Diarrhea and Stipsis in Critically Ill Patients (NUTRITI)

Completed

• Conditions: Nutritional and Metabolic Disease; Enteral Feeding Intolerance; Constipation; Critical Illness; Nutritional Deficiency; ICU Acquired Weakness; Diarrhea
• Interventions: Other: ARTIFICIAL NUTRITION

• Registration Number: NCT05473546
• Lead Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-11
• Primary Completion: 2021-12-31
• Status Verified: 2022-07
• Study Completion: 2022-07-22
• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-07-22
• Last Update Submitted: 2022-07-25
• Study First Posted: 2022-07-26
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRITICALLY ILL PATIENTS	ARTIFICIAL NUTRITION	ADULTS PATIENTS ADMITTED TO ICU DUE TO ACUTE ILLNESS THAT REQUIRE AT LEAST 72H OF STAY. FOR THE FIRST 7 DAYS OF STAY IN ICU, DATA ABOUT NUTRITIONAL INTERVENTION WILL BE RECORDED SUCH AS: ROUTE OF NUTRITION ADMINISTRATION, AMOUNT OF NUTRITION DELIVERED PER DAY, CALORIC TARGETS, PROTEIN REQUIREMENTS, diarrhea, CONSTIPATION, BIA ANALYSIS.

Primary Outcome Measures

Name	Time	Method
FREQUENCY OF diarrhea WITHIN 72 HOURS AFTER ICU ADMISSION	7 DAYS	REGISTER DIARROHEA (EMISSION OF FAECES\> 200 ML IN 24 HOURS) EPISODES

Secondary Outcome Measures

Name	Time	Method
FREQUENCY OF CONSTIPATION WITHIN 7 DAYS AFTER ICU ADMISSION	7 DAYS	REGISTER CONSTIPATION EPISODES WITHIN 7 DAYS AFTER ADMISSION IN ICU
LOSS OF LEAN BODY MASS AFTER 7 DAYS IN ICU	7 DAYS	Loss of at least 7% of lean body mass
CHANGES IN PHASE ANGLE AFTER 7 DAYS IN ICU	7 DAYS	Measure of phase angle

Trial Locations

Locations (1)

Cristian Deana; 🇮🇹 Udine, Italy