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Biomedical subjects

N W Levin

Publications and source records attributed to N W Levin.

At least 19 recordsLinked to original sources
PubMed1999

An overview of the National Kidney Foundation-Dialysis Outcomes Quality Initiative Implementation.

Rigorously developed clinical practice guidelines have the potential to improve outcomes and favorably alter practice patterns. Because of widespread community concerns over the quality of dialysis care, the National Kidney Foundation initiated a Dialysis Outcomes Quality Initiative (NKF-DOQI) in March 1995 in an effort to create evidence-based best-practice clinical guidelines. Independent interdisciplinary Work Groups reviewed the available body of scientific literature on four selected topics: hemodialysis adequacy, peritoneal dialysis adequacy, vascular access, and anemia. More than 11,000 publications were identified, of which 1,500 were considered relevant and were subjected to structured review. Draft guidelines, with supporting rationales of their evidentiary basis, were subjected to a three-stage public and organizational review process. The final guidelines were issued in the fall of 1997. Because the potential benefit of guidelines depends on their implementation, planning for the implementation of NKF-DOQI was begun simultaneously with its review process. A 3-year implementation plan, with specific priorities and estimated costs, was developed and set into action by the end of 1997. The main objectives of the rather diverse and multifaceted plan of action are translating the NKF-DOQI Guidelines into clinical practice, building on what has been accomplished, and continued evaluation and review of the Guidelines.

Evidence-Based Medicine↗
PubMed1999

Development of a new approach to vascular access.

Three modes of access for hemodialysis (HD) have been available for over 20 years, the native arterial to venous (A-V) fistula, the polytetrafluorethylene (PTFE) graft fistula, and the central venous catheter. Overall, vascular access remains the single most costly source of morbidity and hospitalization in HD patients, indicating a severe need for improvement in this area. A significant contributor to access morbidity is the HD catheter, which protrudes through the skin and is subject to frequent infection. Subcutaneous ports have been developed to overcome this problem with catheters, but their application to HD has been elusive for 2 reasons, the use of a degradable septum that becomes vulnerable to infection with the use of large bore needles and the presence of a nonlinear flow path which produces damage to blood cells and stimulates thrombus formation at the required high flow rates. A new device, the Dialock, overcomes these objections by its use of a mechanical valve that maintains a linear flow path without directly contacting the blood. Results of a pilot study with 23 patients demonstrated a 78% cumulative survival rate after 1 year with a reduced rate of infection compared to catheters and sustained blood flow of 330 ml/min. The device represents a most promising advance in vascular access.

Arteriovenous Shunt, Surgical↗
PubMed1999

Validation of haemodialysis recirculation and access blood flow measured by thermodilution.

BACKGROUND: Recirculation (R) and access blood flow (Qac) measurements are considered useful indicators of adequate delivery of haemodialysis. It was the purpose of this study to compare measurements of R and Qac obtained by two different techniques which are based on the same principle of indicator dilution, but which differ because of the characteristics of the injection and detection of the different indicators used. METHODS: Recirculation measured by a thermal dilution technique using temperature sensors (BTM, Fresenius Medical Care) was compared with recirculation measured by a validated saline dilution technique using ultrasonic transducers placed on arterial and venous segments of the extracorporeal circulation (HDM, Transonic Systems, Inc.). Calculated access flows were compared by Bland Altman analysis. Data are given as mean +/- SD. RESULTS: A total of 104 measurements obtained in 52 treatments (17 patients, 18 accesses) were compared. Recirculation measured with correct placement of blood lines and corrected for the effect of cardiopulmonary recirculation using the 'double recirculation technique' was -0.02 +/- 0.14% by the BTM technique and not different from the 0% measured by the HDM technique. Recirculation measured with reversed placement of blood lines and corrected for the effect of cardiopulmonary recirculation was 19.66 +/- 10.77% measured by the BTM technique compared with 20.87 +/- 11.64% measured by the HDM technique. The difference between techniques was small (-1.21 +/- 2.44%) albeit significant. Access flow calculated from BTM recirculation was 1328 +/- 627 ml/min compared with 1390 +/- 657 ml/min calculated by the HDM technique. There was no bias between techniques. CONCLUSION: BTM thermodilution yields results which are consistent with the HDM ultrasound dilution technique with regard to both recirculation and access flow measurement.

