Hemodialysis.com Research Interviews

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Hemodialysis.com

Hemodialysis research, author interviews, dialysis updates and information on chronic kidney disease and end stage renal failure.

Editor: Marie Benz, [email protected]

December 15 2012

For Informational Purposes Only: Not for Specific Medical Advice.

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Hemodialysis.com InterviewsDecember 6-16 2012


Local Complement-Targeted Intervention in Periodontitis: Proof-of-Concept Using a C5a Receptor (CD88) AntagonistHemodialysis.com Author Interview:

George Hajishengallis, D.D.S., Ph.D.Professor, Dept. of Microbiology University of Pennsylvania School of Dental Medicine

• Hemodialysis.com Editor Marie Benz: What are the main findings of the study?

• Our study showed that the complement system synergizes with Toll-like receptors to induce destructive inflammation in the periodontal tissue. Specifically, maximal inflammation in preclinical models of periodontitis required a crosstalk between the complement C5a receptor (C5aR) and Toll-like receptor 2 (TLR2).

• Importantly, pharmacological blockade of just one of the receptors involved (C5aR) inhibited inflammation and the destruction of bone that supports the teeth. This treatment was applied locally in the gingiva and was effective regardless of whether the C5aR antagonist was administered in a preventive or a therapeutic mode.

• Hemodialysis.com: Were any of the findings unexpected?

• Since destructive inflammation and bone loss required both C5aR and TLR2, one might have expected that both receptors had to be blocked to prevent or halt the disease. However, significant inhibition of disease activity was seen by just blocking C5aR alone, indicating a true synergy between C5aR and TLR2.

• What was completely unexpected was discovered in our previous work; C5aR does not only mediate destructive inflammation but is also hijacked by certain periodontal bacteria to escape immune clearance.

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Local Complement-Targeted Intervention in Periodontitis: Proof-of-Concept Using a C5a Receptor (CD88) AntagonistHemodialysis.com Author Interview:

George Hajishengallis, D.D.S., Ph.D. Professor, Dept. of Microbiology University of Pennsylvania School of Dental Medicine

(cont)

• Hemodialysis.com: What should clinicians and patients take away from your report?

• Periodontitis affects more than 47% of the U.S. adult population, and in its most severe form, which affects 8.5% of adults, can affect systemic health.

Our findings suggest that complement therapeutics may offer treatment solutions for periodontitis patients and thereby reduce their risk for associated systemic diseases.

• Hemodialysis.com: What recommendations do you have for future research as a result of this study?

• A better understanding of the role of the various complement pathways in periodontitis may identify additional targets for even better treatment solutions. For instance, blocking complement activity upstream of C5aR may be more beneficial if additional pathways contribute to the disease.

We are currently testing these ideas in various periodontal disease animal models and hopefully we can initiate human clinical trials in the near future.

• Reference:• Local Complement-Targeted Intervention in Periodontitis: Proof-of-Concept Using a C5a Receptor (CD88) Antagonist

Toshiharu Abe, Kavita B. Hosur, Evlambia Hajishengallis, Edimara S. Reis, Daniel Ricklin, John D. Lambris, and George HajishengallisJ Immunol 2012 189:5442-5448; published ahead of print October 22, 2012, doi:10.4049/jimmunol.1202339



http://www.hemodialysis.com/author_interviews/local_complement_targeted_intervention_in_periodontitis.html

Plasma metabolomic profiles in different stages of CKDHemodialysis.com Author Interview: Vallabh O. Shah, PhD,* David L. Vander Jagt, PhD,* Raymond R. Townsend, MD, + Harold I. Feldman, MD+

*University of New Mexico Health Sciences Center, Albuquerque NM; University of Pennsylvania, Perelman School of Medicine, Philadelphia PA


• GC/LC mass spectrometry was used to assess metabolites in plasma samples from non-diabetic men, with 10 participants each in CKD stages 2, 3, and 4.

Major differences in metabolite profiles with increasing stage of CKD were observed, which pointed to altered arginine metabolism and elevated coagulation/inflammation.

