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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00684736 |
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Date of registration:
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22/05/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Tryptophan, Serotonin and Kynurenine in Septic Shock
TSK |
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Scientific title:
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Tryptophan, Serotonin and Kynurenine in Septic Shock |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00684736 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Odile Spreux-Varoquaux, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Central Hospital, Versailles |
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Name:
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Jean-Pierre Bédos, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Central Hospital, Versailles |
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Name:
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Matthieu Henry-Lagarrigue, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Central Hospital, Versailles |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Shock, Septic
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Mortality
[Time Frame: 28-day]
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Secondary ID(s)
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TSK Sepsis
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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