Adjunctive Sedation With Dexmedetomidine for the Prevention of Severe Inflammation and Septic Enc… (NCT04076826) | Clinical Trial Compass
CompletedNot Applicable
Adjunctive Sedation With Dexmedetomidine for the Prevention of Severe Inflammation and Septic Encephalopathy
Switzerland70 participantsStarted 2019-09-01
Plain-language summary
Septic encephalopathy (SE) is defined as acute cerebral dysfunction in patients with sepsis or septic shock. SE occurs in up to 50% of critically ill patients with sepsis and is associated with a high mortality and morbidity. The pathophysiology of SE is complex and involves increased levels of inflammatory mediators such as tumor necrosis factor (TNF)-α, Interleukin (IL)-1 and IL-6, leading to blood brain barrier dysfunction and neuronal inflammation. Several biomarkers of neuronal injury have been proposed to identify patients with SE. Of these biomarkers, S100-β has the highest sensitivity and specificity.
Sedation with Dexmedetomidine (DEX) is a promising strategy for the management of these patients, as DEX has been shown to decrease the production of inflammatory mediators in experimental models of sepsis. In clinical studies, DEX lowers the incidence of delirium and critical illness polyneuropathy. However, its effectiveness in treatment and prevention of SE remains unclear.
The aim of the present study is to investigate the effect of two standard sedation protocols (Dexmedetomidine sedation vs. Propofol / Midazolam) on serum markers of SE in critically ill patients with sepsis who require sedation and mechanical ventilation.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* The participant is aged 18 years or older
* The participant has been intubated and is receiving mechanical ventilation
* The participant requires sedative medication for comfort, safety or to facilitate the delivery of life support measures
* The participant has either a central venous or an arterial catheter inserted within 24 hours of admission
* The participant has a diagnosis of sepsis based on the recent SEPSIS-3 consensus clinical criteria.
Exclusion Criteria:
* Age \< 18 years
* The treating physician believes that the participant will remain intubated for \<24 hours or the participant has been intubated for diagnostic or therapeutic procedures as the sole reason for mechanical ventilation.
* Participants with any of the following admission diagnosis: acute cerebral vascular event, traumatic brain injury, epilepsy, hypoxic brain injury, meningitis, encephalitis
* Participants with history of melanoma (S 100-β is elevated in melanoma participants)
* Participants with schizophrenia or other chronic psychiatric conditions
* Admission for drug overdose
* Planned administration of ongoing neuromuscular blockade
* Heart rate \< 55 / min or an atrioventricular block \> grade 2a in the absence of a functioning pacemaker
* Known hypersensitivity or allergy to any of the sedative medications used in this study.
* DNR (do not resuscitate) or DNI (do not intubate) orders
* Death is deemed to be imminent or inevitable during this admission and either the at…