NCT03938961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2020

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

3.2 years

First QC Date

April 27, 2019

Last Update Submit

April 13, 2020

Conditions

Keywords

Metabolism, Energy,Glucose, Protein, Energy deficit

Outcome Measures

Primary Outcomes (1)

  • Vital Status

    Alive or dead at 90 days after ICU admission

    up to 90 days

Secondary Outcomes (1)

  • Force

    up to 90 days

Other Outcomes (1)

  • Decubitus ulcer

    up to 90 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Major burns
  • Brain injury
  • Severe neurological condition as primary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adult ICU and Burns, University of Lausanne Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related 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.

    PMID: 28444077BACKGROUND
  • 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.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 27, 2019

First Posted

May 6, 2019

Study Start

February 1, 2017

Primary Completion

April 13, 2020

Study Completion

April 13, 2020

Last Updated

April 14, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Coded (deidentified) database containing all nutritional, metabolic and laboratory variables

Locations