Diarrhea and Stipsis in Critically Ill Patients (NUTRITI)

• Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine (Other)
• Overall Status: Completed
• CT.gov ID: NCT05473546
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 33.3
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness; Nutritional and Metabolic Disease; Nutritional Deficiency; ICU Acquired Weakness; Enteral Feeding Intolerance; Diarrhea; Constipation	Other: ARTIFICIAL NUTRITION

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Gastrointestinal Complications of Artificial Nutrition in ICU: a Prospective Observational Study (NUTRITI)
• Actual Study Start Date: Oct 11, 2019
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Jul 22, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. FREQUENCY OF CONSTIPATION WITHIN 7 DAYS AFTER ICU ADMISSION [7 DAYS]

   REGISTER CONSTIPATION EPISODES WITHIN 7 DAYS AFTER ADMISSION IN ICU

2. LOSS OF LEAN BODY MASS AFTER 7 DAYS IN ICU [7 DAYS]

   Loss of at least 7% of lean body mass

3. CHANGES IN PHASE ANGLE AFTER 7 DAYS IN ICU [7 DAYS]

   Measure of phase angle

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cristian Deana	Udine		Italy	33100

Sponsors and Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine

Investigators

• Principal Investigator: CRISTIAN DEANA, MD, Health Integrated Agency of Friuli Centrale, via Pozzuolo 330, 33100 Udine, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cristian Deana, Principal Investigator, Azienda Sanitaria-Universitaria Integrata di Udine
• ClinicalTrials.gov Identifier: NCT05473546
• Other Study ID Numbers: NUTRITI
• First Posted: Jul 26, 2022
• Last Update Posted: Jul 27, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Diseases; Malnutrition; Constipation; Diarrhea; Critical Illness

Study Results

No Results Posted as of Jul 27, 2022