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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04774705
Other study ID # D20170804
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 29, 2021
Est. completion date March 29, 2023

Study information

Verified date June 2021
Source Assistance Publique - Hôpitaux de Paris
Contact Eric AZABOU
Phone +331 47 10 79 40
Email eric.azabou@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date March 29, 2023
Est. primary completion date March 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age> 18 years old - Adult man or woman, hospitalized in intensive care, presenting with sepsis for at least 24 hours according to the diagnostic criteria (Singer et al., 2016). Exclusion Criteria: - Patient under guardianship, - Patient in a severe state of agitation. - Patient in a state of brain death or active limitation of treatment. - Multiple trauma patient, with multiple fractures of the skull. - Refusal to participate in the study or to sign the informed consent by the patient or his loved one, - Pregnant or breastfeeding woman, - No affiliation to a social security scheme.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
SNV activ group (Non-invasive transcutaneous stimulation of the vagus nerve )
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.
Placebo group
For the control group, the stimulation electrode will be inverted so as to deliver the stimulation to the ear lobule.

Locations

Country Name City State
France Raymond Poincaré Hospital Garches

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Overall death at day 90
Secondary Cumulative incidence of delirium and its duration up to day 90
Secondary Cumulative incidence of mechanical ventilation and its duration up to day 90
Secondary Proportion of patients having been the subject of a decision to limit or withdraw care at day 90
Secondary Duration of use of vasopressors at day 90
Secondary Number of days alive with a SOFA score <6 at day 90
Secondary Length of stay in intensive care and hospitalization in all patients and in survivors at day 90
Secondary Measurements of changes in C-reactive protein (CRP) at inclusion
Secondary Measurements of changes in C-reactive protein (CRP) at day 7
Secondary Measurements of changes in C-reactive protein (CRP) at day 14
Secondary Measurements of changes in C-reactive protein (CRP) at day 21
Secondary Measurements of changes in C-reactive protein (CRP) at day 28
Secondary Measurements of changes in C-reactive protein (CRP) at day 90
Secondary Measurements of changes in fibrinogen level at inclusion
Secondary Measurements of changes in fibrinogen level at day 7
Secondary Measurements of changes in fibrinogen level at day 14
Secondary Measurements of changes in fibrinogen level at day 21
Secondary Measurements of changes in fibrinogen level at day 28
Secondary Measurements of changes in fibrinogen level at day 90
Secondary Measurements of changes in interleukin-6 (IL-6) at inclusion
Secondary Measurements of changes in interleukin-6 (IL-6) at day 7
Secondary Measurements of changes in interleukin-6 (IL-6) at day 14
Secondary Measurements of changes in interleukin-6 (IL-6) at day 21
Secondary Measurements of changes in interleukin-6 (IL-6) at day 28
Secondary Measurements of changes in interleukin-6 (IL-6) at day 90
Secondary Measurements of changes in interleukin-1ß (IL-1ß) at inclusion
Secondary Measurements of changes in interleukin-1ß (IL-1ß) at day 7
Secondary Measurements of changes in interleukin-1ß (IL-1ß) at day 14
Secondary Measurements of changes in interleukin-1ß (IL-1ß) at day 21
Secondary Measurements of changes in interleukin-1ß (IL-1ß) at day 28
Secondary Measurements of changes in interleukin-1ß (IL-1ß) at day 90
Secondary Measurements of changes in tumor necrosis factor a (TNF-a) at inclusion
Secondary Measurements of changes in tumor necrosis factor a (TNF-a) at day 7
Secondary Measurements of changes in tumor necrosis factor a (TNF-a) at day 14
Secondary Measurements of changes in tumor necrosis factor a (TNF-a) at day 21
Secondary Measurements of changes in tumor necrosis factor a (TNF-a) at day 28
Secondary Measurements of changes in tumor necrosis factor a (TNF-a) at day 90
Secondary Measurements of changes in the calcium binding protein B S100B (S100B) at inclusion
Secondary Measurements of changes in the calcium binding protein B S100B (S100B) at day 7
Secondary Measurements of changes in the calcium binding protein B S100B (S100B) at day 14
Secondary Measurements of changes in the calcium binding protein B S100B (S100B) at day 21
Secondary Measurements of changes in the calcium binding protein B S100B (S100B) at day 28
Secondary Measurements of changes in the calcium binding protein B S100B (S100B) at day 90
Secondary Measurements of changes in the arterial lactate level at inclusion
Secondary Measurements of changes in the arterial lactate level at day 7
Secondary Measurements of changes in the arterial lactate level at day 14
Secondary Measurements of changes in the arterial lactate level at day 21
Secondary Measurements of changes in the arterial lactate level at day 28
Secondary Measurements of changes in the arterial lactate level at day 90
Secondary Characteristics of the EEG at inclusion
Secondary Characteristics of the EEG at day 7
Secondary Mortality rate Overall death at day 28
Secondary Neurological fate of patients Neurological fate of patients will evaluated using Glasgow Outcome Scale - GOS at day 90
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