Status:
COMPLETED
Adjunctive Sedation With Dexmedetomidine for the Prevention of Severe Inflammation and Septic Encephalopathy
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Sepsis-Associated Encephalopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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 attending physician, participant or substitute decision maker is not committed to active treatment
- Women who are pregnant or breast feeding
- Known or suspected non-compliance, drug or severe alcohol abuse
- Inability of the participant to understand the procedures of the study, e.g. due to language problems, psychological disorders, or dementia
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04076826
Start Date
September 1 2019
End Date
July 8 2022
Last Update
February 13 2023
Active Locations (1)
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1
Inselspital, Bern University Hospital
Bern, Switzerland, 3010