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Adam M. Zawada
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Beatrix Zheng
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Zawada, A.M.;  Lang, T.;  Ottillinger, B.;  Kircelli, F.;  Stauss-Grabo, M.;  Kennedy, J.P. Hydrophilic Modification of Dialysis Membranes. Encyclopedia. Available online: https://encyclopedia.pub/entry/32949 (accessed on 27 July 2024).
Zawada AM,  Lang T,  Ottillinger B,  Kircelli F,  Stauss-Grabo M,  Kennedy JP. Hydrophilic Modification of Dialysis Membranes. Encyclopedia. Available at: https://encyclopedia.pub/entry/32949. Accessed July 27, 2024.
Zawada, Adam M., Thomas Lang, Bertram Ottillinger, Fatih Kircelli, Manuela Stauss-Grabo, James P. Kennedy. "Hydrophilic Modification of Dialysis Membranes" Encyclopedia, https://encyclopedia.pub/entry/32949 (accessed July 27, 2024).
Zawada, A.M.,  Lang, T.,  Ottillinger, B.,  Kircelli, F.,  Stauss-Grabo, M., & Kennedy, J.P. (2022, November 04). Hydrophilic Modification of Dialysis Membranes. In Encyclopedia. https://encyclopedia.pub/entry/32949
Zawada, Adam M., et al. "Hydrophilic Modification of Dialysis Membranes." Encyclopedia. Web. 04 November, 2022.
Hydrophilic Modification of Dialysis Membranes
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This entry is adapted from the peer-reviewed paper 10.3390/membranes12100932

The dialyzer is the core element in the hemodialysis treatment of patients with end-stage kidney disease (ESKD). During hemodialysis treatment, the dialyzer replaces the function of the kidney by removing small and middle-molecular weight uremic toxins, while retaining essential proteins. Meanwhile, a dialyzer should have the best possible hemocompatibility profile as the perpetuated contact of blood with artificial surfaces triggers complement activation, coagulation and immune cell activation, and even low-level activation repeated chronically over years may lead to undesired effects. During hemodialysis, the adsorption of plasma proteins to the dialyzer membrane leads to a formation of a secondary membrane, which can compromise both the uremic toxin removal and hemocompatibility of the dialyzer. Hydrophilic modifications of novel dialysis membranes have been shown to reduce protein adsorption, leading to better hemocompatibility profile and performance stability during dialysis treatments.

dialysis performance hemocompatibility membrane protein fouling

1. Introduction

The global prevalence of end-stage kidney disease (ESKD) is rising steadily, mainly caused by the increasing prevalence of ESKD risk factors such as hypertension and diabetes mellitus, higher life expectancy of the general population and better survival of ESKD patients due to improved treatment options [1][2]. While kidney transplantation is the preferred treatment option for eligible ESKD patients, most patients depend on a renal replacement therapy [2]. This therapy can be performed at home with peritoneal dialysis or by extracorporeal treatments, such as low- and high-flux hemodialysis (HD), including low dialysate flow daily HD [3], or hemodiafiltration (HDF), which are the predominant treatment options for patients with ESKD [2][4][5]. In these extracorporeal treatments, a dialyzer replaces the function of the malfunctioning kidney, that is, elimination of a wide range of uremic toxins, e.g., ß2-microglobulin, urea, uric acid, or creatinine, and of excess fluid, while preventing loss of essential proteins, such as albumin [6][7]. This function of a dialyzer is called the performance and is generally described by clearance and sieving coefficient values in the instructions for use of the manufacturers. Performance factors are primarily influenced by the dialyzer membrane, including its composition, membrane morphology and structure (e.g., mean pore size, pore size distribution, surface area, membrane thickness) and adsorptive properties [8][9][10][11][12][13]. Besides strong performance, hemocompatibility is another core element of a dialyzer. Contact of human blood to artificial surfaces of the dialyzer may activate the immune system, leading to complement activation, coagulation and inflammation, with negative clinical consequences for the patients [14][15][16][17]. Additionally, here, the membrane has the strongest effect on the hemocompatibility profile of the dialyzer, as it has the largest contact surface with the patients’ blood during dialysis.

During hemodialysis treatment, the adsorption of plasma proteins to the blood-side surface of the dialyzer membrane can strongly impact both performance as well as the hemocompatibility profile of the dialyzer. Importantly, hydrophilic membrane modifications reduce protein adsorption and improve the performance and hemocompatibility profile of a dialyzer.