This was based upon the observation of marked increases in dimethylarginine and fibrinopeptide-A in progression from CKD-stage 2 to CKD-stage 3. This global metabolite profiling not only identified potential stage-specific biomarkers but also provided a potential, testable hypothesis regarding progression of CKD.


• It was unexpected that such a small sample size would give a clear delineation of the key metabolites. Generally a much larger sample size is required.


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Plasma metabolomic profiles in different stages of CKDHemodialysis.com Author Interview: Vallabh O. Shah, PhD,* David L. Vander Jagt, PhD,* Raymond R. Townsend, MD, + Harold I. Feldman, MD+

*University of New Mexico Health Sciences Center, Albuquerque NM; +University of Pennsylvania, Perelman School of Medicine, Philadelphia PA (cont)

• Hemodialysis.com: What should clinicians and patients take away from your report? • This study suggests that there are distinct changes in well-defined domains that may

help us to understand the graded increase in CVD risk as kidney function worsens, particularly regarding involvement of inflammation and coagulation.


• This initial study involved only non-diabetic men with CKD and was a cross-sectional study. Future longitudinal studies should evaluate both non-diabetic and diabetic populations, should determine differences related to gender and ethnicity, and should compare all stages of CKD up to ESRD and include transplant populations.

• Reference:• Plasma metabolomic profiles in different stages of CKD

Vallabh O. Shah, PhD,* David L. Vander Jagt, PhD,* Raymond R. Townsend, MD, + Harold I. Feldman, MD+ *University of New Mexico Health Sciences Center, Albuquerque NM; +University of Pennsylvania, Perelman School of Medicine, Philadelphia PA

















Cystatin C in children on chronic hemodialysis.Hemodialysis.com Author Interview: Olivera Marsenic Couloures M.D. Pediatric Nephrology, Oklahoma University Health Sciences Center, 1200 N. Phillips Ave., Suite 14200, Oklahoma City, OK, 73104, USA

• Hemodialysis.com Editor Marie Benz: What are the main findings of the study?• Our study showed that Cystatin C (CyC), and likely other middle molecules are not

removed with standard low-flux HD that is routine practice in children.

This increases the risk of poor outcomes. We also showed that CyC does not rise between HD and is not removed by very low residual renal function (RRF), and remains at steady-state. This suggests that its elimination in end-stage renal disease is extrarenal.

• We also found that in absence of its removal, CyC levels increase with patient age and size.


• Absence of removal of CyC with high HD doses achieved in children and a discrepancy in CyC levels seen in smaller and larger anuric children.

http://www.hemodialysis.com/author_interviews/cystatin_c_in_children_on_chronic_hemodialysis.html













Cystatin C in children on chronic hemodialysis.Hemodialysis.com Author Interview: Olivera Marsenic Couloures M.D. Pediatric Nephrology, Oklahoma University Health Sciences Center, 1200 N. Phillips Ave., Suite 14200, Oklahoma City, OK, 73104, USA

(Cont.)

• Hemodialysis.com: What should clinicians and patients take away from your report? • High-flux and other more intensified HD modalities should become routine in children in order to remove

larger molecules.

CyC should further be investigated as a marker of adequacy of these intensified HD regimens.

If using CyC for estimation of RRF, physicians should keep in mind that very low RRF does not affect CyC elimination and that in end stage disease serum CyC levels are dependant on patient age and size.

• Hemodialysis.com: What recommendations do you have for future research as a result of this study? • Our findings require confirmation on larger number of children of various ages, with both anuria and a

wider range of RRF.

