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Stellate Ganglion Stimulation in Septic Shock to Improve Hemodynamics and Vasopressor Requirements

Award Number: R43GM154625
ORGANIZATION: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/05/2024
PERIOD OF PERFORMANCE END DATE: 01/31/2026

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Stellate Ganglion Stimulation in Septic Shock to Improve Hemodynamics and Vasopressor Requirements - PROJECT SUMMARY: Sepsis is one of the leading sources of morbidity and mortality in the US, impacting nearly 1.7 million adults each year and upwards of 250,000 deaths annually. Septic shock is sepsis characterized by hemodynamic failure, with exceptionally high mortality ranging from 15-70%. Septic shock management involves treatment with antibiotics, fluids, and vasopressor therapy. The latter, while effective at hemodynamic support at high doses, is related to major side-effects including peripheral ischemia leading to injury or loss of extremities (toes, fingers, etc.), kidney injury, liver shock, multiple-organ failure. Thus, it is common that survivors of septic shock have a high degree of morbidity due to these side-effects. The goal of this proposal is to validate a new, minimally invasive approach to producing the beneficial effects of vasopressor therapy without the side-effects. We propose that left stellate ganglion nerve stimulation (SGNS) can be used to aid in hemodynamic support during septic shock, and therefore can markedly reduce, or even obviate, the need for high-dose vasopressor administration. To make this clinically practical, we have developed a novel, minimally invasive percutaneous approach to left stellate ganglion nerve stimulation that is controlled via a closed-loop system that is capable of altering stimulation automatically to changes in hemodynamic and other bio-markers (e.g., arterial pressure, heart rate). This project will be completed in several sequential stages. For this Phase I SBIR we will demonstrate proof of physiological concept that left stellate ganglion nerve stimulation in a known sepsis model can 1) provide and sustain a minimum degree of hemodynamic support (at least 15 mmHg for 30 minutes in mean arterial pressure), 2) that direct SGNS lowers vasopressor requirements compared to control by 50%. Separately, we will show that percutaneous SGNS using our proprietary system is safe, feasible and equivalent to direct SGNS in management of septic shock. Successful completion of the specific aims will lead to the development of a clinical-grade system (stimulator controller and percutaneous lead) that can be validated and verified for Phase II of the project and evaluated clinical in an early feasibility IDE trial.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $274,839 )
2024	2024	CORIDEA LLC	175 CEDAR LN	TEANECK	NJ	07666	BERGEN	USA	Biomedical Research and Research Training	000	1	6/5/2024	NEW	$274,839
														Subtotal = $274,839

Grand Total All Awards = $274,839

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Stellate Ganglion Stimulation in Septic Shock to Improve Hemodynamics and Vasopressor Requirements

Award Number: R43GM154625

ORGANIZATION: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/05/2024

PERIOD OF PERFORMANCE END DATE: 01/31/2026

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