2. Reduction in Membrane Fouling by Hydrophilic Modifications

Over the course of the last several decades, dialyzer membrane research has focused on improving both performance and hemocompatibility. As protein adsorption to the membrane impacts both–performance and hemocompatibility–membrane modifications with the aim to reduce secondary membrane formation during dialysis treatment were in the focus of latest dialyzer development. For synthetic membranes, such as polysulfone or polyethersulfone-based membranes, polyvinylpyrrolidone (PVP) is commonly used as a hydrophilic agent. PVP has good physiological inertness and reduces protein adsorption via repulsive hydration force of the formed water layer [18][19][20][21][22][23]. Wang et al. fabricated polyethersulfone-based membranes with increased PVP content and found that those membranes with higher PVP content showed stronger water adsorption and were associated with reduced albumin adsorption as well as increased blood coagulation time [74]. In line, Zhu and colleagues prepared and characterized polysulfone membranes with different amounts of PVP and found that membranes with higher PVP content showed lower protein adsorption, reduced platelet adhesion and deformation as well as improved blood clotting characteristics  [19]. Differences in PVP content in polysulfone-based membranes also affect the roughness of the membrane in dry or wet condition and are strong determinants for the swelling of the membrane after contact with water [18][22]. These findings are schematically summarized in Figure 1.

/media/item_content/202211/636875b18679bmembranes-12-00932-g002.png
Figure 1. Schematic illustration of complement activation, coagulation and immune cell activation by a membrane with strong protein adsorption as compared to a hydrophilic membrane with lower protein adsorption. Increase in hydrophilicity can be achieved by an increased content of the hydrophilic agent polyvinylpyrrolidone (PVP) on the blood-side surface of the membrane, which reduces protein adsorption via repulsive hydration force of the formed water layer. Protein binding to the membrane leads to conformational changes or denaturation of protein structures which can subsequently trigger complement activation, coagulation, and immune cell activation.

3. Maintaining Hydrophilic Modification of Dialysis Membranes

While the increase in PVP content on the blood-side surface of the membrane leads to increased hydrophilicity and subsequently to lower protein fouling and better hemocompatibility as well as performance stability, the PVP must remain on the blood-side membrane surface in order to have an effect. Unfortunately, it has been well established that PVP can be eluted from the membrane during dialysis treatment [24][25]. This section discusses both the potentially undesirable effects of eluted PVP, as well as the predominant factors that lead to the phenomenon.

3.1. Undesirable Effects of Elutable PVP

The reduction in PVP content caused by PVP elution comes not only with negative implications for the hemocompatibility profile and performance of the membrane, but PVP may itself have direct negative impacts on the patient.
It has long been understood that PVP can be taken up by, e.g., macrophages and lead to storage disease by accumulation of PVP in different tissues or organs such as liver, kidneys or lymph nodes. This disorder has been seen in patients who received PVP injections as plasma substitute in former times [26][27], but up to now no data is available which shows that the elution of PVP from dialyzers may lead to a significant accumulation in the patients’ body.
More recently some reports speculated that eluted PVP could be a cause for adverse reactions, such as hypersensitivity reactions or thrombocytopenia, which rarely occur during treatment with synthetic membranes [12][28][29][30][31][32]. Konishi et al. [33] investigated this potential impact of PVP elution on patient reactions by recruiting patients who previously experienced adverse reactions during treatment with synthetic membranes (defined as hypotension, malaise or symptoms of anaphylactic shock). By performing a skin prick test with PVP, the authors found that none of the 7 patients reacted positive on this test. Therefore, the authors concluded that not PVP, but other factors should be causative for these infrequently occurring adverse patient reactions during treatment with synthetic membranes. Despite the suspicion surrounding PVP, there is currently no clinical study which showed a causal relationship between PVP elution and adverse patient reactions. Nevertheless, there is good reason to avoid elution of PVP from the membrane even if it is only to avoid the negative implications for the performance and hemocompatibility profile of the dialyzer.

