the-clinical-need-v2

The Clinical Need

A real-time point of care measurement of renal function has the potential to improve patient outcomes broadly across medical specialties. The unmet need in the critical care environment is well documented. Clinicians throughout the hospital are administering chemotherapy agents, antibiotics and contrast media that can cause kidney damage. Most of these medicines are highly nephrotoxic, and dosing is based on the perceived renal function of the patient.

Currently, there is no real-time point of care GFR measurement technique. This need for a real-time renal function measurement is recognized by the National Institutes for Health and is the subject of an on-going request to the medical research community for a solution.

The optimal solution for a real-time point of care GFR measurement technique will be:

  • Real-time
  • Easy to use
  • Cost-effective

Patient populations impacted would be:

Intensive Care Unit

Treatment of acute kidney injury has been hampered by the inability of a creatinine-based diagnosis to allow clinicians to intervene with timely treatments aimed at preventing further development of the disease to the point where renal replacement therapy is necessary or death occurs.

– Endre et al, Clin Biochem Rev 2011

AKI is a major complication of patients admitted to the ICU, with a mortality of 30-80%.

– Endre et al, Clin Biochem Rev 2011

Acute kidney injury occurs in 4 to 20% of hospitalized patients and in 35 to 75% of critically ill patients in the Intensive Care Unit.

– American Journal of Physiology: Renal Physiology 2011

Chronic Kidney Disease

Patients can lose up to half their kidney function before diagnosis given current tests. Findings highlight the need to identify CKD in its earliest stages to prevent disease progression and avoid the high medical costs attributable to the latter stages of the disease.

– J Am Soc Nephrol 24: 1478–1483, 2013. doi: 10.1681/ASN.2012040392

Approximately 26 million US adults have CKD. CKD growth is expected as the population ages and the prevalence of diabetes and other risks increases among all age groups.

– J Am Soc Nephrol 24: 1478–1483, 2013. doi: 10.1681/ASN.2012040392

Diabetes is on the rise, and so is diabetic nephropathy. Given this epidemic, physicians should consider strategies to detect and control kidney disease in their diabetic patients.

– Cleveland Journal of Medicine, Detecting and controlling diabetic nephropathy: What do we know?. Gerald Appel, MD, Volume 80, Number 4, April 2013

Drug Dosing

Nephrotoxicity is the most important dose-limiting side effect of cisplatin…and occurs in 36% of patients after single doses…

http://www.drugs.com/sfx/cisplatin-side-effects.html

Radiology

The average in-hospital cost of CIN is $10,345. The 1-year cost of treating a patient with CIN is $11,812. Overall, the economic burden associated with CIN is high.

– Subramanian et al, Journal of Medical Economics 10, 119-134, 2007

Contrast-Induced Nephropathy (CI-AKI) is the 3rd most common cause of hospital acquired AKI

– Subramanian et al, Journal of Medical Economics 10, 119-134, 2007

Cardiac Catheterization Lab

Contrast-Induced Nephropathy will occur in 2% to 25% of patients undergoing coronary intervention.

– American Heart Association, December 7, 2010, Contrast-Induced Acute Kidney Injury, Richard Solomon, MD; Harold L. Dauerman, MD

Lengths of stay can be twice as long as the stays of patients without Contrast-Induced Nephropathy, and both inpatient and 30-day mortality can be as much as 10-fold greater.

– CriticalCareNurse Vol 32, No. 6, December 2012

Surgery

In cardiac surgery, rates of kidney injury range between 7.7% and 11.4%.

– Perioperative Risk Assessment, Prevention, and Treatment of Acute Kidney Injury, Sean A. Josephs, MD, Charuhas V. Thakar, MD University of Cincinnati College of Medicine

A temporary decrease in kidney function occurs in approximately 5 to 10 percent of patients undergoing Coronary Artery Bypass Graft (CABG)

www.uptodate.com/contents/coronary-artery-bypass-graft-surgery-beyond-the-basics

Transplants

Early detection of graft dysfunction is paramount in determining reversibility from both medical and surgical complications.

– Surgical Management of the Kidney Transplant Recipient 2012 Kim et al, licensee InTech.

Animal Health

For decades, renal function evaluation in small animal, primary care practice has been limited to measurements of SCr… However, these parameters are insensitive because they are altered only after 60% to 75% loss of renal function.

– Compendium Continuing Education for Veterinarians, Eric H Linnetz, DVM, DACVIM, Thomas K. Graves, DVM, Ph.D, DACVIM, 2010) 2010