Metabolic and Nutritional Characteristics of Long-stayer ICU Patients (Nutri-ICU-LS)

Long-stayer Critically Ill Patients: is the Metabolic and Nutritional Therapy in the ICU Creating the Problem?

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.

Study Overview

• Status: Completed
• Conditions: Critically Ill

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 Type: Observational
• Enrollment (Actual): 205

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Adult ICU and Burns, University of Lausanne Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital Status	Alive or dead at 90 days after ICU admission	up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Force	Muscle strength measured by Medical research Council (MRC) score	up to 90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decubitus ulcer	Appearance of decubitus ulcer during ICU stay	up to 90 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois

Publications and helpful links

General Publications

• Loss SH, Nunes DSL, Franzosi OS, Salazar GS, Teixeira C, Vieira SRR. Chronic critical illness: are we saving patients or creating victims? Rev Bras Ter Intensiva. 2017 Jan-Mar;29(1):87-95. doi: 10.5935/0103-507X.20170013.
• Viana MV, Pantet O, Bagnoud G, Martinez A, Favre E, Charriere M, Favre D, Eckert P, Berger MM. Metabolic and Nutritional Characteristics of Long-Stay Critically Ill Patients. J Clin Med. 2019 Jul 7;8(7):985. doi: 10.3390/jcm8070985.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): April 13, 2020
• Study Completion (Actual): April 13, 2020

Study Registration Dates

• First Submitted: April 27, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 13, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Metabolism, Energy,Glucose, Protein, Energy deficit
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: CER2018-02018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Coded (deidentified) database containing all nutritional, metabolic and laboratory variables

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No