|Year : 2020 | Volume
| Issue : 1 | Page : 44-52
|Comparison of the effect of linear and step-wise sodium and ultrafiltration profiling on dialysis adequacy in patients undergoing hemodialysis
Mehri Hamidi1, Fariborz Roshangar1, Hamid Tayebi Khosroshahi2, Mansour Ghafourifard1, Parvin Sarbakhsh3
1 Department of Medical Surgical Nursing, Faculty of Nursing and Midwifery, Tabriz, Iran
2 Kidney Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
3 Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
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|Date of Submission||26-Aug-2018|
|Date of Decision||07-Oct-2018|
|Date of Acceptance||09-Oct-2018|
|Date of Web Publication||3-Mar-2020|
| Abstract|| |
Patients with chronic renal failure undergoing hemodialysis (HD) need to receive adequate dialysis. Dialysis inadequacy leads to an increase in the side effects and even frequent hospitalizations as well as increased therapeutic costs. Considering the fact that improving the adequacy of dialysis is one of the goals of nursing care in these patients, this study aimed to compare the effect of linear and step-wise sodium-ultrafiltration (UF) profiling on HD adequacy. This study is a clinical trial; a total of 32 patients from two dialysis centers in East Azerbaijan province were selected and randomly divided into two groups. Each patient underwent HD for three sessions by routine method, three sessions by linear sodium profile and UF, and three sessions by the step-wise sodium profile and UF. At the end of each HD method, Kt/V was calculated to determine the adequacy of dialysis. Data analysis was performed using Statistical Package for the Social Sciences software version 13 with generalized estimating equation statistical test. According to the results of this study, there was a statistically significant difference between the mean of adequacy of dialysis (Kt/V) in the three treatment methods (P <0.05), in which the mean score of dialysis adequacy in step-wise method was 0.14 more than the routine method, and in the linear method, it was 0.21 more than the routine method. The mean Kt/V scores were 1.24, 1.31, and 1.10 in the step-wise method, linear method, and routine method, respectively(P <0.05). The results of this study indicate that simultaneous application of sodium and UF profiles is effective in the hemodynamic stability of patients, which reduces uncomfortable complications during dialysis. Therefore, in order to improve dialysis adequacy and prevent the complications, usage of sodium and UF profiles is recommended.
|How to cite this article:|
Hamidi M, Roshangar F, Khosroshahi HT, Ghafourifard M, Sarbakhsh P. Comparison of the effect of linear and step-wise sodium and ultrafiltration profiling on dialysis adequacy in patients undergoing hemodialysis. Saudi J Kidney Dis Transpl 2020;31:44-52
|How to cite this URL:|
Hamidi M, Roshangar F, Khosroshahi HT, Ghafourifard M, Sarbakhsh P. Comparison of the effect of linear and step-wise sodium and ultrafiltration profiling on dialysis adequacy in patients undergoing hemodialysis. Saudi J Kidney Dis Transpl [serial online] 2020 [cited 2020 Apr 4];31:44-52. Available from: http://www.sjkdt.org/text.asp?2020/31/1/44/279960
| Introduction|| |
Chronic renal failure (CRF) is one of the chronic and prevalent diseases in modern societies, which refers to the progressive and irreversible loss of kidney function. When the kidneys are only working at 10%-15% of their normal rate, renal replacement therapies (RRTs) will be required. RRTs include hemodialysis (HD), peritoneal dialysis, and kidney transplantation, which attempt to compensate for the failure of the kidneys’ normal func- tioning. One of the most commonly used methods is HD. HD is a safe way for removing waste products, excessive potassium, urea, and extra water from blood.
About 10% of the world’s populations are suffering from chronic kidney disease (CKD), and millions of people die from this chronic disease due to lack of access to treatment. The number of patients with end-stage renal disease (ESRD) in the world is estimated to be around 3730,000 by the end of 2016. Considering the annual growth of approximately 5% to 6% of ESRD patients worldwide and the ever- increasing population of the world, this disease is one of the most important medical problems in the world. At the end of 2016, the number of dialysis patients is estimated to be around 2989,000 in the world, of which approximately 89% is treated by HD. According to the latest annual report of US information systems, more than 660,000 Americans with ESRD are being treated, of which 468,000 are receiving dialysis.
