Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04774705
Status:
RECRUITING
Last Update Posted:
2021-06-24
First Post:
2021-02-24
Brief Title:
Effectiveness of Non-invasive Vagus Nerve Stimulation as an Adjuvant Treatment in Patients With Sepsis in Intensive Care
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Randomized Pilot Study Evaluating the Effectiveness of Non-invasive Vagus Nerve Stimulation as an Adjuvant Treatment in Patients With Sepsis in Intensive Care
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SNV-Sepsis
Brief Summary:
Sepsis is one of the leading causes of death in intensive care About 50 of patients with septic shock die after 1 year and 50 of survivors suffer from cognitive decline The pathophysiological mechanisms of serious complications of sepsis are now well known In fact the systemic inflammation related to sepsis amplifies the release of pro-inflammatory cytokines and neurotoxic mediators hence an increase in deleterious phenomena such as oxidative stress mitochondrial dysfunction endothelial activation disruption of the blood-brain barrier neuroinflammation astrocytic and microglial activation leading to multi-organ failure which compromises the patients vital and functional prognosis Although there has been progress in the understanding of its pathophysiology the management of sepsis and septic shock in intensive care relies mainly on anti-infective treatments and the restoration of cardiovascular and respiratory functions There is virtually no adjuvant therapy for the management of sepsis apart from a few hormonal therapies such as insulin to maintain blood glucose levels below 180 mg dL and low doses of corticosteroids and vasopressin There is therefore a pressing need to develop innovative treatments targeting inflammatory and immunological processes in order to reduce the complications of sepsis and improve patient prognosis Some recent work has shown that electrical vagus nerve stimulation SNV a technique used for the treatment of drug-resistant epilepsy can modulate inflammatory and immune responses and control inflammation syndrome in animal models of sepsis arthritis and rheumatism in humans In this pilot study the investigators plan to evaluate the efficacy of transcutaneous non-invasive SNV as an adjuvant treatment in patients with sepsis in intensive care
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None