Blood Circulation↗
PubMed1999

Effects of hemodialyzer reuse on clearances of urea and beta2-microglobulin. The Hemodialysis (HEMO) Study Group.

Although dialyzer reuse in chronic hemodialysis patients is commonly practiced in the United States, performance of reused dialyzers has not been extensively and critically evaluated. The present study analyzes data extracted from a multicenter clinical trial (the HEMO Study) and examines the effect of reuse on urea and beta2-microglobulin (beta2M) clearance by low-flux and high-flux dialyzers reprocessed with various germicides. The dialyzers evaluated contained either modified cellulosic or polysulfone membranes, whereas the germicides examined included peroxyacetic acid/acetic acid/hydrogen peroxide combination (Renalin), bleach in conjunction with formaldehyde, glutaraldehyde or Renalin, and heated citric acid. Clearance of beta2M decreased, remained unchanged, or increased substantially with reuse, depending on both the membrane material and the reprocessing technique. In contrast, urea clearance decreased only slightly (approximately 1 to 2% per 10 reuses), albeit statistically significantly with reuse, regardless of the porosity of the membrane and reprocessing method. Inasmuch as patient survival in the chronic hemodialysis population is influenced by clearances of small solutes and middle molecules, precise knowledge of the membrane material and reprocessing technique is important for the prescription of hemodialysis in centers practicing reuse.

Acetic Acid↗
PubMed1998

Time on dialysis.

This article discusses the following three aspects of dialysis that are related primarily in that they deal with time (ie, the duration of dialysis treatments): (1) Which is better: long or short daily dialysis? (2) Does everyone need long dialysis? (3) How does time affect the measurement of the dialysis dose? As a working definition, short implies the least time necessary to provide equilibrated Kt/V or double-pool Kt/V (eKt/V) of 1.0 and remove intradialytic weight gain without symptoms. This article makes the following statements regarding time on dialysis: (1) The duration of the dialysis treatment for daily dialysis has different effects on the removal of small and large molecules. (2) Longer treatments are definitely indicated for some patients with poor compensation for rapid ultrafiltration. (3) Short treatments with high rates of clearance/volume are associated with more postdialysis urea rebond. It is therefore an advantage to express doses as equilibrated Kt/V.

Humans↗
PubMed1998

Initial results of a new access device for hemodialysis technical note.

BACKGROUND: A new subcutaneous device (DIALOCKtrade mark) provides vascular access to patients who currently require hemodialysis (HD). The device consists of a port-like valve, implanted subcutaneously below the clavicle, which provides a linear flow passage to two catheters placed in the right atrium via the internal or external jugular vein. The valve is accessed percutaneously with needle-cannulas that functionally convert the device to twin catheters for connecting the patient to the HD lines. METHODS: The device was implanted in 10 outpatients under local anesthesia. Patients used the device during dialysis 3 times/week, and data were collected on blood flow, pressures, adverse events and patient and nurse satisfaction. RESULTS: The device was used for HD almost immediately (median 3 days after implantation) and functioned successfully for more than nine months (mean +/- SD 7.3 +/- 1.5) in all but one patient who died of unrelated causes after one month; there were >800 dialysis sessions total. Blood flows over 300 ml/min were consistently achieved (average 326 +/- 40) with venous and arterial pressures of 200 +/- 44 and -246 +/- 29 mm Hg, respectively. After 66 patient-months, condition of the needle puncture sites remained satisfactory. Five systemic infections occurred in four patients, producing 2.3 bacteremic episodes per 1000 patient-days. All resolved without the need for device removal. There were no infections at the puncture sites. Two patients required fibrin sheath stripping of their catheters, one whose heparin lock was not changed for 23 days (for reasons unrelated to the device). Patient and nurse acceptance was excellent. CONCLUSION: The device represents a positive improvement in the area of HD access.

Adult↗
PubMed1998

Association of serum phosphorus and calcium x phosphate product with mortality risk in chronic hemodialysis patients: a national study.