In Iran, the average prevalence of CRF is 680 people per one million, which is more than the global average, and more than 95% of these patients are receiving HD. It is estimated that the global growth of dialysis population will reach four million by 2020.
Although HD is considered a reliable method, it could have some adverse complications. These complications are attributed to the physiological changes induced by HD. The studies carried out in this field indicate that the physiological effects of dialysis such as hypotension, nausea, vomiting, and muscle cramp trigger disturbance in the patient’s comfort, and other problems such as intolerance in these patients. Current guidelines recommend that attempts should be made to minimize side effects and complications during dialysis, jeopardizing the dialysis adequacy.
Among the methods recently used to prevent dialysis complications is making changes in the concentration of sodium dialysate (sodium profiling) and the rate of fluid removal [ultrafiltration (UF) profiling]. In sodium profiling, a hypernatremic is used at the beginning of the dialysis session (i.e., when blood urea concentration and urea removal rates are high) and during the treatment course, the dialysate concentration of sodium is automatically decreased to prevent the accumulation of excessive sodium (which has been transferred to the patients during the hypernatremic period). The advantages of this method are that the use of high concentration of sodium at the beginning of the HD session facilitates the transfer of water from the intracellular space to the intravascular space and prevents hypotension and muscle cramps by maintaining intravascular volume.,
UF profiles are usually used to extract a larger portion of the total UF volume in the first part of the HD session, in which the patient has the most fluid in the blood vessels. This is carried out in order to increase the oncotic pressure of the plasma and provide a greater stimulus for vascular filling. Reducing the UF rate at the final stages of dialysis can help prevent complications. According to the studies, a combination of sodium profiles and UF could lead to better management and prevention of HD complications. Technological advancements and equipped dialysis machines have the advantage of altering sodium and UF concentrations according to linear and step- wise models.
The most effective method for analyzing the efficiency of HD in health and medical services, is to assess the adequacy of HD. Dialysis adequacy is a measure of how well the dialysis is working. Assessing the adequacy of dialysis provides the appropriate background for effective planning by health authorities. Considering the impact of dialysis adequacy on the quality of life and survival rates as well as the cost of medical health care, precise attempts should be made to achieve the desired goals. Identifying the effective factors is important in improving the adequacy of dialysis and how to increase this adequacy as well.
Despite significant advances in the management of medical sciences and dialysis treatment, the incidence and mortality rate in these patients has not significantly changed in the last 20 years and is unacceptably high. As one of the factors reducing the quality of life of these patients is the recurrence of hospita- lization and increased mortality of these patients due to inadequate dialysis, measures to increase the adequacy of dialysis are beneficial.
The most common methods for assessing dialysis adequacy are the urea reduction rate (URR) and the Kt/Vstandard. However, Kt/V is a more accurate method than the URR. According to the guideline, Kt/V >1.2 is an indicator that HD is adequate. According to the studies, mortality rate is reduced at 0.7%- 1.2%/0.1 increases in Kt/V, and mortality rate is reduced up to 11%/5% increase in URR.
HD session is usually managed by the HD nurse. The nurses are responsible for regulating the duration of dialysis, dialysis solution temperature, the flow of dialysis fluid, regulating blood circulation, choosing the type of sodium profile and the UF profile, the type of filter and the dialysis solution, priming and preventing and controlling the complications during HD, as well as measuring the adequacy of dialysis.
Considering the increasing number of patients with ESRD and selecting HD as the preferred treatment for these patients, attention to the importance of dialysis adequacy in survival and quality of life in HD patients is valuable. The duties of nurses working in the HD unit as health-care provider, are to provide quality health-care services and control the complications during HD. Although in previous studies, the benefits of using profiles to control complications during dialysis have been assessed and emphasized, there is still debate about the effects of profiles and the advantages and disadvantages of using them, and fewer studies have been conducted on the effect of profiles on the dialysis adequacy. Moreover, in the context of our HD centers, the profile of sodium and UF is not used routinely. Therefore, this study aimed to compare the effect of linear and step-wise profiles of sodium and UF on the adequacy of HD in patients with CRF undergoing HD.
| Methods|| |
This is a single-blind, crossover clinical trial. Participants of this study were HD patients who satisfied the inclusion criteria and referred to the two HD centers in the East Azerbaijan province of Iran.
