The Role of Serotonin in Intensive Care Patients

Study Overview
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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.

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

Conditions
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Sepsis, Septic Shock, Cardiac Arrest With Successful Resuscitation, Multiple Trauma

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy controls<br>Healthy volunteers without conditions altering serotonin content in blood. | |
| Sepsis group<br>Patients with sepsis or septic shock admitted to ICU and receiving mechanical ventilation. | |
| Cardiac arrest group<br>Patients with cardiac arrest and ROSC admitted to ICU and receiving mechanical ventilation. | |
| Multiple trauma group<br>Patients with severe multiple trauma admitted to ICU and receiving mechanical ventilation. | |
| ICU control group<br>Patients with isolated neurological disease admitted to ICU and receiving mechanical ventilation. | |

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serotonin, 5-hydroxytryptamine, 5-HT, 5-hydroxyindoleacetic acid, 5-HIAA, Platelet poor plasma-serotonin, PPP-serotonin