Status:
UNKNOWN
The Role of Serotonin in Intensive Care Patients
Lead Sponsor:
Oslo University Hospital
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Brief Summary
Sepsis, cardiac arrest and multiple trauma are potentially life-threatening conditions and common reasons for intensive care unit (ICU) admission. The aim of this study is to investigate the role of t...
Eligibility Criteria
Inclusion
- ICU-PATIENTS
- Inclusion criteria:
- Active treatment of sepsis, septic shock, cardiac arrest with ROSC or severe multiple trauma.
- Age over 18 years
- Written consent from the patient or preliminary consent from the next of kin.
- Receiving mechanical ventilator treatment upon inclusion.
- Arterial and central venous cannulas present.
- Exclusion criteria:
- Withdrawal of consent
- Serotonergic carcinoid syndrome, short bowel or other considerable comorbidity altering serotonin content in blood.
- Intoxication prior to ICU admission.
- HEALTHY CONTROLS
- Inclusion criteria:
- Age over 18 years and signed written consent.
- Conformed to diet and activity restrictions.
- Exclusion criteria:
- Any acute illness or injury
- Ongoing autoimmune, malignant, infectious, or other inflammatory disease.
- Severe psychiatric disease or drug abuse.
- Use of any medication except oral contraceptives last two weeks.
- Withdrawal of consent.
- ICU CONTROLS
- Inclusion criteria:
- Status epilepticus, encephalitis, stroke, or other localized neurological disease.
- Age over 18 years
- Written consent from the patient or preliminary consent from the next of kin.
- Receiving mechanical ventilator treatment upon inclusion.
- Arterial and central venous cannulas present.
- Exclusion criteria:
- Withdrawal of consent
- Clinical signs of infection with focal symptoms or temperature over 38,0°C.
- Biochemical signs of infection or inflammation with leukocytes \> 11 x 10\^9/l, CRP \> 15 mg/l, or PCT \> 0,10 μg/l.
- Respiratory failure with PaO2/FiO2 ratio \< 40 kPa.
- Circulatory failure with MAP \< 60 or need for pressor treatment prior to sedation.
- Thrombocytopenia or thrombocytosis with platelets \< 100 or \> 400 x 10\^9/l.
- Serotonergic carcinoid syndrome, short bowel or other considerable comorbidity altering serotonin content in blood.
- Extracranial autoimmune or malignant disease.
- Severe psychiatric disease or drug abuse.
- Intoxication or physical trauma prior to ICU admission.
Exclusion
Key Trial Info
Start Date :
May 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05386199
Start Date
May 25 2022
End Date
December 31 2024
Last Update
May 31 2022
Active Locations (1)
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1
Oslo University Hospital Ullevål
Oslo, Norway, 0450