Preventing Cardiac Surgery AKI

CSA-AKI is a huge burden to patients and the entire healthcare system 1

CSA-AKI is associated with reduced blood flow and oxygen deprivation that comes with cardiac surgery. While cardiac surgery has over a 95% success rate, collateral damage to the kidneys is observed in one third of procedures. 2
2-6 days
longer ICU recovery with CS-AKI2
7-13 days
longer hospital stay2
15% vs. 1.4%
mortality rate with and without AKI2
>30%
mortality rate if RRT is needed2

Current standard of care involves manually logging urine output

The standard of care has limited efficacy in preventing CS-AKI as current protocols involve passive monitoring of urine output in collection bags, then compensating with IV fluids. This process is labor-intensive and it frequently allows for intervention only after the damage is done. Industry guidelines to improve AKI outcomes, such as KDIGO, have shown insufficient results: a mere 10% improvement3. The system uniquely responds to minute fluctuations in urine production and output, automatically adjusting the administration of IV fluids in milliliter increments. The patient remains hemodynamically stable, preventing both over- and under-hydration. The device is comprised of a Console and a Single Use Set for infusion and urine collection. Its straightforward interface allows seamless integration into the clinical workflow after brief training.
AKI is defined by CMS as a“Hospital Harm” that requires monitoring and reporting, starting 2025 4

RenalPro closes the loop in renal care by automatically balancing the fluids into and out of the kidneys

RenalPro Therapy is groundbreaking because it autonomously bundles fluid management and therapeutic systems that elegantly integrate into the clinical workflow. The system is unique in its ability to respond to minute fluctuations in the production and output of urine, automatically adjusting the administration of IV fluids in milliliter increments. The patient is kept hemodynamically stable, preventing over- or under-hydration.

Cardiac Surgery Clinical Evidence: 52% less AKI than control in UK study 5

In a validation trial at the Heart & Lung Centre in Wolverhampton, UK:

  • 220-patient (on-pump) randomized, controlled clinical study

  • 110 patients in each arm
RENALPRO THERAPY

Key Features

Fully automated

accurately balancing urine output with hydration

Timely intervention

Real-time monitoring enables timely intervention

Seamless integration

Seamless integrates into current workflow

Granted

FDA Breakthrough Device Designation

Validated

Validated in clinical study and endorsed

  1. Warren et. al. Incidence and impact of acute kidney injury in patients with acute coronary syndromes treated with coronary artery bypass grafting: American Heart Journal 2016:171,1:40-47 https://doi.org/10.1016/j.ahj.2015.07.001
  2. Hu et al. Global Incidence & Outcomes of Adult Patients With AKI after Cardiac Surgery: A Systematic Review & Meta-Analysis. Cardiothorac Vasc Anesth. 2016;30:82-9 > 320,000 patients. Lau D, et al. Costs & consequences of AKI after cardiac surgery: A cohort study. J Thorac Cardiovasc Surg. 2021;162:880https://pubmed.ncbi.nlm.nih.gov/32299694/-887
  3. Current standard of care is based on the KDIGO guidelines, which suffer from poor compliance, due to complexity, and provide only minimal reduction in AKI. (PrevAKI Study). Potential Reno-protective Strategies in Cardiac Surgery. J Cardiothorac Vasc Anesth. (2021) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9933995/.
  4. CMS Announces Addition of Hospital Harm-AKI to Medicare’s Inpatient Quality Reporting (IQR) program
  5. Heyman Luckraz et. al, Reduction in acute kidney injury post cardiac surgery using balanced forced diuresis: a randomized, controlled trial, European Journal of Cardio-Thoracic Surgery, Volume 59, Issue 3, March 2021. https://academic.oup.com/ejcts/article/59/3/562/6000632