The Role of Serotonin in Intensive Care Patients

NCT05386199 | Unknown

• 1 other identifier: REK366749
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• PPP-serotonin

  Serotonin in platelet poor plasma

  As soon as possible after ICU admission. No more than 3 days after admission.

Secondary Outcomes (3)

• PPP-serotonin

  End of first week at ICU, an average of 5 days after admission.

• Platelet serotonin

  As soon as possible after ICU admission. No more than 3 days after admission.

• Platelet serotonin

  End of first week at ICU, an average of 5 days after admission.

Other Outcomes (4)

• Plasma 5-HIAA

  As soon as possible after ICU admission. No more than 3 days after admission.

• Plasma 5-HIAA

  End of first week at ICU, an average of 5 days after admission.

• Urine 5-HIAA

  As soon as possible after ICU admission. No more than 3 days after admission.

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Arterial and central venous cannulas present.

You may not qualify if:

• Withdrawal of consent
• Serotonergic carcinoid syndrome, short bowel or other considerable comorbidity altering serotonin content in blood.
• Intoxication prior to ICU admission.
• HEALTHY CONTROLS
• Age over 18 years and signed written consent.
• Conformed to diet and activity restrictions.
• 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
• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital Ullevål

Oslo, 0450, Norway

RECRUITING

MeSH Terms

Conditions

Sepsis; Shock, Septic; Multiple Trauma

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Wounds and Injuries

Study Officials

• Morten Rostrup, MD PhD

  Oslo University Hospital, University of Oslo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morten Rostrup, MD PhD

CONTACT

+4722119338; morteros@uio.no

Nikolai R Aarskog, MD

CONTACT

+4722119338; n.r.aarskog@medisin.uio.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician and clinical professor, Department of Acute Medicine

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 23, 2022
• Study Start: May 25, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

NO (1)