perforation (5%), ischemic heart disease (3%) and mechanical complications (4%).
Mizuno et al, compared groups in technique failure. After further analysis, they showed that the nondiabetic group had better technique survival than diabetic one (P = 0.027).
In our series also, technique survival of non-diabetic group was significantly higher than the diabetic group (P = 0.014). But there was no difference between the peritonitis group and peritonitis-free group (P = 0.63), in Kaplan–Meier curves technique survival. This may be explained by the fact that the difference in technique survival between diabetic patients and nondiabetic is also related to nutritional status. Indeed, technique failure was more prominent in diabetic patients with a good nutritional status than in nondiabetic patients with a poor nutritional status in a Korean study conducted by Lee et al.
Technique survival was evaluated in our cohort at 1 year, 2 years, 3 years, 4 years and 5 years to be respectively 96.7%, 90%, 84.5%, 79.3% and 73.9%. Our study seems to be among the longest outcome study reported from our country and the technique survival rates were higher than those reported in previous studies. Lee et al, reported in a multicenter study technique survival rates of 96.8% and 89.3% in 311 PD Korean patients.
Concerning patient survival, over the last 10–15 years, as overall survival of dialysis patients has steadily improved, and statistical methods to analyze observational data have evolved, a pattern of virtual equivalence in survival among patients on HD versus PD and on CAPD versus APD has emerged.
In our study, patient survival at 1 year, 2 years, 3 years, 4 years, and 5 years was 96.1%, 93.2%, 91.4%, 90.8%, and 89.3%, respectively. These rates seem to be lower than that reported in other studies. In other countries, Prasad et al, reported patient survival at 1, 2, 3, 4, and 5 years of 90%, 72%, 60%, 49%, and 39%, respectively and Abraham et al reported patient survival of 87%, 82%, 72%, 45%, and 19%, respectively at 1, 2, 3, 4, and 5 years.
The leading cause of ESRD in our study was diabetic nephropathy (35.1%), similar to the studies by Prasad et al and Lee et al. The majority of reports agree that patient survival is lower in diabetics compared to nondiabetics. Prasad et al, found that patient survival was inferior in diabetics compared to nondiabetic patients on CAPD. Mujais and Story had reported that PD patients with diabetes have a 30% increased risk of death, compared to nondiabetic.
In this study, the survival was inferior and mortality was higher in diabetics compared to nondiabetics and in the group aged ≥65 years compared to the two groups aged <40 years and (≥40 years and <65 years), the differences were statistically significant. The major cause of mortality in our patients was cardiovascular, followed by infection, similar to what was reported by Prasad et al. Gray et al found that there was a trend toward increased cardiovascular and malignant deaths in rural areas. Cardiovascular diseases are the most common comorbidities and the most common causes of mortality in ESRD patients. Other authors reported infection as major cause of death in PD patients. In a Chinese study, Qianying Zhang et al, affirmed that the first cause of death in both males and females was sepsis with the percentages of 41.4% and 37.4% respectively.
| Conclusion|| |
The strengths of this study include its larger sample size and long follow-up time. However, the present study has several limitations. First, the database used provided limited information on sociodemographic characteristics and its impact on technique and patient survival.
The study reports on long-term outcomes of PD patients who were in majority diabetics. The mortality of diabetic versus nondiabetic and the elderly versus nonelderly PD patients was higher in the two groups, respectively, in our study. Peritonitis was associated with the loss of RRF and technique failure in these patients.
Good results can be achieved in PD with a satisfactory rate of survival by carefully selecting patients who have sufficient resources and can adhere to the basic rules of asepsis. With good medical care and assistance, it is a safe, viable mode of renal replacement therapy for ESRD patients.
Conflict of interest: None declared.
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Lilia Ben Lasfar
Department of Nephrology, Dialysis and Kidney Transplantation, Sahloul Hospital, Sousse
[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8]
[Table 1], [Table 2], [Table 3]
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