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

Malnutrition Clinical Trial

— UREA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911246
• Other study ID #: RC13_0353
• Status: Completed
• Phase: N/A
• First received: September 12, 2016
• Last updated: September 22, 2016
• Start date: December 2014
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: April 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 18 or more

• Admission in ICU

• Estimated length of stay superior to 5 days

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Malnutrition

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 days after admission	No