Status:
COMPLETED
Tryptophan, Serotonin and Kynurenine in Septic Shock
Lead Sponsor:
Versailles Hospital
Conditions:
Shock, Septic
Eligibility:
All Genders
18+ years
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 metabolis...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00684736
Start Date
June 1 2004
End Date
April 1 2008
Last Update
August 8 2008
Active Locations (1)
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1
CH Versailles - André Mignot Hospital
Le Chesnay, France, 78150