Link Between Plasma Citrulline and Lipopolysaccharide Concentrations in the Critically Ill

Critically Ill Clinical Trial

— CITRANS  

Official title:

Link Between Plasma Citrulline and Lipopolysaccharide Concentrations in the Critically Ill

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02902276
• Other study ID #: P/2016/187
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2016
• Last updated: September 14, 2016
• Start date: July 2016
• Est. completion date: February 2017

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Gaël Piton, MD, PhD
• Phone: 0033381668224
• Email: gpiton[@]chu-besancon.fr
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

In critically ill patients, the small bowel permeability is increased, leading to bacterial translocation, and systemic inflammatory response syndrome.

Plasma citrulline is a validated biomarker of functional enterocyte mass. Lipopolysaccharide (LPS) is a part of Gram negative bacteria, and plasma LPS concentration is a biomarker of bacterial translocation. The link between plasma citrulline and LPS in the critically ill is unknown. Investigators hypothesize that patients presenting with low plasma citrulline concentration, with presumed altered small bowel function, would have an increased phenomenon of bacterial translocation, and increased plasma LPS concentration. Investigators aimed to evaluate the link between plasma citrulline and LPS concentrations in critically ill patients at the time of ICU admission.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Critically ill patients requiring ICU admission for at least 48 hours

• Adults

Exclusion Criteria:

• Chronic small bowel disease

• Chronic renal failure (clearance of creatinine < 50 mL/min)

• Pregnancy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

Other:
• additional blood sample
Two blood samples will be taken at ICU admission

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma citrulline concentration	biological assay	Up to 12 hours after admission in the unit	No
Primary	plasma lipopolysaccharide concentration	biological assay	Up to 12 hours after admission in the unit	No