3.2. Factors Influencing PVP Elution

The polymer backbone of PVP can undergo free-radical oxidation. Blood-side oriented chains of PVP that are especially important for binding water and generating the protein-repulsive layer of PVP-bound water (hydrolayer) are susceptible to polymer chain breaks that leave these chains no longer anchored to the membrane. These unanchored PVP fragments can be eluted from the membrane during dialysis treatment, leaving gaps in the protective hydrolayer of the membrane. Generation of elutable PVP fragments can occur either relatively quickly during high-energy sterilization processes, or more slowly over long periods of time. Additionally, shear stress within the capillary membrane has been shown to influence PVP elution. These factors are considered in more detail below.
The type of dialyzer sterilization is a strong determinant for PVP elution. For example, gamma sterilization has been discussed to stabilize PVP in the membrane, by crosslinking PVP with the membrane and was shown to induce lower PVP elution than autoclave sterilization [25][34][35]. The researchers recently also investigated PVP elution across six synthetic dialyzers sterilized with gamma, autoclave steam or INLINE steam [34]. In agreement with previous reports, the researchers observed that autoclave steam sterilization was associated with approx. 3.5-fold higher PVP elution than gamma sterilization. Moreover, lowest PVP elution was found for the INLINE steam sterilized dialyzers (p < 0.001 vs. gamma and autoclave steam sterilized dialyzers), where all measurements were below the quantification limit of the method. The low PVP elution from membranes that were sterilized with INLINE steam may be explained by the fact that during the sterilization process the membranes are continuously rinsed with steam and sterile water, that allow efficient removal of any PVP generated during the manufacturing process [36].
Storage time over the shelf life of dialyzers is another determinant for PVP elution from the membranes. Miyata et al. [35] investigated the impact of storage time on PVP elution from autoclave steam and gamma sterilized dialyzers. The authors found a strong correlation between the amount of PVP eluted by washing and the storage period for both dialyzers (r = 0.958, p < 0.001 and r = 0.952, p < 0.001). Here, oxidation of PVP over time is a factor which leads to the increased PVP elution during storage [35][37]. Therefore, novel membranes have been developed which shall prevent this oxidation and stabilize PVP in the membrane [34][38][39][40][41]. This stabilization was achieved by adding small amounts of the anti-oxidant α-tocopherol to the membrane. In contrast to bioactive membranes, which also use α-tocopherol to achieve therapeutic effects [42][43], the concentration in these novel membranes is much lower, as it just has the aim to stabilize PVP in the membrane. In combination with INLINE steam sterilization, such membranes show no detectable PVP elution [34]. This is also the case when investigating the complete shelf-life of three years of the dialyzers. Figure 2 summarizes these findings on PVP elution and the effects of storage time and different sterilization methods.
/media/item_content/202211/636875dd6aa4amembranes-12-00932-g004.png
Figure 2. Impact of sterilization method and storage time on PVP elution from dialyzers. Comparison of the amount of eluted PVP in a recirculation system with water for 4 h, as described before [34]. Displayed is the blood-side PVP elution from the INLINE steam sterilized dialyzer FX CorAL 600 (Fresenius Medical Care; n = 9) over shelf life as compared to gamma (xevonta Hi 15, B. Braun and ELISIO 17H, Nipro; n = 3 each) and autoclave steam (Polyflux 170H, Baxter and Theranova 400, Baxter; n = 3 each) sterilized dialyzers, reanalyzed from recently published data [34]. The PVP detection limit for the respective method is 0.5 mg/L; in case of results below detection limit, data are presented as half of the detection limit, as described before [34]. N/A: For these gamma and autoclave steam sterilized dialyzers, no data over shelf life was available; measurement was performed at one time point within their specified shelf life.
Finally, elution of PVP can also be exacerbated through shear stress and filtration, which was investigated by Matsuda et al. [24] in an experimental approach by using a dextran solution as blood substitute. In shear-stress loading experiments up to 144 h, the authors found a correlation between lower PVP retention in the membrane with higher shear-stress loading time and higher magnitude of shear stress. Such results were confirmed by Namekawa et al. [25] showing that increasing shear stress directly increases the elution of PVP. Moreover, the authors investigated the hardness and adsorption force of human serum albumin on membrane surfaces with atomic force microscopy. Here, they found that with increasing shear stress the hardness and the adsorption force of albumin increased, indicating that shear stress induced PVP elution may lead to increased protein adsorption on the membrane during dialysis treatment, which may then have negative implications on the hemocompatibility profile and performance characteristics of the membrane.
Low PVP elution should be an aim of dialyzer membranes both to maintain the benefits of increased hydrophilicity on the performance and hemocompatibility profile of dialyzer membranes during treatment, and to avoid the potentially deleterious effects of eluted PVP.

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Subjects: Materials Science, Biomaterials
Contributors MDPI registered users' name will be linked to their SciProfiles pages. To register with us, please refer to https://encyclopedia.pub/register :
Adam M. Zawada
,
Thomas Lang
,
Bertram Ottillinger
,
Fatih Kircelli
,
Manuela Stauss-Grabo
,
James P. Kennedy
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Update Date: 07 Nov 2022
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