Elevated serum phosphorus is a predictable accompaniment of end-stage renal disease (ESRD) in the absence of dietary phosphate restriction or supplemental phosphate binders. The consequences of hyperphosphatemia include the development and progression of secondary hyperparathyroidism and a predisposition to metastatic calcification when the product of serum calcium and phosphorus (Ca x PO4) is elevated. Both of these conditions may contribute to the substantial morbidity and mortality seen in patients with ESRD. We have analyzed the distribution of serum phosphorus in two large national, random, cross-sectional samples of hemodialysis patients who have been receiving dialysis for at least 1 year. Data were obtained from two special studies of the United States Renal Data System, the Case Mix Adequacy Study (1990) and the Dialysis Morbidity and Mortality Study Wave 1 (1993). The relative risk of death by serum phosphorus quintiles is described after adjusting for age at onset of ESRD, race, sex, smoking status, and the presence of diabetes, the acquired immunodeficiency syndrome, and/or neoplasm. Logistic regression analysis is then used to describe the demographic, comorbid, and laboratory parameters associated with high serum phosphorus. Serum phosphorus was similar in these two study populations and averaged 6.2 mg/dL. Ten percent of patients had levels greater than 9 mg/dL and at least 30% of each group had serum phosphorus levels greater than 7 mg/dL. The adjusted relative risk of death by serum phosphorus level was not uniform across all quintiles, being constant below a level of 6.5 mg/dL and increasing significantly above this level. The relative risk of death for those with a serum phosphorus greater than 6.5 mg/dL was 1.27 relative to those with a serum phosphorus of 2.4 to 6.5 mg/dL. This increased risk was not diminished by statistical adjustment for coexisting medical conditions, delivered dose of dialysis, nutritional parameters, or markers of noncompliance. Evaluation of predictors of serum phosphorus greater than 6.5 mg/dL revealed in multivariate analysis that younger age at onset of ESRD, female sex, white race, diabetes, active smoking, and higher serum creatinine levels were all significant predictors. Analysis of serum calcium revealed no correlation with relative risk of death. The Ca x PO4 product, however, showed a mortality risk trend similar to that seen with serum phosphorus alone. Those in the highest quintile of the Ca x PO4 product (>72 mg2/dL2) had a relative mortality risk of 1.34 relative to those with products of 42 to 52 mg2/dL2. The relative mortality risk by log parathyroid hormone (PTH) level was elevated for patients with higher levels, but the mortality risk associated with hyperphosphatemia was independent of PTH. For hemodialysis patients who have been receiving dialysis for at least 1 year, we conclude that a large percentage have a serum phosphorus level above 6.5 mg/dL and that this places them at increased risk of death. This increased risk is independent of PTH. The mechanism(s) responsible for death is unknown, but may be related to an abnormally high Ca x PO4 product. Although mechanisms are not clearly established, this study supports the need for vigorous control of hyperphosphatemia to improve patient survival.

Adult↗
PubMed1998

Stability of access resistance during haemodialysis.

BACKGROUND: Access blood flow (Qac) is considered a useful indicator in the surveillance of haemodialysis access function. However, changes in Qac may be due to changes in blood pressure and/or to changes in access resistance (AR). METHODS: Weekly readings of Qac, cardiac output, and arterial blood pressure measured early and late during haemodialysis were obtained in 11 patients for a period of 3 weeks. Qac was determined from thermodilution of extracorporeal blood returning to the patient with reversed placement of blood lines and by measurement of arterial and venous blood temperatures in the extracorporeal circulation. Data are given as mean +/- SE. RESULTS: Qac dropped as mean arterial pressure (MAP) and total peripheral resistance (TPR) decreased, but increased when MAP and TPR increased. Linear regressions between the change in access flow and the change in MAP (deltaQac%=0.80*deltaMAP%-1.6, r2=0.39), and the change in TPR (deltaQac%= 0.54*deltaTPR%-9.2, r2=0.35) respectively, were significant (P<0.001). Whereas Qac significantly decreased (-8.4+/-3.3%, P<0.01) during the same treatment, AR remained unchanged (4.7+/-3.2%; P=NS). AR for all studies was 16.5+/-1.0 peripheral resistance units (1 PRU=2.226 kPa min l(-1)). There was a trend for resistance to increase (5.1+/-2.6%, P=NS) and for flow to decrease (-6.1+/-2.3%, P=NS) during the 3 weeks of the study. CONCLUSION: Qac measured during haemodialysis is variable and depends on haemodynamics, but AR is constant. AR is related to the physical structure of the peripheral access. Because of its intradialytic stability AR may be better suited as an indicator of access function.

