Breath Ammonia Measurements for Dialysis Assessment

我们建议，呼吸氨是一个替代措施氮废物负荷的患者的血液患有终末期肾脏疾病。我们从一项有限的研究中提出了人体呼吸的初步红外光谱数据，该研究有n=7例接受肾脏透析的患者。在治疗开始和结束期间，呼吸氨浓度从大约2000ppb+/- 10%下降到大约200ppb+/-10%。我们展示了通过分析每次呼吸测量时采集的血液样本确定的血液尿素氮（BUN：约90mg/dL至约30mg/dL）和肌酐（约14mg/dL至约5mg/dL）的降低之间的相关性。我们建议在I期将研究扩大到n=50例患者，以1)验证使用呼吸氨作为BUN和肌酐的替代测量，2)改进呼吸收集和光谱方法，3)进一步小型化光谱仪。我们将利用I期研究结果设计一项n等于或bbbb500的II期患者研究，以获得FDA对光谱仪的批准，并将该系统设计成一个足够小的包装，以便1)并入透析机中，以持续地原位评估透析疗效；2)用于ESRD患者和有ESRD风险的患者（如糖尿病和高血压患者）的家中。建议的商业应用：为每个肾透析患者和肾病学家提供透析治疗进展和效率的即时测量。用定期呼吸测量代替目前使用的不频繁的血检，以确定何时开始和停止治疗。将仪器集成到透析机中进行原位分析。美国市场：22万名透析患者每周接受3次透析，相当于每年3432万次透析，无痛评估和筛查糖尿病患者、高血压患者和有潜在肾/肝问题的早产儿的健康状况。美国市场每年有200万人

We propose that breath ammonia is a surrogate measure of nitrogenous waste loading in the blood of patients suffering from End Stage Renal Disease. We present preliminary infrared spectroscopic data of human breath from a limited study of n=7 patients undergoing kidney dialysis. Breath ammonia concentration drops from approximately 2000ppb+/- 10% to approximately 200ppb+/-10% between the beginning and the end of the treatment session. We show correlations with reductions in blood urea nitrogen (BUN: approximately 90mg/dL to approximately 30mg/dL) and creatinine (approximately 14mg/dL to approximately 5mg/dL) determined by assaying blood samples taken at every breath measurement. We propose in Phase I to expand the study to n=50 patients to 1) validate the use of breath ammonia as a surrogate measure of BUN and creatinine, 2) refine breath collection and spectroscopic methods, 3) further miniaturize the spectrometer. We will use the Phase I results to design an n equal to or > 500 Phase II patient study to obtain FDA Approval of the spectrometer and to engineer the system into a package small enough to be 1) incorporated into dialysis machines for continuous in-situ assessment of dialysis efficacy and 2) used in the homes of ESRD patients and those at risk of ESRD, such as diabetics and hypertensives. PROPOSED COMMERCIAL APPLICATIONS: Provide every kidney dialysis patient and nephrologist with an instantaneous measure of the progress and efficiency of dialysis treatment. Substitute regular breath measurement for currently-used infrequent blood panels to determine when to begin and stop treatment. Integrate instrument into dialysis machines for in-situ analysis. U.S. Market: >220,000 dialysis patients treated 3 times per week corresponding to 34.32 million dialysis sessions per year Painlessly assess and screen the well-being of diabetics, hypertensives, and premature babies with potential kidney/liver trouble. U.S. Market > 2,000,000 individuals per year