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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03938961
Other study ID # CER2018-02018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2017
Est. completion date April 13, 2020

Study information

Verified date April 2020
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 205
Est. completion date April 13, 2020
Est. primary completion date April 13, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Adult ICU and Burns, University of Lausanne Hospital Lausanne Vaud

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. Review. Portuguese, English. — View Citation

Viana MV, Pantet O, Bagnoud G, Martinez A, Favre E, Charrière 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). pii: E985. doi: 10.3390/jcm8070985. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Decubitus ulcer Appearance of decubitus ulcer during ICU stay up to 90 days
Primary Vital Status Alive or dead at 90 days after ICU admission up to 90 days
Secondary Force Muscle strength measured by Medical research Council (MRC) score up to 90 days
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