Tryptophan, Serotonin and Kynurenine in Septic Shock

Shock, Septic Clinical Trial

— TSK  

Official title:

Tryptophan, Serotonin and Kynurenine in Septic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684736
• Other study ID #: TSK Sepsis
• Status: Completed
• Phase: N/A
• First received: May 22, 2008
• Last updated: August 7, 2008
• Start date: June 2004
• Est. completion date: April 2008

Study information

• Verified date: May 2008
• Source: Central Hospital, Versailles
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection AuthorityFrance: Institutional Ethical CommitteeFrance: Ministry of HealthFrance: National Consultative Ethics Committee for Health and Life Sciences
• Study type: Observational

Clinical 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. Kinetic of 5-HT, tryptophan, kynurenine, MAO activity and IDO activity in human septic shock was never investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Shock
• Shock, Septic

Locations

Country	Name	City	State
France	CH Versailles - André Mignot Hospital	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Versailles

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mortality		28-day	Yes