Clinical trial NCT05386199: The Role of Serotonin in Intensive Care Patients
Official title: The Role of Serotonin in Respiratory and Circulatory Failure in Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Septic Shock
Cardiac Arrest With Successful Resuscitation
Multiple Trauma
Keywords: Serotonin
5-hydroxytryptamine
5-HT
5-hydroxyindoleacetic acid
5-HIAA
Platelet poor plasma-serotonin
PPP-serotonin
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sepsis or septic shock, cardiac arrest with ROSC or severe multiple trauma, admitted to ICU and receiving mechanical ventilation will be screened for inclusion. A group of healthy controls will also be included.

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 the signaling substance serotonin in blood in these conditions.


Eligibility criteria: 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.

Primary outcomes:
measure: PPP-serotonin
timeFrame: As soon as possible after ICU admission. No more than 3 days after admission.
Secondary outcomes:
measure: PPP-serotonin
timeFrame: End of first week at ICU, an average of 5 days after admission.
measure: Platelet serotonin
timeFrame: As soon as possible after ICU admission. No more than 3 days after admission.
measure: Platelet serotonin
timeFrame: End of first week at ICU, an average of 5 days after admission.
Other outcomes:
measure: Plasma 5-HIAA
timeFrame: As soon as possible after ICU admission. No more than 3 days after admission.
measure: Plasma 5-HIAA
timeFrame: End of first week at ICU, an average of 5 days after admission.
measure: Urine 5-HIAA
timeFrame: As soon as possible after ICU admission. No more than 3 days after admission.
measure: Urine 5-HIAA
timeFrame: End of first week at ICU, an average of 5 days after admission.
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital Ullevål
Study officials:
affiliation: Oslo University Hospital, University of Oslo
name: Morten Rostrup, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: