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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Metabolic and Nutritional Characteristics of Long-stayer ICU Patients

Clinicaltrials.gov identifier NCT03938961

Recruitment Status Completed

First Posted May 6, 2019

Last update posted April 14, 2020

Study Description

Brief summary:

The intensive care (ICU) patient population has increasing number of very long ICU stays. Long-stayers are usually defined as requiring more than 1 week of mechanical ventilation and of ICU therapy: little is know about their metabolic characteristics and their relation to outcome. The study aims at describing the demographic, nutritional and metabolic aspects of their stay. Analysis of 200-250 consecutive patients admitted to the ICU long-stayer program.

  • Condition or Disease:Critically Ill
  • Intervention/Treatment:
  • Phase: N/A
Detailed Description

Data extracted from the computerized ICU system (PDMS): age, Simplified acute physiology score (SAPSII), weight, BMI, Nutrition Risk Score (NRS-2002), daily energy, protein, and glucose intakes, Energy balance, blood glucose (dysglycemia and Glu variability) and lactate, 24hr-insulin (Goal Glu 6-8 mmol/l). Outcome variables: length of stay (LICU), muscle strength (MRC), vital status at 90 days. Patients will be followed in detail until ICU discharge and for vital status until day 90 after admission Data will be presented as mean or median, univariate and multivariate analysis will be performed.

Study Design
  • Study Type: Observational [Patient Registry]
  • Actual Enrollment: 205 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Long-stayer Critically Ill Patients: is the Metabolic and Nutritional Therapy in the ICU Creating the Problem?
  • Actual Study Start Date: February 2017
  • Actual Primary Completion Date: April 2020
  • Actual Study Completion Date: April 2020
Outcome Measures
  • Primary Outcome Measures: 1. Vital Status [ Time Frame: up to 90 days ]
    Alive or dead at 90 days after ICU admission
  • Secondary Outcome Measures: 1. Force [ Time Frame: up to 90 days ]
    Muscle strength measured by Medical research Council (MRC) score
  • Other Outcome Measures: 1. Decubitus ulcer [ Time Frame: up to 90 days ]
    Appearance of decubitus ulcer during ICU stay
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Critically ill patients who required more than 2 weeks of ICU treatment, and who have entered the ICU's long stayer program
Criteria

Inclusion Criteria:

- ICU length of stay > 7 days and enrollment to the long-stayer ICU program

Exclusion Criteria:

- Major burns

- Brain injury

- Severe neurological condition as primary disease

Contacts and Locations
Contacts
Locations

Switzerland, Vaud
Adult ICU and Burns, University of Lausanne Hospital
Lausanne

Sponsors and Collaborators

Centre Hospitalier Universitaire Vaudois

More Information