Blood Pressure↗
PubMed1998

Dynamics of segmental extracellular volumes during changes in body position by bioimpedance analysis.

Extracellular volume (ECV) of arms, trunk, and legs determined from segmental bioimpedance data in 11 healthy men (31.6 +/- 7 yr) obtained at the end of a 30-min equilibration phase in the supine body position was compared with ECV determined from whole body measurements (ECVWB). ECV was calculated from extracellular resistance (RECV) identified from the bioimpedance spectrum for a range of 10 frequencies. Whole body RECV (527.6 +/- 55.6 Omega) was equal to the sum of RECV in the arms, trunk, and legs (241.6 +/- 36. 3, 49.2 +/- 5.1, and 236.3 +/- 25.5 Omega, respectively). The sum of equilibrated ECV in arms (1.31 +/- 0.25 liters), trunk (10.08 +/- 1.65 liters), and legs (2.80 +/- 0.82 liters) was smaller than ECVWB (20.90 +/- 2.59 liters). In six subjects who changed from a standing to a supine body position, ECV decreased in arms (-2.59 +/- 2.51%, P = NS) and legs (-10.96 +/- 3.02%, P < 0.05) but increased in the trunk (+4.2 +/- 3.2%, P < 0.05). ECVWB also decreased (-4.98 +/- 1. 41%, P < 0.05). However, the sum of segmental extracellular volumes remained unchanged (-0.06 +/- 0.07%, P = NS). The sum of segmental ECVs is not sensitive to changes in body position, which otherwise interferes with the estimation of ECV in bioimpedance analysis when ECVWB is used.

Adult↗
PubMed1998

Effects of controlled blood cooling on hemodynamic stability and urea kinetics during high-efficiency hemodialysis.

Although the use of cooled dialysate during hemodialysis is associated with stabilization of intradialytic BP, the effects of blood cooling on hemodynamics and urea kinetics in high-efficiency hemodialysis have not been completely studied. In particular, the effects of blood cooling have not been elucidated in very short-time, high K/V dialysis treatments, in which postdialysis urea rebound is maximized. In theory, blood cooling could increase urea compartmentalization during treatment and decrease dialysis efficacy. Measurements of cardiovascular hemodynamics and urea kinetics were performed in 15 patients (56 studies) during dialysis, using a blood temperature monitor with control of dialysate temperature. Dialysate temperature was adjusted to either lower the core temperature or raise the core temperature by, respectively, producing negative heat-energy exchange (cooled dialysis) or keeping heat-energy exchange in the extracorporeal circuit neutral (thermoneutral dialysis) so that energy was not transferred to or from the patient. Each subject was studied on both protocols, thereby allowing each individual to act as his own control. In cooled dialysis, heat-energy exchange in the extracorporeal circuit was -266+/-15 kJ per treatment, and dialysate temperature averaged 35.7+/-0.02 degrees C. In thermoneutral dialysis, heat-energy exchange in the extracorporeal circuit averaged 5+/-31 kJ per treatment, and dialysate temperature averaged 37.1+/-0.02 degrees C. Dialysate cooling resulted in a reduction in mean body temperature compared with thermoneutral therapy (-0.22+/-0.04 versus +0.31+/-0.05 degrees C). Cooling resulted in a greater increase in peripheral vascular resistance index (+515+/-160 versus + 114+/-92 dyn.sec/cm5 per m2), an increase in mean arterial pressure (+4+/-3 versus -4+/-4 mmHg), a reduction in the maximum intradialytic fall in mean arterial pressure (-10+/-2 versus -18+/-3, mmHg), and a reduction in staff interventions for hypotension or dialytic symptoms (6 of 28 versus 12 of 28 studies). These differences occurred without differences in the change in blood volume (-14.3+/-1.8% versus -13.9+/-2.2%) or cardiac index (-0.4+/-0.1 versus -0.4+/-0.2, L/min per m2). Urea rebound (37+/-4% versus 38+/-3%) and effective Kt/V (1.29+/-0.05 versus 1.32+/-0.06) were not different between groups. Thus, body temperature cooling can be used to stabilize BP and reduce intradialytic events requiring staff intervention without compromising the efficacy of treatment in high-efficiency dialysis.

Blood↗
PubMed1997

Clinical outcome relative to the dose of dialysis is not what you think: the fallacy of the mean.

