NCT02902276

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

August 11, 2016

Last Update Submit

September 14, 2016

Conditions

Keywords

plasma citrullinelipopolysaccharidecritically illHospitalization in an Intensive Care Unit

Outcome Measures

Primary Outcomes (2)

  • Plasma citrulline concentration

    biological assay

    Up to 12 hours after admission in the unit

  • plasma lipopolysaccharide concentration

    biological assay

    Up to 12 hours after admission in the unit

Interventions

Two blood samples will be taken at ICU admission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients requiring ICU admission for at least 48 hours, without chronic small bowel disease, without chronic renal failure (usual clearance of creatinine \< 50 mL/min), not pregnant.

You may qualify if:

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

You may not qualify if:

  • Chronic small bowel disease
  • Chronic renal failure (clearance of creatinine \< 50 mL/min)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Besançon

Besançon, 25030, France

RECRUITING

Related Publications (1)

  • Chaignat C, Lagrost L, Moretto K, de Barros JP, Winiszewski H, Grober J, Saas P, Piton G. Plasma citrulline concentration and plasma LPS detection among critically ill patients a prospective observational study. J Crit Care. 2024 Feb;79:154438. doi: 10.1016/j.jcrc.2023.154438. Epub 2023 Oct 3.

Biospecimen

Retention: SAMPLES WITHOUT DNA

2000 microliters of plasma will be stored at -80°C for future analyses (lipopolysaccharide concentration, cytokines).

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gaël Piton, MD, PhD

    CHU Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaël Piton, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

September 15, 2016

Study Start

July 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

September 15, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations