NCT02911246

Brief Summary

Malnutrition is defined by an energy supply deficit, protein, macro-molecules or micro-nutrients, resulting from an imbalance between nutrient intakes and metabolic needs of the body. It concerns 40 to 60% of patients upon entry into resuscitation and influences their prognosis. Studies over the past decade have shown that nutritional deficiency increases the morbidity and mortality in intensive care. Several clinical and biological parameters were evaluated as markers of malnutrition, including the ratio of urea / urine creatinine. The report would identify patients in a state of malnutrition, to optimize their nutritional care. This setting is easy to obtain in all patients by simple urine collection unlike other clinical and biological criteria of resuscitation malnutrition assessment. This ratio of urea / urien creatinine would optimize energy intake of critically ill patients, for which nutritional management methods are widely debated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
309

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
Last Updated

June 24, 2026

Status Verified

September 1, 2016

Enrollment Period

Same day

First QC Date

September 12, 2016

Last Update Submit

June 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of infections related to care during stay in intensive care unit

    Six infections assessed are: 1. Nosocomial pneumonia and tracheobronchitis 2. urinary infection 3. surgical site infection 4. bacteraemia 5. intra-abdominal infection 6. Infection of the central nervous system

    5 days after admission

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in ICU for severe brain injury

You may qualify if:

  • or more
  • Admission in ICU
  • Estimated length of stay superior to 5 days

You may not qualify if:

  • pathologies modifying the ratio of urea / urine creatinine: end stage renal disease ( creatinine clearance less than 15 mL / min), Gastrointestinal bleeding, Right ventricular failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Brain InjuriesMalnutrition

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Karim Asehnoune, MD PhD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 22, 2016

Study Start

December 1, 2014

Primary Completion

December 1, 2014

Study Completion

April 1, 2016

Last Updated

June 24, 2026

Record last verified: 2016-09

Locations