Several recent retrospective studies of mortality relative to the dose of dialysis have been widely interpreted to indicate that adequate thrice-weekly hemodialysis requires a single pool Kt/V (spKt/V) of at least 1.4 to 1.6 and higher. In these studies, mortality rate has been correlated to the mean delivered spKt/V, (spKt/Vd)m, with coefficient of variation (CV) on the means ranging up to 45%. To evaluate these reported relationships, two large databases were analyzed using population constants to transform urea reduction ratio and spKt/Vd to equilibrated Kt/Vd (eKt/Vd), which expresses dose corrected for treatment time. The eKt/V dose (D) values were correlated to the reported relative risks (RR) of mortality to derive a RR/D function. The RR/D function, derived from these data with stepwise linear regression analysis, is nonlinear, with a steep linear increase in RR for eKt/Vd less than 1.05 and constant RR for eKt/Vd > or = 1.05. This RR/D function is mathematically expressed as RR = 1.96 - 1.03(eKt/Vd) (equation 1) when 0.50 < or = eKt/Vd < or = 1.05, and RR = 0.88 (equation 2) when eKt/V > or = 1.05. We show that regression of RR on (eKt/Vd)m with large CV results in overestimation of RR relative to eKt/Vd for individual patients because of extrapolation of the linear relationship beyond the threshold where the slope becomes zero (see equation 2 above). It is concluded that (1) current clinical data indicate that adequate dialysis is provided with eKt/Vd of 1.0 to 1.1 on a thrice-weekly schedule, (2) it is essential to assure that all patients achieve this level of therapy, which is best accomplished using urea kinetic modeling for both prescription and measurement of delivered eKt/Vd, and (3) the current HEMO study is well designed to determine whether higher levels of eKt/Vd will further improve clinical outcome.

Female↗
PubMed1997

Comparison of methods to predict equilibrated Kt/V in the HEMO Pilot Study.

The ongoing HEMO Study, a National Institutes of Health (NIH) sponsored multicenter trial to test the effects of dialysis dosage and membrane flux on morbidity and mortality, was preceded by a Pilot Study (called the MMHD Pilot Study) designed to test the reliability of methods for quantifying hemodialysis. Dialysis dose was defined by the fractional urea clearance per dialysis determined by the predialysis BUN and the equilibrated postdialysis BUN after urea rebound is completed (eKt/V). In the Pilot Study the blood side standard for eKt/V was calculated from the predialysis, postdialysis, and 30-minute postdialysis BUN. Four techniques of approximating eKt/V that eliminated the requirement for the 30-minute postdialysis sample were also evaluated. The first adjusted the single compartment Kt/V using a linear equation with slope based on the relative rate of solute removal (K/V) to predict eKt/V (rate method). The second and third techniques used equations or mathematical curve fitting algorithms to fit data that included one or more samples drawn during dialysis (intradialysis methods). The fourth technique (dialysate-side) predicted eKt/V from an analysis of the time-dependent profile of dialysate urea nitrogen concentrations (BioStat method; Baxter Healthcare, Inc., Round Lake, IL, USA). The Pilot Study demonstrated the feasibility of conventional and high dose targets of about 1.0 and 1.4 for eKt/V. Based on the blood side standard method, the mean +/- SD eKt/V for patients randomized to these targets was 1.14 +/- 0.11 and 1.52 +/- 0.15 (N = 19 and 16 patients, respectively). Single-pool Kt/Vs were about 0.2 Kt/V units higher. Results were similar when eKt/V was based on dialysate side measurements: 1.10 +/- 0.11 and 1.50 +/- 0.11. The approximations of eKt/V by the three blood side methods that eliminated the delayed 30-minute post-dialysis sample correlated well with eKt/V from the standard blood side method: r = 0.78 and 0.76 for the single-sample (Smye) and multiple-sample intradialysis methods (N = 295 and 229 sessions, respectively) and 0.85 for the rate method (N = 295). The median absolute difference between eKt/V computed using the standard blood side method and eKt/V from the four other methods ranged from 0.064 to 0.097, with the smallest difference (and hence best accuracy) for the rate method. The results suggest that, in a dialysis patient population selected for ability to achieve an equilibrated Kt/V of about 1.45 in less than a 4.5 hour period, use of the pre and postdialysis samples and a kinetically derived rate equation gives reasonably good prediction of equilibrated Kt/V. Addition of one or more intradialytic samples does not appear to increase accuracy of predicting the equilibrated Kt/V in the majority of patients. A method based on dialysate urea analysis and curve-fitting yields results for equilibrated Kt/V that are similar to those obtained using exclusively blood-based techniques of kinetic modeling.