The inclusion criteria were as follows: suffering from CRF, history of at least three months of dialysis, routine HD three sessions per week and a maximum of 4 h with sodium bicarbonate solution and anticoagulant heparin using Fresenius 4008S or 4008B (Fresenius Medical Care AG & Co, Bad Homburg, Germany )equipped with profile, age from 18 to 80 years and having arteriovenous fistula or central venous catheter, and not having any acute illnesses and hemoglobin <8 mg/dL. Exclusion criteria were as follows: patients with cardiac arrhythmias during HD or patients whose HD was discontinued and those with severe hypotension (<80 systolic mm Hg). In this study, all the 32 patients completed the study and no patients were excluded from the study.
After obtaining relevant permissions from Tabriz University of Medical Sciences, all participants entered the study after obtaining informed consent. A total of 32 patients were selected by convenience sampling method and then randomly divided into two groups of 16 patients. The demographic characteristics of the patients were extracted based on their demographic information. The patients underwent HD according to the following phases according to the proposal of previous studies.,
The first group underwent dialysis by routine method (constant dialysate sodium on 138 mmol/L), linear sodium-UF profile method, and step-wise sodium-UF profile method.
The second group included step-wise sodium- UF profile method, linear sodium-UF profile method, and routine method.
Each patient underwent HD for three sessions with each of the methods (a total of 9 sessions for each patient). In the routine method, the amount of sodium dialysate did not change, and from the first to the end of the HD, it was adjusted to 138 mmol/L. Moreover, the UF rate was also constant during the dialysis session. In the linear profile, sodium dialysate started from 146 mmol/L during the 1st h of treatment, and then gradually decreased every hour by linear model until it reached 138 mmol/L in the end of dialysis, and the UF rate was also linearly deducted. In the step-wise sodium and UF profile, the concentration of sodium dialysate was 146 mmol/L at the beginning of dialysis and then decreased by step-wise model and automatically reached 138 mmol/L and the rate of UF also decreased in the step-wise model. In this study, in order to control the confounding factors such as age, gender, and history of the disease, each of the patients was considered as self-control, and there was no washout between each method according to other previous studies. At the end of each treatment (3 sessions in each method), in order to calculate the dialysis adequacy, the blood urea nitrogen (BUN) and creatinine (Cr) blood samples were taken at the beginning of the last dialysis session before the injection of heparin through the arterial line. At the end of the session, BUN and Cr blood samples were again taken from the same line 1-2 min after the pump rate was reduced to 80-50 mL/min. The samples were sent to the laboratory where a laboratory expert analyzed them with a classical auto analyzer machine using a Pars Azmoon kit(Pars Azmun Karaj, Alborz 3197996511, IR). Based on the results of the tests and dialysis coordinates, the Kt/V values were calculated according to the following formula: Kt/V = - ln (R- 0.008 χ t) + ([4 - 3.5 χ R] χ [UF - W]).
Meanwhile, Kt/V was extracted one month earlier (which is recorded according to a country routine for all patients at the end of the month), and then the results of all the three treatments were compared with each other.
For all patients, the Fresenius 4008S or 4008B machine, made in Germany, equipped with sodium and UF profiles, was used; the type of solution was bicarbonate; the flow rate of dialysate solution was 500 mL/min; and the temperature was adjusted between 36.5°C and 37°C. Considering the patients’ clinical conditions, blood flow rate was between 250 and 300 mL/min, and all parameters were the same for a patient in each method of dialysis. The data were collected and analyzed by using the Statistical Package for the Social Sciences (SPSS) software version 13.0 (SPSS Inc, Chicago, IL, USA).
| Results|| |
A total of 32 patients undergoing HD, including 10 women (31.2%) and 22 men (68.8%), participated in this study. The mean age of the patients was 61.21 ± 10 years; the mean duration of HD was 49.84 ± 67 months (the minimum and maximum duration of HD were 4 and 264 months, respectively). Twenty-four patients (75%) were living in city and eight patients (25%) were living in village. In terms of family history, about three patients (9.4%) had a familial history of dialysis [Table 1]. In terms of the etiology of ESRD, diabetes and hypertension were the most common causes leading to ESRD [Table 2].
