Diarrhea and Stipsis in Critically Ill Patients (NUTRITI) (NUTRITI)

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Constipation; Diarrhea; ICU Acquired Weakness; Enteral Feeding Intolerance; Nutritional Deficiency; Nutritional and Metabolic Disease
• Intervention / Treatment: Other: ARTIFICIAL NUTRITION

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Italy
  • Udine, Italy, 33100
    • Cristian Deana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ADULTS ICU CRITICALLY ILL PATIENTS REQUIRING ICU ADMISSION DUE TO ACUTE ILLNESS WITH ANTICIPATED ICU STAY > 72 HOURS AND NEEDING ARTIFICIAL NUTRITION

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CRITICALLY ILL PATIENTS; 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.	Other: ARTIFICIAL NUTRITION; ARTIFICIAL NUTRITION

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FREQUENCY OF diarrhea WITHIN 72 HOURS AFTER ICU ADMISSION	REGISTER DIARROHEA (EMISSION OF FAECES> 200 ML IN 24 HOURS) EPISODES	7 DAYS

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 11, 2019
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): July 22, 2022

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (ACTUAL): July 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Signs and Symptoms, Digestive; Nutrition Disorders; Diarrhea; Constipation; Critical Illness; Malnutrition; Metabolic Diseases
• Other Study ID Numbers: NUTRITI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No