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.
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