In this study, 144 HD sessions were analyzed in each group. Overall, 288 HD sessions were analyzed. The type of dialysis machine was Fresenius 4008B in 159 sessions (55.2%) and Fresenius 4008S in 129 sessions (44.8%). All the patients underwent HD three times a week and had a maximum HD time of 4 h. The lowest level of hemoglobin in the patients was 9.00 and the highest was 15.7, and the mean of hemoglobin was 11.7 mg/dL. The blood flow rate was chosen in the range of 250 to 300 mL/min. The vascular access was arterio- venous fistula in 21 (65.6%) patients and catheters in 11 patients (34.4%).
Of the 288 HD sessions in this study, HD complications were observed in 50 sessions (17.6% of the sessions). The incidence proportion of complications in the routine method was more than the other two methods (44%), and in the step-wise profile method, the incidence of complications (26%) was less than that of the linear profile method (30%). The most commonly occurred complication was hypotension (64%).
The mean score of Kt/V of patients one month before the study did not differ between the two groups, and 21.9% (7 patients) had proper adequacy and 78.1% (25 patients) had inadequate dialysis.
The results of the GEE test showed that after studying the effects of the group and course and method in terms of the Kt/V standard, the effect of the group was not statistically significant (P = 0.22), but the effect of the course (P = 0.003) and the effect of the treatment method (P <0.001) were statistically significant. There was a statistically significant difference between the mean of adequacy of dialysis (Kt/V) in the three treatment methods (P<0.05), and on an average, the mean score of dialysis adequacy in step-wise method was 0.14 more than the routine method, and in the linear method, it was 0.21 more than the routine method. The mean Kt/ V scores were 1.24, 1.31, and 1.10 in the step-wise method, linear method, and routine method, respectively, and the result of ANOVA test showed a statistically significant difference between them (P <0.05) [Table 3].
|Table 3: Comparison of the adequacy of dialysis scores (Kt/V) between three methods using ANOVA test.|
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Comparison of the mean score of Kt/V between pairs (routine and linear, routine and stepwise, and linear and stepwise) using paired t-test showed that the mean Kt/V scores in sodium and UF profiles (both linear and step- wise) were more than those of routine (P <0.05), but there was no specific superiority between the two types of profiles (P >0.05) [Table 4]
|Table 4: Comparison of mean score of Kt/V between pairs (routine and linear, routine and stepwise, and linear and stepwise) using paired t-test.|
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| Discussion|| |
Inadequate dialysis is responsible for the high mortality rate of patients with ESRD. The inadequate dialysis may cause some complications such as malnutrition, nausea and vomiting, anorexia, hypoalbuminemia, insomnia, hypertension, restless legs syndrome, and electrolyte imbalance, and all these complications reduce the quality of life of patients and even lead to death. Therefore, measures to increase the adequacy of dialysis can be a major step in improving the quality of life of HD patients. The results of this study indicate that the use of sodium and UF profiles can increase the HD adequacy more than the routine method. In this study, the means of Kt/V were 1.10, 1.24, and 1.31 in the routine, step-wise, and linear methods, respectively.
A study was conducted by Song et al in South Korea on HD patients who had hypotension more than 30% of the sessions. The results showed that sodium profiling alone was not a suitable treatment option and, when it was combined with UF profiles, the inci-dence of dialysis inadequacy (failure of the HD session) was reduced. The HD inadequacy in this study was defined as: ending the session before 75% of the scheduled time and failure to reach the desired UF and Kt/V <1.1.
Therefore, the authors concluded that the combination of sodium and UF profiles is a better option that guarantees dialysis quality without the complications associated with sodium increase. This study is similar to the current study in terms of simultaneous use of sodium and UF profiles as well as investigating HD adequacy, with the difference that it is, in general, dealing with dialysis inadequacy.
In another study by Salehi et al, which aimed to investigate the effect of sodium and UF step-wise profile on the adequacy of dialysis, the researchers concluded that sodium and UF step-wise profile has a significant effect on reducing the complications during dialysis and improves the quality of dialysis. In the absence of complications, dialysis is well tolerated by patients, which could help to increase the adequacy. As a result, the combination of sodium and UF profiles is recommended. The results of this study are consistent with the findings of the current study.
