Tryptophan, Serotonin and Kynurenine in Septic Shock

Completed

• Conditions: Shock, Septic

• Registration Number: NCT00684736
• Lead Sponsor: Versailles Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2007-04
• Study Completion: 2008-04
• Status Verified: 2008-05
• Study First Submitted: 2008-05-22
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Last Update Submitted: 2008-08-07
• Last Update Posted: 2008-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Kinetics of 5-HT, 5-HIAA, kynurenine, tryptophan, HVA, VMA, DOPAC, Oestradiol, Cotinine and vasopressors	Day-1, Day-2, Day-3, Day-7 and Day-14

Secondary Outcome Measures

Name	Time	Method
Mortality	28-day

Trial Locations

Locations (1)

CH Versailles - André Mignot Hospital; 🇫🇷 Le Chesnay, France