Clinical Evidence

To get an understanding of how our products and therapies can help in your clinic, take time to review our clinical evidence library. Our clinical evidence pieces include: posters, presentations, and clinical summaries.
Decreased patient survival when ultrafiltration rates rise above 6.8 mL/h/kg threshold.
Blood Purification. 2017. Chazot C, Vo-Van C, Lorriaux C, et al.
Increased risk of all-cause patient mortality when ultrafiltration rates rise above 8 mL/kg/h.
American Journal of Kidney Disease. 2016. Assimon MM, Wenger JB, Wang L, Flythe JE.
Not achieving dry weight is associated with a higher risk of all-cause and cardiovascular mortality when compared to ultrafiltration rates and interdialytic weight gain.
American Journal of Nephrology. 2013. Movilli E, Camerini C, Gaggia P, et al.
Ultrafiltration rates > 13 mL/kg/h were associated with increased all-cause mortality and CV mortality.
Kidney International. 2011. Flythe J, Kimmel S, Brunelli S.
More frequent and longer hemodialysis treatments are associated with significant improvements in left ventricular mass and health-related quality of life.
Journal of the American Medical Association. 2007. Culleton B, Walsh M, Klarenbach SW, et al.
Significant reduction in left ventricular mass and blood pressure in patients prescribed nocturnal hemodialysis.
Kidney International. 2002. Chan CT, Floras JS, Miller JA, Richardson RMA, Pierratos A.

Risks and Responsibilities
The reported benefits of home hemodialysis (HHD) may not be experienced by all patients.

The NxStage System is a prescription device and, like all medical devices, involves some risks. The risks associated with hemodialysis treatments in any environment include, but are not limited to, high blood pressure, fluid overload, low blood pressure, heart-related issues, and vascular access complications. When vascular access is exposed to more frequent use, infection of the site, and other access related complications may also be potential risks. The medical devices used in hemodialysis therapies may add additional risks including air entering the bloodstream, and blood loss due to clotting or accidental disconnection of the blood tubing set.

Home hemodialysis with the NxStage System during waking hours may not require a care partner, provided a physician and a qualified patient agree that solo home hemodialysis is appropriate. Patients performing nocturnal treatments are required to have a care partner. Care partners are trained on proper operation and how to get medical or technical help if needed.

Certain risks associated with hemodialysis treatment are increased when performing solo HHD because no one is present to help the patient respond to health emergencies. If patients experience needles coming out, blood loss, or very low blood pressure during solo HHD, they may lose consciousness or become physically unable to correct the health emergency. Losing consciousness or otherwise becoming impaired during any health emergency while alone could result in significant injury or death. Additional ancillary devices and training are required when performing solo HHD.

Certain risks associated with hemodialysis treatment are increased when performing nocturnal therapy due to the length of treatment time and because therapy is performed while the patient and care partner are sleeping. These risks include, but are not limited to, blood access disconnects and blood loss during sleep, blood clotting due to slower blood flow and/or increased treatment time, and delayed response to alarms when waking from sleep.

Patients should consult their doctor to understand the risks and responsibilities of performing these therapies using the NxStage System.

References

  1. Weinhandl ED et al. Survival in Daily Home Hemodialysis and Matched Thrice-Weekly In-Center Hemodialysis Patients. J Am Soc Nephrol. 23: 895–904, 2012.
  2. Jaber BL, Lee Y, Collins AJ, et al. Effect of daily hemodialysis on depressive symptoms and post-dialysis recovery time: interim report from the FREEDOM (Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements) Study. Am J Kidney Dis. 2010;56(3):531-539.
  3. Finkelstein FO et al. At-home short daily hemodialysis improves the long-term health-related quality of life. Kidney International. (2012) 82, 561–569
Prolonged Intermittent Renal Replacement Therapy (PIRRT) provides adequate volume in and solute control in acute patients, while allowing for staffing flexibility
American Journal of Kidney Diseases. 2008. Gashti CN, Salcedo S, Robinson, V, Rodby, RA.
Dosing Guidelines developed by Bruce Mueller, PharmD et al., for 8 and 10 hour renal replacement therapy for the treatment of critically ill patients receiving 8 - 10 hour RRT
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Fluconazole dosing recommendations for patients receiving 8 and 10 hour prolonged intermittent renal replacement therapy
Clinical Nephrology. 2016. Gharibian, KN, Mueller BA.
Meropenem, imipenem, doripenem dosing recommendations for patients receiving 8 and 10 hour prolonged intermittent renal replacement therapy
Journal of Clinical Pharmacology. 2016. Lewis SJ, Kays MB, Mueller BA.
Evaluation of the probability of target attainment of various ciprofloxacin and levofloxacin regimens in critically ill patients receiving 8 and 10 hour Prolonged Intermittent Renal Replacement Therapy
Renal Replacement Therapy. 2016. Lewis SJ, Chaijamorn W, Shaw AR, Mueller BA.
Cefepime, ceftazidime, and piperacillin/tazobactam dosing recommendations for patients receiving prolonged intermittent renal replacement therapy
The Journal of Clinical Pharmacology. 2018. Jang SM, Gharibian KN, Lewis SJ, Fissell WH, Tolwani AJ, Mueller BA.
Vancomycin dosing recommendations for patients receiving prolonged intermittent renal Replacement therapy
SAGE Open Medicine. 2018. Lewis SJ, Mueller BA.
Gentamicin dosing recommendations for patients receiving prolonged intermittent renal Replacement therapy
The 21st International Conference on Advances in Critical Care Nephrology, AKI & CRRT. 2016. Li J, Lewis SJ, Gharibian KN, Mueller BA.