Diarrhea and Stipsis in Critically Ill Patients (NUTRITI)
NUTRITI
Gastrointestinal Complications of Artificial Nutrition in ICU: a Prospective Observational Study (NUTRITI)
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedFirst Submitted
Initial submission to the registry
July 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2022
CompletedFirst Posted
Study publicly available on registry
July 26, 2022
CompletedJuly 27, 2022
July 1, 2022
2.2 years
July 22, 2022
July 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
FREQUENCY OF diarrhea WITHIN 72 HOURS AFTER ICU ADMISSION
REGISTER DIARROHEA (EMISSION OF FAECES\> 200 ML IN 24 HOURS) EPISODES
7 DAYS
Secondary Outcomes (3)
FREQUENCY OF CONSTIPATION WITHIN 7 DAYS AFTER ICU ADMISSION
7 DAYS
LOSS OF LEAN BODY MASS AFTER 7 DAYS IN ICU
7 DAYS
CHANGES IN PHASE ANGLE AFTER 7 DAYS IN ICU
7 DAYS
Study Arms (1)
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.
Interventions
Eligibility Criteria
ADULTS ICU CRITICALLY ILL PATIENTS REQUIRING ICU ADMISSION DUE TO ACUTE ILLNESS WITH ANTICIPATED ICU STAY \> 72 HOURS AND NEEDING ARTIFICIAL NUTRITION
You may qualify if:
- ICU ANTICIPATED LENGTH OF STAY \> 72 HOURS
- AGE \> 18 YEARS
- NEED FOR ARTIFICIAL NUTRITION
You may not qualify if:
- AGE \< 18 YEARS
- ICU ANTICIPATED LENGTH OF STAY \< 72 HOURS
- NO NEED FOR ARTIFICIAL NUTRITION
- BMI\<16 KG/M2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cristian Deana
Udine, 33100, Italy
Related Publications (1)
Danielis M, Mattiussi E, Piani T, Iacobucci A, Tullio A, Molfino A, Vetrugno L, Deana C; Nutriti Study Group. Diarrhoea and constipation during artificial nutrition in intensive care unit: A prospective observational study. Clin Nutr ESPEN. 2023 Oct;57:375-380. doi: 10.1016/j.clnesp.2023.07.007. Epub 2023 Jul 20.
PMID: 37739681DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
CRISTIAN DEANA, MD
Health Integrated Agency of Friuli Centrale, via Pozzuolo 330, 33100 Udine, Italy
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 22, 2022
First Posted
July 26, 2022
Study Start
October 11, 2019
Primary Completion
December 31, 2021
Study Completion
July 22, 2022
Last Updated
July 27, 2022
Record last verified: 2022-07