Tryptophan, Serotonin and Kynurenine in Septic Shock (TSK)

August 7, 2008 updated by: Versailles Hospital
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Chesnay, France, 78150
        • CH Versailles - André Mignot Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day-1, Day-2, Day-3, Day-7 and Day-14

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 28-day
28-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Versailles Hospital

Investigators

  • Study Chair: Jean-Pierre Bédos, MD, PhD, Versailles Hospital
  • Study Director: Odile Spreux-Varoquaux, PhD, Versailles Hospital
  • Principal Investigator: Matthieu Henry-Lagarrigue, MD, Versailles Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (ACTUAL)

April 1, 2007

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

May 22, 2008

First Submitted That Met QC Criteria

May 27, 2008

First Posted (ESTIMATE)

May 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 8, 2008

Last Update Submitted That Met QC Criteria

August 7, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSK Sepsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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