Brain InjuryUREANCT02911246
Evaluation Report of the Urea / Urine Creatinine as a Marker of Nutritional Status Predictive of ICU Care Associated Infections
An observational study of Brain Injury and Malnutrition, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Brain Injury, Malnutrition
- How many people
- 309 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in ICU for severe brain injury
Who may be able to join
- 18 or more
- Admission in ICU
- Estimated length of stay superior to 5 days
Who cannot join
- pathologies modifying the ratio of urea / urine creatinine: end stage renal disease ( creatinine clearance less than 15 mL / min), Gastrointestinal bleeding, Right ventricular failure
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
At present, many clinical studies have shown a link between malnutrition and infectious complications in intensive care particularly because of immune disorders.
Many studies testing different nutritional strategies used as the main criterion infectious complications.
So this is a robust standard, well documented in the literature as a reflection of malnutrition in intensive care, and we also want to use in our study.
In a pilot study in the surgical ICU of the Hotel-Dieu report the urea / creatinine urine as a biomarker of poor outcome of nutritional status in the ICU seems extremely discriminating in predicting the existence of nosocomial infection.
Furthermore the kinetics of the relationship between the intake and the 5th day of resuscitation, also appears to be relevant in predicting the occurrence of nosocomial infection.
Surgical ICU of the Hotel-Dieu proposes to conduct a multicenter study to confirm the relationship between the ratio of urea / creatinine urine, malnutrition marker, and nosocomial infections (NI) in intensive care.
Primary objective:
To evaluate the predictability of the ratio of urea / creatinine urinary J5 on the occurrence of nosocomial infection in intensive care.
- Conditions
- Brain Injury, Malnutrition
- Medical subject headings
- Brain Injuries, Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infections related to care during stay in intensive care unit
Six infections assessed are:
- Nosocomial pneumonia and tracheobronchitis
- urinary infection
- surgical site infection
- bacteraemia
- intra-abdominal infection
- Infection of the central nervous system
Measured: 5 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2014
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim Asehnoune, MD PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911246
- Sponsor's protocol ID
- RC13_0353
- Acronym
- UREA
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2016
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Report of the Urea / Urine Creatinine as a Marker of Nutritional Status Predictive of ICU Care Associated Infections
- ClinicalTrials.gov ID
- NCT02911246
- Acronym / sponsor ID
- UREA / RC13_0353
- Conditions
- Brain Injury, Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
At present, many clinical studies have shown a link between malnutrition and infectious complications in intensive care particularly because of immune disorders.
Many studies testing different nutritional strategies used as the main criterion infectious complications.
So this is a robust standard, well documented in the literature as a reflection of malnutrition in intensive care, and we also want to use in our study.
In a pilot study in the surgical ICU of the Hotel-Dieu report the urea / creatinine urine as a biomarker of poor outcome of nutritional status in the ICU seems extremely discriminating in predicting the existence of nosocomial infection.
Furthermore the kinetics of the relationship between the intake and the 5th day of resuscitation, also appears to be relevant in predicting the occurrence of nosocomial infection.
Surgical ICU of the Hotel-Dieu proposes to conduct a multicenter study to confirm the relationship between the ratio of urea / creatinine urine, malnutrition marker, and nosocomial infections (NI) in intensive care.
Primary objective:
To evaluate the predictability of the ratio of urea / creatinine urinary J5 on the occurrence of nosocomial infection in intensive care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in ICU for severe brain injury
Key inclusion criteria (3 listed)
- 18 or more
- Admission in ICU
- Estimated length of stay superior to 5 days
Key exclusion criteria (1 listed)
- pathologies modifying the ratio of urea / urine creatinine: end stage renal disease ( creatinine clearance less than 15 mL / min), Gastrointestinal bleeding, Right ventricular failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of infections related to care during stay in intensive care unit
Time frame: 5 days after admission
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim Asehnoune, MD PhD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury and Malnutrition, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of infections related to care during stay in intensive care unit (time frame: 5 days after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.