SepsisSERO-22NCT05386199
The Role of Serotonin in Intensive Care Patients
An observational study of Sepsis and Septic Shock, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Septic Shock, Cardiac Arrest With Successful Resuscitation
- How many people
- 250 participants
- Where
- 1 siteNorway
- Study dates
- 25 May 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital Ullevål
Oslo, 0450
Morten Rostrup, MD PhD, +4722119338, morteros@uio.no
Nikolai R Aarskog, MD, +4722119338, n.r.aarskog@medisin.uio.no
About this study
Official title: 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.
- Keywords
- Serotonin, 5-hydroxytryptamine, 5-HT, 5-hydroxyindoleacetic acid, 5-HIAA, Platelet poor plasma-serotonin, PPP-serotonin
- Medical subject headings
- Sepsis, Shock, Septic, Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
PPP-serotonin
Serotonin in platelet poor plasma
Measured: As soon as possible after ICU admission. No more than 3 days after admission.
Secondary outcomes (3)
PPP-serotonin
Serotonin in platelet poor plasma
Measured: End of first week at ICU, an average of 5 days after admission.
Platelet serotonin
Serotonin in platelets
Measured: As soon as possible after ICU admission. No more than 3 days after admission.
Platelet serotonin
Serotonin in platelets
Measured: End of first week at ICU, an average of 5 days after admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start25 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Rostrup, Oslo University Hospital
- Investigators
- Morten Rostrup, MD PhD, Principal investigator, Oslo University Hospital, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386199
- Sponsor's protocol ID
- REK366749
- Acronym
- SERO-22
- Status last verified
- May 2022
- First submitted
- 6 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Serotonin in Respiratory and Circulatory Failure in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT05386199
- Acronym / sponsor ID
- SERO-22 / REK366749
- Keywords
- Serotonin, 5-hydroxytryptamine, 5-HT, 5-hydroxyindoleacetic acid, 5-HIAA, Platelet poor plasma-serotonin, PPP-serotonin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PPP-serotonin
Time frame: As soon as possible after ICU admission. No more than 3 days after admission.
Serotonin in platelet poor plasma
3 secondary outcomes
PPP-serotonin
Time frame: End of first week at ICU, an average of 5 days after admission.
Platelet serotonin
Time frame: As soon as possible after ICU admission. No more than 3 days after admission.
Platelet serotonin
Time frame: End of first week at ICU, an average of 5 days after admission.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
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CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Rostrup, MD PhD principal investigator
Oslo University Hospital, University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morten Rostrup, MD PhD (+4722119338, morteros@uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPP-serotonin (time frame: As soon as possible after ICU admission. No more than 3 days after admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.