Evaluation Report of the Urea / Urine Creatinine as a Marker of Nutritional Status Predictive of ICU Care Associated Infections

Completed

• Conditions: Brain Injury; Malnutrition

• Registration Number: NCT02911246
• Lead Sponsor: Nantes University Hospital

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2016-04
• Status Verified: 2016-09
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of infections related to care during stay in intensive care unit	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