The Role of Serotonin in Intensive Care Patients

Sepsis Clinical Trial

— SERO-22  

Official title:

The Role of Serotonin in Respiratory and Circulatory Failure in Intensive Care Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05386199
• Other study ID #: REK366749
• Status: Recruiting
• Start date: May 25, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2022
• Source: Oslo University Hospital
• Contact: Morten Rostrup, MD PhD
• Phone: +4722119338
• Email: morteros[@]uio.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Arrest With Successful Resuscitation
• Multiple Trauma
• Sepsis
• Septic Shock

Locations

Country	Name	City	State
Norway	Oslo University Hospital Ullevål	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma 5-HIAA	5-hydroxyindoleacetic acid in plasma	As soon as possible after ICU admission. No more than 3 days after admission.
Other	Plasma 5-HIAA	5-hydroxyindoleacetic acid in plasma	End of first week at ICU, an average of 5 days after admission.
Other	Urine 5-HIAA	5-hydroxyindoleacetic acid in urine	As soon as possible after ICU admission. No more than 3 days after admission.
Other	Urine 5-HIAA	5-hydroxyindoleacetic acid in urine	End of first week at ICU, an average of 5 days after admission.
Primary	PPP-serotonin	Serotonin in platelet poor plasma	As soon as possible after ICU admission. No more than 3 days after admission.
Secondary	PPP-serotonin	Serotonin in platelet poor plasma	End of first week at ICU, an average of 5 days after admission.
Secondary	Platelet serotonin	Serotonin in platelets	As soon as possible after ICU admission. No more than 3 days after admission.
Secondary	Platelet serotonin	Serotonin in platelets	End of first week at ICU, an average of 5 days after admission.