Tryptophan, Serotonin and Kynurenine in Septic Shock

NCT00684736 | Completed

• 1 other identifier: TSK Sepsis
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Shock, Septic

Keywords

septic shock; shock; serotonin; kynurenine; tryptophan

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Mortality

  28-day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• No consent

Sponsors & Collaborators

• Versailles Hospital: lead

Study Sites (1)

CH Versailles - André Mignot Hospital

Le Chesnay, 78150, France

Location

Related Publications (1)

• Troche G, Henry-Lagarrigue M, Soppelsa F, Legriel S, Yehia A, Bruneel F, Bedos JP, Spreux-Varoquaux O. Tryptophan pathway catabolites (serotonin, 5-hydroxyindolacetic acid, kynurenine) and enzymes (monoamine oxidase and indole amine 2,3 dioxygenase) in patients with septic shock: A prospective observational study versus healthy controls. Medicine (Baltimore). 2020 May;99(19):e19906. doi: 10.1097/MD.0000000000019906.

  PMID: 32384433 DERIVED

MeSH Terms

Conditions

Shock, Septic; Shock

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Pierre Bédos, MD, PhD

  Versailles Hospital

  STUDY CHAIR

• Odile Spreux-Varoquaux, PhD

  Versailles Hospital

  STUDY DIRECTOR

• Matthieu Henry-Lagarrigue, MD

  Versailles Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 28, 2008
• Study Start: June 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2008
• Last Updated: August 8, 2008

Record last verified: 2008-05

Locations

FR (1)