• Reference:• Cystatin C in children on chronic hemodialysis.• Marsenic O, Wierenga A, Wilson DR, Anderson M, Shrivastava T, Simon GA, Beck AM, Swanson TJ,

Studnicka K, Elberg D, Couloures K, Turman MA.Pediatric Nephrology, Oklahoma University Health Sciences Center, 1200 N. Phillips Ave., Suite 14200, Oklahoma City, OK, 73104, USAPediatr Nephrol. 2012 Nov 21. [Epub ahead of print]







Elevated Serum Bone Morphogenetic Protein 4 in Patients with Chronic Kidney Disease and Coronary Artery Disease.Hemodialysis.com Author Interview: T. Cooper Woods, Ph.D.Head, Laboratory of Molecular Cardiology

Institute for Translational ResearchOchsner Clinic Foundation


• Chronic Kidney Disease is associated with increased vascular calcification. We found that serum levels of an osteogenic growth factor, Bone Morphogenetic Protein-4, were elevated in subjects with both chronic kidney disease and coronary artery disease. Furthermore, increases in serum BMP-4 levels correlated with increased coronary artery calcification.

• Hemodialysis.com: Were any of the findings unexpected? • Overall, I don’t think the findings were unexpected, however given the

small sample size, we were surprised at the strength of some of the associations.


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Elevated Serum Bone Morphogenetic Protein 4 in Patients with Chronic Kidney Disease and Coronary Artery Disease.Hemodialysis.com Author Interview: T. Cooper Woods, Ph.D.Head, Laboratory of Molecular Cardiology Institute

for Translational ResearchOchsner Clinic Foundation (cont)


• This is a small observational study that serves as a first step in examining the relationship between coronary artery disease, chronic kidney disease, and serum BMP-4. The study alerts clinicians and patients to the potential of osteogenic factors as future targets for the diagnosis and treatment of coronary artery disease in the kidney disease population.


• Larger prospective studies examining the relationship between serum concentrations of osteogenic factors and the extent of coronary artery disease in subjects with chronic kidney disease may lead to therapeutic or diagnostic tools for treating this high risk population.

• Reference: • Elevated Serum Bone Morphogenetic Protein 4 in Patients with Chronic Kidney Disease and Coronary

Artery Disease.Stahls PF 3rd, Lightell DJ Jr, Moss SC, Goldman CK, Woods TC.Department of Cardiology, Ochsner Clinic Foundation, New Orleans, LA, USA.J Cardiovasc Transl Res. 2012 Dec 4. [Epub ahead of print]














Preoperative Statin Use and Postoperative Acute Kidney InjuryHemodialysis.com Author Interview: Steven M. Brunelli, MD, MSCEHarvard Medical School, Boston, Massachusetts

Renal Division, Department of Medicine, Brigham and Women’s Hospital, Boston, MassachusettsChanning Laboratory, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts


• The primary finding of the study is that ongoing statin use was independently associated with 20-26% relative reduction in the risk of developing post-operative acute kidney injury.


• We were surprised that the benefit of statins was less among patients undergoing cardiac surgery versus other types of surgery.

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Preoperative Statin Use and Postoperative Acute Kidney InjurySteven M. Brunelli, MD, MSCEHarvard Medical School, Boston, Massachusetts

Renal Division, Department of Medicine, Brigham and Women’s Hospital, Boston, MassachusettsChanning Laboratory, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts(cont)

• Hemodialysis.com: What should clinicians and patients take away from your report? • Clinicians should be aware that these data, in association with other data suggesting

ameliorative effects on other post operative complications, support the continuation of statins in the peri-operative period.


• Future studies are needed to evaluate whether it is safe, efficacious, and efficient to initiate statins prior to surgery among patients at high risk for post-operative acute kidney injury.

• Reference:• Preoperative Statin Use and Postoperative Acute Kidney Injury

Steven M. Brunelli, Sushrut S. Waikar, Brian T. Bateman, Tara I. Chang, Joyce Lii, Amit X. Garg, Wolfgang C. Winkelmayer, Niteesh K. ChoudhryThe American Journal of Medicine - December 2012 (Vol. 125, Issue 12, Pages 1195-1204.e3, DOI: 10.1016/j.amjmed.2012.06.021)














Microalbuminuria and hyperfiltration in subjects with nephro-urological disordersHemodialysis.com Author Interview: Francois Cachat MDDepartment of Pediatrics, Division of Pediatric Nephrology, University Hospital, Lausanne, Switzerland

• Hemodialysis.com Editor Marie Benz: What are the main findings of the study?• In children with chronic nephro-urological disorders, there was only a weak

association between microalbuminuria and filtration fraction, and this only in children with a single kidney and normal GFR.

