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CompletedNCT00684736TSKUpdated Aug 8, 2008

Tryptophan, Serotonin and Kynurenine in Septic Shock

An observational study in Shock, Septic, sponsored by Versailles Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-08-08.

Sponsored by Versailles Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
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Study 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. Kinetic of 5-HT, tryptophan, kynurenine, MAO activity and IDO activity in human septic shock was never investigated.

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Conditions studied

  • Shock, Septic

Keywords

  • septic shock
  • shock
  • serotonin
  • kynurenine
  • tryptophan
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In context

Shock, Septic

862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 298 observational studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Versailles Hospital is the lead sponsor of 74 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Eligibility criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • Obstructive cardiomyopathy or acute myocardial ischaemia
  • Pulmonary embolism
  • Advanced stage cancer, malignant haemopathy, or AIDS with a decision to withhold or withdraw aggressive therapies
  • Inclusion in another clinical trial
  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Mortality

    Time frame: 28-day

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Study locations

1 site
  • CH Versailles - André Mignot Hospital
    Le Chesnay, 78150, France
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00684736
Lead sponsor
Versailles Hospital
First posted
May 28, 2008
Start date
Jun 2004
Primary completion
Apr 2007
Completion
Apr 2008
Last update
Aug 8, 2008

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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