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Completed

NCT Number: NCT05473546

Diarrhea and Stipsis in Critically Ill Patients (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.

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Key information

Conditions

Critical Illness Constipation Diarrhea Disease Attributes Enteral Feeding Intolerance ICU Acquired Weakness Malnutrition Metabolic Diseases Nutrition Disorders Nutritional Deficiency Nutritional and Metabolic Disease Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cristian Deana

Udine, 33100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARTIFICIAL NUTRITION

Other

ARTIFICIAL NUTRITION

Primary outcomes

  1. FREQUENCY OF diarrhea WITHIN 72 HOURS AFTER ICU ADMISSION

    Time frame: 7 DAYS

    REGISTER DIARROHEA (EMISSION OF FAECES> 200 ML IN 24 HOURS) EPISODES

Secondary outcomes

  1. FREQUENCY OF CONSTIPATION WITHIN 7 DAYS AFTER ICU ADMISSION

    Time frame: 7 DAYS

    REGISTER CONSTIPATION EPISODES WITHIN 7 DAYS AFTER ADMISSION IN ICU

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

    Time frame: 7 DAYS

    Loss of at least 7% of lean body mass

  3. CHANGES IN PHASE ANGLE AFTER 7 DAYS IN ICU

    Time frame: 7 DAYS

    Measure of phase angle

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria-Universitaria Integrata di Udine

Other

Registry information

Official study title

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

Acronym: NUTRITI

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 26, 2022
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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