In all other patients, there was no assocation between microalbuminuria and filtration fraction.

• Hemodialysis.com: Were any of the findings unexpected? • The fact that children with a single kidney showed only a weak association

between microalbuminuria and filtration fraction is surprizing.

These children have lost 50% of their nephron mass, sometimes more, and one would expect a much stronger association in that case. Their young age might explain in part this negative finding.

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Microalbuminuria and hyperfiltration in subjects with nephro-urological disordersHemodialysis.com Author Interview: Francois Cachat MDDepartment of Pediatrics, Division of Pediatric Nephrology, University Hospital, Lausanne, Switzerland(cont)

• Hemodialysis.com: What should clinicians and patients take away from your report? • Microalbuminuria should not be used to suspect or detect hyperfiltration in children with

chronic nephro-urological disorders.


• It would be interesting to study subjects with a single kidney at a much later age, to see if they finally develop microalbuminuria in relation to a high filtration rate. Also, adult kidney donors would be interesting to study: adults might react differently to an acute loss of nephron than children with congenital anomalies.

• Reference:• Microalbuminuria and hyperfiltration in subjects with nephro-urological disorders

Francois Cachat, Christophe Combescure, Hassib Chehade, Gregory Zeier, Dolores Mosig, Blaise Meyrat, Peter Frey, and Eric GirardinMicroalbuminuria and hyperfiltration in subjects with nephro-urological disorders Nephrol. Dial. Transplant. first published online December 6, 2012 doi:10.1093/ndt/gfs494






Serum Adiponectin Levels and Mortality after Kidney Transplantation Hemodialysis.com Author Interview:

Ahsan Alam, MD, CM, MS, FRCP(C)Assistant Professor of Medicine Division of NephrologyMcGill University Health Centre - Royal Victoria Hospital

Montreal, Quebec, Canada H3A 1A1

• Hemodialysis.com Editor Marie Benz: What are the main findings of the study?• Our study examined the association of an adipose-tissue derived hormone, adiponectin, on clinical

outcomes in prevalent kidney transplant recipients.

We found plasma levels of adiponectin to be associated with a 44% increase hazard for all-cause mortality in a large cohort of prevalent, stable kidney transplant recipients.

This association was independent of estimated GFR and many conventional cardiovascular risk factors.

• Hemodialysis.com: Were any of the findings unexpected? • Adiponectin has been identified to have anti-inflammatory and cardioprotective properties in healthy

individuals, although patients with CKD and on hemodialysis exhibit a paradoxical risk relationship where higher levels are associated with adverse outcomes.

In stable kidney transplant recipients with partial restoration of kidney function we found this this protective role was not re-established. Instead, all-cause mortality was higher in those with higher plasma adiponectin levels.

Interestingly, death-censored graft failure was not associated with adiponectin.

Also, in our study we did not find the risk of adiponectin on all-cause mortality was accounted for by markers of malnutrition or inflammation.


Serum Adiponectin Levels and Mortality after Kidney Transplantation Hemodialysis.com Author Interview:

Ahsan Alam, MD, CM, MS, FRCP(C)Assistant Professor of Medicine Division of NephrologyMcGill University Health Centre - Royal Victoria Hospital

Montreal, Quebec, Canada H3A 1A1 (cont)

• Hemodialysis.com: What should clinicians and patients take away from your report? • Over the past several decades, advances in immunosuppression management have led to improved early graft and patient outcomes.

Nevertheless, the burden of cardiovascular mortality remains a central long-term challenge in this population. Attention should be placed on non-traditional cardiovascular risk factors.

Adiponectin, a non-traditional atherosclerotic risk factor in those with kidney disease, may help to identify individuals at a higher risk of all-cause mortality after kidney transplantation.

