Raymond Poincaré Hospital
Garches, France
Location status: Recruiting
NCT Number: NCT04774705
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 patient's 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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Garches, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A transcutaneous stimulator of the atrial branch of the vagus nerve of the TENS eco Plus type (Schwa-medico) will be used. SNV stimulation will be applied in the concha of the left ear to the subcutaneous area of the atrial branch of the vagus nerve in the left ear (cymba conchae) for each patient, at an intensity of 2 mA, 30 minutes per day for 5 consecutive days, from the day of inclusion / randomization.
For the control group, the stimulation electrode will be inverted so as to deliver the stimulation to the ear lobule.
Time frame: at day 90
Overall death
Time frame: up to day 90
Time frame: up to day 90
Time frame: at day 90
Time frame: at day 90
Time frame: at day 90
Sequential Organ Failure Assessment Score varies from 0 to 4 and permit to assess organ failure. A higher score indicates better neurological function
Time frame: at day 90
Time frame: at inclusion
Time frame: at day 7
Time frame: at day 14
Time frame: at day 21
Time frame: at day 28
Time frame: at day 90
Time frame: at inclusion
Time frame: at day 7
Time frame: at day 14
Time frame: at day 21
Time frame: at day 28
Time frame: at day 90
Time frame: at inclusion
Time frame: at day 7
Time frame: at day 14
Time frame: at day 21
Time frame: at day 28
Time frame: at day 90
Time frame: at inclusion
Time frame: at day 7
Time frame: at day 14
Time frame: at day 21
Time frame: at day 28
Time frame: at day 90
Time frame: at inclusion
Time frame: at day 7
Time frame: at day 14
Time frame: at day 21
Time frame: at day 28
Time frame: at day 90
Time frame: at inclusion
Time frame: at day 7
Time frame: at day 14
Time frame: at day 21
Time frame: at day 28
Time frame: at day 90
Time frame: at inclusion
Time frame: at day 7
Time frame: at day 14
Time frame: at day 21
Time frame: at day 28
Time frame: at day 90
Time frame: at inclusion
Time frame: at day 7
Time frame: at day 28
Overall death
Time frame: at day 90
Neurological fate of patients will evaluated using Glasgow Outcome Scale (GOS)
Contact information is provided by the study sponsor or research team.
Eric AZABOU
CONTACT
Matthieu Resche-Rigon
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Randomized Pilot Study Evaluating the Effectiveness of Non-invasive Vagus Nerve Stimulation as an Adjuvant Treatment in Patients With Sepsis in Intensive Care.
Acronym: SNV-Sepsis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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