Shock, SepticTSKNCT00684736
Tryptophan, Serotonin and Kynurenine in Septic Shock
An observational study of Shock, Septic, run by Versailles Hospital at 1 site in France.
Trial summary
Septic shock is a major cause of mortality and morbidity worldwide. Serotonin (5-HT) is released by activated platelets into the circulation, and is mediator of endothelial dysfunction. 5-HT metabolism is known in immune system via specific 5-HT receptor, also in effects on the peripheral nervous system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Septic
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2004to Apr 2008
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were 18 years of age or older and had been hospitalized in our ICU were prospectively enrolled in the study if they met all eligibility criteria. Inclusion criteria were clinical evidence of infection, evidence of a systemic response to infection, and the onset of shock within the previous 3 hours.
Who may be able to join
- Age above or equal to 18 years
- Strong presumption clinical sepsis
- Need for mechanical ventilation
- Body temperature above 38°C or below 36°C
- Heart rate above 90 bpm
- Systolic blood pressure of <90mm Hg despite adequate fluid replacement or a need for vasopressors less than 3 hours
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- Presence of at least one of the following criteria:
- Ratio of arterial oxygen tension over inspired fraction of oxygen of less than 300 mm Hg
- Urinary output below 0.5 mL per kg of bodyweight per h or below 30 mL/h (for at least 1 h)
- Arterial lactate concentration above 2 mmol/L
- Consent signed
- Patient who receive before inclusion one of the following treatment known to modify serotonin level: almotriptan, amitriptyline, amoxapine, citalopram, clomipramine, clozapine, desipramine, dihydroergotamine, dolasetron, dosulepin, doxepin, eletriptan, ergotamine, flunarizine, fluoxetine, fluvoxamine, granisetron, imipramine, indoramin, interferon Alfa, interferon alfacon-1, interferon beta, iproniazid, maprotiline, methysergide, mianserin, Milnacipran, mirtazapine, moclobemide, naratriptan, olanzapine, ondansetron, oxetorone, paroxetine, pizotifen, risperidone, sertraline, sumatriptan, tianeptine, trimipramine, tropisetron, venlafaxine,viloxazine, zolmitriptan.
- No consent
Who cannot join
- Age below 18 years
- Pregnancy
- Underlying disease with a poor prognosis, a life expectancy of less than 24 hours
- Depression or melancholy
- Neuropsychiatric diseases: Seizure, manic psychosis, Migraine, or Drug addiction
- Neuroendocrine tumors
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- Obstructive cardiomyopathy or acute myocardial ischaemia
- Pulmonary embolism
- Advanced stage cancer, malignant haemopathy, or AIDS with a decision to withhold or withdraw aggressive therapies
Trial locations and contacts
1 site in 1 country.
About this study
Septic shock is a major cause of mortality and morbidity worldwide. Serotonin (5-HT) is released by activated platelets into the circulation, and is mediator of endothelial dysfunction. 5-HT metabolism is known in immune system via specific 5-HT receptor, also in effects on the peripheral nervous system. Kinetic of 5-HT, tryptophan, kynurenine, MAO activity and IDO activity in human septic shock was never investigated.
- Conditions
- Shock, Septic
- Keywords
- septic shock, shock, serotonin, kynurenine, tryptophan
- Medical subject headings
- Shock, Septic, Shock
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinetics of 5-HT, 5-HIAA, kynurenine, tryptophan, HVA, VMA, DOPAC, Oestradiol, Cotinine and vasopressors
Measured: Day-1, Day-2, Day-3, Day-7 and Day-14
Secondary outcomes (1)
Mortality
Measured: 28-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startJun 2004
- Primary completionApr 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shock, SepticStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Pierre Bédos, MD, PhD, Study chair, Versailles HospitalOdile Spreux-Varoquaux, PhD, Study director, Versailles HospitalMatthieu Henry-Lagarrigue, MD, Principal investigator, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684736
- Sponsor's protocol ID
- TSK Sepsis
- Acronym
- TSK
- Status last verified
- May 2008
- First submitted
- 22 May 2008
- Last updated
- 8 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Troche G, Henry-Lagarrigue M, Soppelsa F, Legriel S, Yehia A, Bruneel F, Bedos JP, Spreux-Varoquaux O. Tryptophan pathway catabolites (serotonin, 5-hydroxyindolacetic acid, kynurenine) and enzymes (monoamine oxidase and indole amine 2,3 dioxygenase) in patients with septic shock: A prospective observational study versus healthy controls. Medicine (Baltimore). 2020 May;99(19):e19906. doi: 10.1097/MD.0000000000019906.
PubMed 32384433
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tryptophan, Serotonin and Kynurenine in Septic Shock
- ClinicalTrials.gov ID
- NCT00684736
- Acronym / sponsor ID
- TSK / TSK Sepsis
- Conditions
- Shock, Septic
- Keywords
- septic shock, shock, serotonin, kynurenine, tryptophan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 28 May 2008 (estimated)
- 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.
Septic shock is a major cause of mortality and morbidity worldwide. Serotonin (5-HT) is released by activated platelets into the circulation, and is mediator of endothelial dysfunction. 5-HT metabolism is known in immune system via specific 5-HT receptor, also in effects on the peripheral nervous system. Kinetic of 5-HT, tryptophan, kynurenine, MAO activity and IDO activity in human septic shock was never investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were 18 years of age or older and had been hospitalized in our ICU were prospectively enrolled in the study if they met all eligibility criteria. Inclusion criteria were clinical evidence of infection, evidence of a systemic response to infection, and the onset of shock within the previous 3 hours.
Key inclusion criteria (13 listed)
- Age above or equal to 18 years
- Strong presumption clinical sepsis
- Need for mechanical ventilation
- Body temperature above 38°C or below 36°C
- Heart rate above 90 bpm
Key exclusion criteria (9 listed)
- Age below 18 years
- Pregnancy
- Underlying disease with a poor prognosis, a life expectancy of less than 24 hours
- Depression or melancholy
- Neuropsychiatric diseases: Seizure, manic psychosis, Migraine, or Drug addiction
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
Kinetics of 5-HT, 5-HIAA, kynurenine, tryptophan, HVA, VMA, DOPAC, Oestradiol, Cotinine and vasopressors
Time frame: Day-1, Day-2, Day-3, Day-7 and Day-14
1 secondary outcome
Mortality
Time frame: 28-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2008.
- Derived from this study: PubMed 32384433Troche G, Henry-Lagarrigue M, Soppelsa F, Legriel S, Yehia A, Bruneel F, Bedos JP, Spreux-Varoquaux O. Tryptophan pathway catabolites (serotonin, 5-hydroxyindolacetic acid, kynurenine) and enzymes (monoamine oxidase and indole amine 2,3 dioxygenase) in patients with septic shock: A prospective observational study versus healthy controls. Medicine (Baltimore). 2020 May;99(19):e19906. doi: 10.1097/MD.0000000000019906.
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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.
Jean-Pierre Bédos, MD, PhD study chair
Versailles Hospital
Odile Spreux-Varoquaux, PhD study director
Versailles Hospital
Matthieu Henry-Lagarrigue, MD principal investigator
Versailles Hospital
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 Shock, Septic, run by Versailles Hospital at 1 site in France.
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 13 inclusion and 9 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: finished, as of the sponsor's last update on 8 Aug 2008. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinetics of 5-HT, 5-HIAA, kynurenine, tryptophan, HVA, VMA, DOPAC, Oestradiol, Cotinine and vasopressors (time frame: Day-1, Day-2, Day-3, Day-7 and Day-14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00684736, which also lists 1 linked publication.
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 8 Aug 2008.