• Hemodialysis.com: What recommendations do you have for future research as a result of this study? • It remains unclear from our study whether plasma adiponectin levels are indeed pathologic or simply a biomarker for increased mortality after

kidney transplantation.

Factors that modulate plasma adiponectin levels and its relationship with other novel biomarkers should be explored.

Whether modifying adiponectin levels could represent a therapeutic target or directly alter patient outcomes remains to be determined in future clinical studies and trials.

• Reference:• Serum Adiponectin Levels and Mortality after Kidney Transplantation.

Alam A, Molnar MZ, Czira ME, Rudas A, Ujszaszi A, Kalantar-Zadeh K, Rosivall L, Mucsi I.Division of Nephrology, McGill University Health Centre, Montreal, Quebec, Canada;, †Institute of Pathophysiology and, ‡Institute of Behavioral Sciences, Semmelweis University, Budapest, Hungary;, §Harold Simmons Center for Chronic Disease Research & Epidemiology, University of California Irvine Medical Center, Irvine, California; Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California;, ‖Department of Medicine, Division of Nephrology, University Health Network, University of Toronto, Toronto, Ontario, Canada, ¶Division of Nephrology & Hypertension, University of California Irvine Medical Center, Orange, California.

Clin J Am Soc Nephrol. 2012 Dec 6. [Epub ahead of print]


Cost effectiveness of the interferon-γ release assay for tuberculosisscreening of hemodialysis patientsHemodialysis.com Author Interview: Akiko Kowada, MD, PhDKojiya Haneda Healthcare Service, Ota City Public Health Office, Tokyo, Japan


• The interferon-gamma release assay (IGRA) yields greater benefits at a lower cost than tuberculin skin test and chest x-ray examination for the tuberculosis screening of hemodialysis patients.

• Hemodialysis.com: Were any of the findings unexpected? • The cost-effectiveness was not sensitive to the rates of latent

tuberculosis infection and active tuberculosis in dialysis patients.

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Cost effectiveness of the interferon-γ release assay for tuberculosisscreening of hemodialysis patientsHemodialysis.com Author Interview: Akiko Kowada, MD, PhDKojiya Haneda Healthcare Service, Ota City Public Health Office, Tokyo, Japan (cont)

• Hemodialysis.com: What should clinicians and patients take away from your report? • Clinicians should recommend the IGRA for tuberculosis screening of

hemodialysis patients on the basis of the cost-effectiveness, as wellas its superior sensitivity and specificity, instead of tuberculinskin test and chest x-ray examination.


• Future research is needed to evaluate the results of this costeffectiveness by using the data of prospective cohort studies indialysis patients.

• Reference:• Cost effectiveness of the interferon-γ release assay for tuberculosis screening of

hemodialysis patients Akiko Kowad Nephrol. Dial. Transplant. first published online December 13, 2012 doi:10.1093/ndt/gfs479

















Intravenous ferric carboxymaltose versus standard medical care in the treatment of iron deficiency anemia in patients with chronic kidney disease: a randomized, active-controlled, multi-center study

Hemodialysis.com Author Interview: Chaim Charytan, M.D.

Director, Nephrology, New York Hospital Medical Center of Queens, Flushing, NY, Adjunct Clinical Professor of Medicine at Weill Medical College of Cornell University

• Hemodialysis.com Editor Marie Benz: What are the main findings of the study?• In this study, we evaluated Ferric carboxymaltose (FCM), a stable, iron formulation that does not

contain dextran or dextran derivatives. FCM was developed for rapid IV administration in high doses.

The population studied had either hemodialysis dependent or nondialysis dependent chronic kidney disease (HD-CKD or NDD-CKD).

We provided evidence that rapid administration of FCM in doses of 200 mg for HD-CKD patients and up to 1000 mg in NDD-CKD patients were well tolerated and displayed comparable efficacy to other IV iron formulations.