Ghafourifard et al compared the effects of the combination of linear and step-wise sodium and UF profiles on systolic and diastolic blood pressure changes of 26 patients and concluded that the use of profiles is a simple method that results in hemodynamic stability and reduces complications as well; therefore, the researchers have proposed the use of these methods rather than the routine method. In this study, like the present study, sodium dialysis fluid started from 146 mmol/L in the profile method and eventually reached 138 mmol/L as linear or stepwise, and sodium fluid in the routine method of concentration of sodium dialysis solution remained fixed as 138 mmol/L. The results of this are consistent with the findings of the current study.
Meira et al investigated the comparison of two types of sodium profiles (linear and step- wise) on the complications during dialysis in 22 patients in Brazil. The results showed that the incidence of hypotension and muscle cramp in the linear and step-wise profile groups was lower than that of the conventional method. In this study, like the previous study, the concentration of sodium dialysate started from 147 mmol/L in the profile method and reached 138 mmol/L as linear or stepwise, but sodium dialysis fluid was adjusted to 139 mmol/L in the standard method. The findings of this study are also consistent with the results of the present study, i.e., with a decrease in the incidence of complications, dialysis tolerance is improved and dialysis is fully performed; however, the adequacy of dialysis has not been evaluated.
In a study by Hamzi et al in Morocco on 14 patients, which was conducted to find out whether the use of sodium profiles with and without UF profile had no positive effects on the incidence of hypotension during dialysis, three dialysis models were used including routine dialysis, dialysis only with linear sodium profile, and dialysis with linear sodium and UF profile. The results showed that the use of profiles did not affect the reduction of intermittent HD; however, achieving the target UF in treatment with sodium and UF profile was higher than the routine method, but this level was significantly lower in treatment with sodium profiles than the routine method. However, the Kt/ V was similar in the three phases of the study, and the inconsistency of the results of this study is probably due to the sodium concentration in the profile method, which ranged from 147 to 131 mmol/L and the low-flux filter used in all sessions. Furthermore, online clearance monitoring (OCM) was used to measure Kt/V, while the result of a study showed that the OCM method provides a lower assessment of adequacy of dialysis.
| Strengths and Limitations|| |
This study has some strengths and limitations. In this study, we tried to select a large number of sample size as compared with previous studies. We selected 32 patients, whereas in some previous studies, the sample size was <30 patients.,,, Moreover, the sodium dialysate at the beginning of dialysis was 146 mmol/L which reached to 135 mmol/L at the end of dialysis. This range of sodium dialysate was near to the normal range of sodium in the body (135-145 mmol/L), whereas in some studies, the sodium dialysate was more than 150 mmol/L at the beginning of dialysis., In some studies, only one type of sodium and UF modeling has been studied, whereas we combined two types of sodium and UF models.
In this study, we applied each method on three dialysis sessions, and this is the limitation of the study. Therefore, using sodium and UF profiling in more than three sessions is recommended.
| Conclusion|| |
The results of this study indicate that simultaneous application of sodium and UF profiles is effective in maintaining the hemodynamic stability of patients, which reduces uncomfortable complications during dialysis. Therefore, the patient can completely tolerate dialysis, which results in better clearance of the toxins and the rate of the target UF is achieved, and as time is also effective in Kt/V, in order to increase the adequacy of dialysis and prevent complications, the usage of sodium and UF profiles with the selection of sodium in normal range in blood vessels is recommended instead of the routine method in most monthly sessions of the patient. Applying profiles is a simple method whose clinical use by nurses can improve the clinical condition and comfort of these patients and help reduce nursing interventions during HD. However, studies are recommended to be conducted with more sessions and control between sessions.
| Acknowledgments|| |
The authors are grateful to the vice-president of Tabriz University of Medical Sciences and the nursing staff of dialysis centers and the dialysis patients who participated in this study and helped us to do this project. This study was registered in the clinical trial site with registration No. IRCT2017080929090N3.
Conflict of interest: None declared.
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Department of Medical Surgical Nursing, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz
[Table 1], [Table 2], [Table 3], [Table 4]
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