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Tryptophan, Serotonin and Kynurenine in Septic Shock

NCT ID: NCT00684736

Last Updated: 2008-08-08

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

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-06-30

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Shock, Septic

Keywords

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septic shock shock serotonin kynurenine tryptophan

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Versailles Hospital

OTHER

Sponsor Role lead

Responsible Party

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Intensive Care Unit

Principal Investigators

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Jean-Pierre Bédos, MD, PhD

Role: STUDY_CHAIR

Versailles Hospital

Odile Spreux-Varoquaux, PhD

Role: STUDY_DIRECTOR

Versailles Hospital

Matthieu Henry-Lagarrigue, MD

Role: PRINCIPAL_INVESTIGATOR

Versailles Hospital

Locations

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CH Versailles - André Mignot Hospital

Le Chesnay, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 32384433 (View on PubMed)

Other Identifiers

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TSK Sepsis

Identifier Type: -

Identifier Source: org_study_id