• Hemodialysis.com: Were any of the findings unexpected? • There were no surprises in this study, in that the results were consistent with other studies

supporting the safety and efficacy of FCM in subjects with Iron Deficiency Anemia in the setting of CKD as well as other clinical settings (including gastrointestinal disease, heavy uterine bleeding, and the postpartum period).

We feel it is important for practitioners to have access to data comparing the safety of this new IV iron formulation (FCM) to other available iron formulations.


Intravenous ferric carboxymaltose versus standard medical care in the treatment of iron deficiency anemia in patients with chronic kidney disease: a randomized, active-controlled, multi-center study

Hemodialysis.com Author Interview: Chaim Charytan, M.D.

Director, Nephrology, New York Hospital Medical Center of Queens, Flushing, NY, Adjunct Clinical Professor of Medicine at Weill Medical College of Cornell University

(cot)

• Hemodialysis.com: What should clinicians and patients take away from your report? • Currently available IV irons vary in indication, dosing regimens and safety profiles. Maximum doses given in a

single visit is limited by the in vivo stability of the iron-carbohydrate moieties.

In addition, the use of IV iron can be limited by anaphylactic reactions.

FCM, a non-dextran iron, was developed for rapid IV administration in high doses and in this study, FCM was well tolerated and efficacious when compared to standard medical care.

• Hemodialysis.com: What recommendations do you have for future research as a result of this study? • Since FCM can be given in high doses, FCM is well suited for outpatient use.

A cost-effectiveness analysis would be interesting since FCM will require fewer clinical visits and venipunctures.

In addition studies evaluating effect on number of transfusion required and patient reported measures of quality of life would be interesting.

• Reference: • Intravenous ferric carboxymaltose versus standard medical care in the treatment of iron deficiency anemia in

patients with chronic kidney disease: a randomized, active-controlled, multi-center study• Nephrol. Dial. Transplant. first published online December 5, 2012 doi:10.1093/ndt/gfs528


Pentraxin 3, a Sensitive Early Marker of Hemodialysis-Induced InflammationHemodialysis.com Author Interview:

Peter Bárány, MD, PhDRenal Medicine, K56

Karolinska University Hospital HuddingeSE–141 86 Stockholm (Sweden)


• Pentraxin 3 (PTX-3) is a sensitive marker of inflammation.

During hemodialysis, PTX-3 start to rise during the first hour and peaks at 180 minutes. The levels of CRP and IL-6 did not change during dialysis and TNF-alpha concentrations decreased.

The effect of changing membrane from low-flux to high-flux or changing from hemodialysis to hemodiafiltration had no significant effect on the intra-dialytic increase in PTX-3 levels.


• The rapid response with increase of PTX-3 during the first hour was not expected.

We believe that this early rise is mediated by release of stored PTX-3 from granulae in the circulating neutrophils.

During repeated HD sessions the individual response was very similar, i.e. the amount of released PTX-3, as estimated by area under the curve of the concentrations, did not change.


Pentraxin 3, a Sensitive Early Marker of Hemodialysis-Induced InflammationHemodialysis.com Author Interview:

Peter Bárány, MD, PhDRenal Medicine, K56

Karolinska University Hospital HuddingeSE–141 86 Stockholm (Sweden)

(cont)

• Hemodialysis.com: What should clinicians and patients take away from your report? • Sensitive methods are necessary to detect hemodialysis-induced inflammatory activity. PTX-

3 is a sensitive marker, but its role in the acute phase response and effect on the vasculature is not clear.


• PTX-3 appears to be a marker of endothelial dysfunction so it may be logical to follow-up with studies of the effect of hemodialysis on the endothelium and the relationship to neutrophil activation and PTX-3 release.

• Reference:• Pentraxin 3, a Sensitive Early Marker of Hemodialysis-Induced Inflammation• Sjöberg B, Qureshi AR, Anderstam B, Alvestrand A, Bárány P.

Divisions of Renal Medicine and Baxter Novum, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden.Blood Purif. 2012 Dec 7;34(3-4):290-297. [Epub ahead of print]

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Hemodialysis.com Research Interviews