Tryptophan, Serotonin and Kynurenine in Septic Shock (TSK)

This study has been completed.
Sponsor:
Information provided by:
Central Hospital, Versailles
ClinicalTrials.gov Identifier:
NCT00684736
First received: May 22, 2008
Last updated: August 7, 2008
Last verified: May 2008
  Purpose

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.


Condition
Shock, Septic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tryptophan, Serotonin and Kynurenine in Septic Shock

Resource links provided by NLM:


Further study details as provided by Central Hospital, Versailles:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 28-day ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: June 2004
Study Completion Date: April 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who were 18 years of age or older and had been hospitalized in our ICU were prospectively enrolled in the study if they met all eligibility criteria. Inclusion criteria were clinical evidence of infection, evidence of a systemic response to infection, and the onset of shock within the previous 3 hours.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684736

Locations
France
CH Versailles - André Mignot Hospital
Le Chesnay, France, 78150
Sponsors and Collaborators
Central Hospital, Versailles
Investigators
Study Chair: Jean-Pierre Bédos, MD, PhD Central Hospital, Versailles
Study Director: Odile Spreux-Varoquaux, PhD Central Hospital, Versailles
Principal Investigator: Matthieu Henry-Lagarrigue, MD Central Hospital, Versailles
  More Information

No publications provided

Responsible Party: Henry-Lagarrigue Matthieu/MD, Intensive Care Unit
ClinicalTrials.gov Identifier: NCT00684736     History of Changes
Other Study ID Numbers: TSK Sepsis
Study First Received: May 22, 2008
Last Updated: August 7, 2008
Health Authority: France: French Data Protection Authority
France: Institutional Ethical Committee
France: Ministry of Health
France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by Central Hospital, Versailles:
septic shock
shock
serotonin
kynurenine
tryptophan

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Serotonin
Tryptophan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014