Critical Illness Clinical Trial
— NUTRITIOfficial title:
Gastrointestinal Complications of Artificial Nutrition in ICU: a Prospective Observational Study (NUTRITI)
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 |
Verified date | July 2022 |
Source | Azienda Sanitaria-Universitaria Integrata di Udine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Cristian Deana | Udine |
Lead Sponsor | Collaborator |
---|---|
Azienda Sanitaria-Universitaria Integrata di Udine |
Italy,
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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