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NCT05473546 Clinical Trial

Diarrhea and Stipsis in Critically Ill Patients (NUTRITI)

Critical Illness Clinical Trial

— NUTRITI  

Official title:
Gastrointestinal Complications of Artificial Nutrition in ICU: a Prospective Observational Study (NUTRITI)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05473546
Other study ID # NUTRITI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 11, 2019
Est. completion date July 22, 2022

Study information
Verified date July 2022
Source Azienda Sanitaria-Universitaria Integrata di Udine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study prospectively observed the complications intended as diarrhea or sti-sis that critically ill patients developed within 7 days after ICU admission. In addition, secondary aims investigated through bioimpedenziometry the loss of lean body mass and changes in phase angle during the same period of ICU stay.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date July 22, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - ICU ANTICIPATED LENGTH OF STAY > 72 HOURS - AGE > 18 YEARS - NEED FOR ARTIFICIAL NUTRITION Exclusion Criteria: - AGE < 18 YEARS - ICU ANTICIPATED LENGTH OF STAY < 72 HOURS - NO NEED FOR ARTIFICIAL NUTRITION - BMI<16 KG/M2

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• ARTIFICIAL NUTRITION
ARTIFICIAL NUTRITION

Locations
Country Name City State
Italy Cristian Deana Udine

Sponsors (1)
Lead Sponsor Collaborator
Azienda Sanitaria-Universitaria Integrata di Udine

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary FREQUENCY OF diarrhea WITHIN 72 HOURS AFTER ICU ADMISSION REGISTER DIARROHEA (EMISSION OF FAECES> 200 ML IN 24 HOURS) EPISODES 7 DAYS
Secondary FREQUENCY OF CONSTIPATION WITHIN 7 DAYS AFTER ICU ADMISSION REGISTER CONSTIPATION EPISODES WITHIN 7 DAYS AFTER ADMISSION IN ICU 7 DAYS
Secondary LOSS OF LEAN BODY MASS AFTER 7 DAYS IN ICU Loss of at least 7% of lean body mass 7 DAYS
Secondary CHANGES IN PHASE ANGLE AFTER 7 DAYS IN ICU Measure of phase angle 7 DAYS
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