Critical IllnessNUTRITINCT05473546
Diarrhea and Stipsis in Critically Ill Patients (NUTRITI)
An observational study of Critical Illness and Nutritional and Metabolic Disease, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Nutritional and Metabolic Disease, Nutritional Deficiency
- What is being tested?
- ARTIFICIAL NUTRITION
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 11 Oct 2019to 22 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ADULTS ICU CRITICALLY ILL PATIENTS REQUIRING ICU ADMISSION DUE TO ACUTE ILLNESS WITH ANTICIPATED ICU STAY > 72 HOURS AND NEEDING ARTIFICIAL NUTRITION
Who may be able to join
- ICU ANTICIPATED LENGTH OF STAY > 72 HOURS
- AGE > 18 YEARS
- NEED FOR ARTIFICIAL NUTRITION
Who cannot join
- AGE < 18 YEARS
- ICU ANTICIPATED LENGTH OF STAY < 72 HOURS
- NO NEED FOR ARTIFICIAL NUTRITION
- BMI<16 KG/M2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Critical Illness, Nutritional and Metabolic Disease, Nutritional Deficiency, ICU Acquired Weakness, Enteral Feeding Intolerance, Diarrhea
- Being tested
- ARTIFICIAL NUTRITION
- Medical subject headings
- Critical Illness, Metabolic Diseases, Malnutrition, Diarrhea, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTIFICIAL NUTRITIONOther
ARTIFICIAL NUTRITION
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ARTIFICIAL NUTRITION |
What is being measured
The primary outcome is the main question the study is designed to answer.
FREQUENCY OF diarrhea WITHIN 72 HOURS AFTER ICU ADMISSION
REGISTER DIARROHEA (EMISSION OF FAECES> 200 ML IN 24 HOURS) EPISODES
Measured: 7 DAYS
Secondary outcomes (3)
FREQUENCY OF CONSTIPATION WITHIN 7 DAYS AFTER ICU ADMISSION
REGISTER CONSTIPATION EPISODES WITHIN 7 DAYS AFTER ADMISSION IN ICU
Measured: 7 DAYS
LOSS OF LEAN BODY MASS AFTER 7 DAYS IN ICU
Loss of at least 7% of lean body mass
Measured: 7 DAYS
CHANGES IN PHASE ANGLE AFTER 7 DAYS IN ICU
Measure of phase angle
Measured: 7 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start11 Oct 2019
- Primary completion31 Dec 2021
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristian Deana, Azienda Sanitaria-Universitaria Integrata di Udine
- Investigators
- CRISTIAN DEANA, MD, Principal investigator, Health Integrated Agency of Friuli Centrale, via Pozzuolo 330, 33100 Udine, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473546
- Sponsor's protocol ID
- NUTRITI
- Acronym
- NUTRITI
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37739681
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Complications of Artificial Nutrition in ICU: a Prospective Observational Study (NUTRITI)
- ClinicalTrials.gov ID
- NCT05473546
- Acronym / sponsor ID
- NUTRITI / NUTRITI
- Conditions
- Critical Illness, Nutritional and Metabolic Disease, Nutritional Deficiency, ICU Acquired Weakness, Enteral Feeding Intolerance, Diarrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di UdineUniversity, hospital or other
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRITICALLY ILL PATIENTS | – | Other: ARTIFICIAL NUTRITIONADULTS 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ADULTS ICU CRITICALLY ILL PATIENTS REQUIRING ICU ADMISSION DUE TO ACUTE ILLNESS WITH ANTICIPATED ICU STAY > 72 HOURS AND NEEDING ARTIFICIAL NUTRITION
Key inclusion criteria (3 listed)
- ICU ANTICIPATED LENGTH OF STAY > 72 HOURS
- AGE > 18 YEARS
- NEED FOR ARTIFICIAL NUTRITION
Key exclusion criteria (4 listed)
- AGE < 18 YEARS
- ICU ANTICIPATED LENGTH OF STAY < 72 HOURS
- NO NEED FOR ARTIFICIAL NUTRITION
- BMI<16 KG/M2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARTIFICIAL NUTRITIONARTIFICIAL NUTRITION | Other | CRITICALLY ILL PATIENTS |
Primary outcome
FREQUENCY OF diarrhea WITHIN 72 HOURS AFTER ICU ADMISSION
Time frame: 7 DAYS
REGISTER DIARROHEA (EMISSION OF FAECES> 200 ML IN 24 HOURS) EPISODES
3 secondary outcomes
FREQUENCY OF CONSTIPATION WITHIN 7 DAYS AFTER ICU ADMISSION
Time frame: 7 DAYS
LOSS OF LEAN BODY MASS AFTER 7 DAYS IN ICU
Time frame: 7 DAYS
CHANGES IN PHASE ANGLE AFTER 7 DAYS IN ICU
Time frame: 7 DAYS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Derived from this study: PubMed 37739681Danielis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CRISTIAN DEANA, MD principal investigator
Health Integrated Agency of Friuli Centrale, via Pozzuolo 330, 33100 Udine, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Nutritional and Metabolic Disease, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FREQUENCY OF diarrhea WITHIN 72 HOURS AFTER ICU ADMISSION (time frame: 7 DAYS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05473546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.