The Role of Serotonin in Intensive Care Patients

NCT ID: NCT05386199

Last Updated: 2022-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-25

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sepsis Septic Shock Cardiac Arrest With Successful Resuscitation Multiple Trauma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy controls

Healthy volunteers without conditions altering serotonin content in blood.

No interventions assigned to this group

Sepsis group

Patients with sepsis or septic shock admitted to ICU and receiving mechanical ventilation.

No interventions assigned to this group

Cardiac arrest group

Patients with cardiac arrest and ROSC admitted to ICU and receiving mechanical ventilation.

No interventions assigned to this group

Multiple trauma group

Patients with severe multiple trauma admitted to ICU and receiving mechanical ventilation.

No interventions assigned to this group

ICU control group

Patients with isolated neurological disease admitted to ICU and receiving mechanical ventilation.

No interventions assigned to this group

Eligibility Criteria

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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.


* Age over 18 years and signed written consent.
* Conformed to diet and activity restrictions.


* 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
* Serotonergic carcinoid syndrome, short bowel or other considerable comorbidity altering serotonin content in blood.
* Intoxication prior to ICU admission.

HEALTHY CONTROLS


* 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


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Morten Rostrup

Senior physician and clinical professor, Department of Acute Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Morten Rostrup, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital, University of Oslo

Locations

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Oslo University Hospital Ullevål

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Morten Rostrup, MD PhD

Role: CONTACT

+4722119338

Nikolai R Aarskog, MD

Role: CONTACT

+4722119338

Facility Contacts

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Morten Rostrup, MD PhD

Role: primary

+4722119338

Nikolai R Aarskog, MD

Role: backup

+4722119338

Other Identifiers

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REK366749

Identifier Type: -

Identifier Source: org_study_id

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