Blood Urea Nitrogen↗
PubMed1997

The National Kidney Foundation Dialysis Outcomes Quality Initiative.

Rigorously developed clinical practice guidelines have the potential to change practice patterns to obtain improved patient outcomes. Toward that end, in March 1995 the National Kidney Foundation initiated the Dialysis Outcomes Quality Initiative, a comprehensive effort to create literature-based clinical practice guidelines in nephrology. Independent interdisciplinary work groups reviewed the available body of scientific literature on the following topics: hemodialysis adequacy, peritoneal dialysis adequacy, vascular access, and anemia. More than 11,000 papers were identified; of these approximately 1500 were found to be relevant, requiring formal structured review. Work groups formulated draft guidelines with supporting rationales that included the evidentiary basis for the recommendations. The draft guidelines were subjected to an unprecedented three-stage review process that involved more than 50 organizations from the renal community, including end-stage renal disease networks, patients dialysis providers, managed care organizations, and government. The finalized guidelines were issued in September 1997. Planned guideline implementation activities will focus on achieving the following: cooperation from the renal community; education of patients, clinicians, policy makers, and dialysis providers; information system tools to facilitate adoption of the guidelines; and evaluation strategies to determine whether practice patterns and outcome goals are achieved.

Humans↗
PubMed1996

High flux dialysis membranes improve plasma lipoprotein profiles in patients with end-stage renal disease.

A major cause of the morbidity and mortality of patients with end-stage renal disease (ESRD) is related to disorders of large blood vessels, especially coronary heart disease. Atherosclerosis, the most common form of this disease, is known to result from abnormalities in plasma lipoproteins, as well as from factors that damage the vessel wall. Two well-known risk factors for coronary heart disease are elevated plasma concentrations of LDL and reduced concentrations of HDL. This latter disorder is often accompanied by elevated triglycerides. Low HDL and elevated triglycerides are commonly associated with ESRD. Dialysis with high flux membranes differs from conventional dialysis in a number of ways. These include better biocompatibility and increased flux of larger molecules. Although several previous studies had suggested that dialysis with high flux membranes improves plasma lipoprotein profiles, a definitive cross-over designed study to assess the roles of high flux versus biocompatibility in altering lipoprotein profiles had not been done. Preliminary data from such a study are presented. These data confirm the beneficial effects of high flux membranes to reduce plasma triglycerides and suggest that this effect is primarily due to the high flux, and not the biocompatible, feature of the membranes.

Humans↗
PubMed1995

Solute disequilibrium and multicompartment modeling.

Mathematical models that simulate the exchange of solute between multiple body compartments have been used to study the distribution, elimination, and transport of urea, water, electrolytes, and other substances in the dialysis patient. Within a compartment, such substances are assumed to be uniformly distributed while exchange between compartments or with the environment may occur in a number of different ways. Diffusion in response to concentration gradients between, for example, intracellular and extracellular spaces, and convection due to blood flow have been identified as the most important transport mechanisms. Any system with more than one compartment may develop nonuniform solute distribution or solute disequilibrium between compartments. The minimum number of compartments required to model a kinetic process such as urea removal during hemodialysis depends on the accuracy and temporal resolution required, with higher resolution calling for more compartments. A two-compartment model is adequate for most clinical purposes. The physiological meaning or anatomic counterparts of the mathematical compartments remain uncertain as both flow and diffusion transport mechanisms contribute to the disequilibrium. Processes such as access and cardiopulmonary recirculation may be represented as additional compartments with small distribution volumes and high mass transport rates. Failure to recognize the effect of multiple compartments will result in an inaccurate measurement of dialysis dose and an inadequate hemodialysis prescription with a predictably poor clinical outcome. Allowance for compartment effects is particularly important in patients receiving treatment with a high ratio of dialyzer clearance to total body water, now commonly encountered during short-time, high-efficiency dialysis.

Biological Transport↗