The Role of Serotonin in Intensive Care Patients (SERO-22)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Septic Shock; Multiple Trauma; Cardiac Arrest With Successful Resuscitation

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Morten Rostrup, MD PhD; Phone Number: +4722119338; Email: morteros@uio.no
• Study Contact Backup: Name: Nikolai R Aarskog, MD; Phone Number: +4722119338; Email: n.r.aarskog@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway, 0450
    • Recruiting
    • Oslo University Hospital Ullevål
    • Contact: Morten Rostrup, MD PhD; Phone Number: +4722119338; Email: morteros@uio.no
    • Contact: Nikolai R Aarskog, MD; Phone Number: +4722119338; Email: n.r.aarskog@medisin.uio.no
    • Sub-Investigator: Aleksander R Holten, MD PhD
    • Sub-Investigator: Knut Erik Hovda, MD PhD
    • Sub-Investigator: Geir Øystein Andersen, MD PhD
    • Sub-Investigator: Vibeke N Kjær
    • Sub-Investigator: Eirik Qvigstad, MD PhD
    • Sub-Investigator: Kjetil Sunde, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Healthy controls; Healthy volunteers without conditions altering serotonin content in blood.
Sepsis group; Patients with sepsis or septic shock admitted to ICU and receiving mechanical ventilation.
Cardiac arrest group; Patients with cardiac arrest and ROSC admitted to ICU and receiving mechanical ventilation.
Multiple trauma group; Patients with severe multiple trauma admitted to ICU and receiving mechanical ventilation.
ICU control group; Patients with isolated neurological disease admitted to ICU and receiving mechanical ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PPP-serotonin	Serotonin in platelet poor plasma	As soon as possible after ICU admission. No more than 3 days after admission.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PPP-serotonin	Serotonin in platelet poor plasma	End of first week at ICU, an average of 5 days after admission.
Platelet serotonin	Serotonin in platelets	As soon as possible after ICU admission. No more than 3 days after admission.
Platelet serotonin	Serotonin in platelets	End of first week at ICU, an average of 5 days after admission.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma 5-HIAA	5-hydroxyindoleacetic acid in plasma	As soon as possible after ICU admission. No more than 3 days after admission.
Plasma 5-HIAA	5-hydroxyindoleacetic acid in plasma	End of first week at ICU, an average of 5 days after admission.
Urine 5-HIAA	5-hydroxyindoleacetic acid in urine	As soon as possible after ICU admission. No more than 3 days after admission.
Urine 5-HIAA	5-hydroxyindoleacetic acid in urine	End of first week at ICU, an average of 5 days after admission.

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Morten Rostrup, MD PhD, Oslo University Hospital, University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Serotonin; 5-HT; 5-hydroxytryptamine; 5-hydroxyindoleacetic acid; 5-HIAA; Platelet poor plasma-serotonin; PPP-serotonin
• Additional Relevant MeSH Terms: Wounds and Injuries; Multiple Trauma
• Other Study ID Numbers: REK366749

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No