Metabolic and Nutritional Characteristics of Long-stayer... | NCT03938961

Studies
Metabolic and Nutritional Characteristics of Long-stayer ICU Patients

NCT03938961

Sponsor

Centre Hospitalier Universitaire Vaudois

Status

Completed

Last Update Posted

Apr 14, 2020Actual

Enrollment

205Actual

Phase

Not provided

Conditions

Critically Ill

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2017Actual

Primary Completion Date

Apr 13, 2020Actual

Completion Date

Apr 13, 2020Actual

First Submitted Date

Apr 27, 2019

First Submission Date that Met QC Criteria

May 3, 2019

First Posted Date

May 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2020

Last Update Posted Date

Apr 14, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mette M Berger, Clinical Professor, Centre Hospitalier Universitaire VaudoisPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire VaudoisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

205Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Critically ill patients who required more than 2 weeks of ICU treatment, and who have entered the ICU's long stayer program

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Adult ICU and Burns, University of Lausanne Hospital		Lausanne	Canton of Vaud	1011	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28444077	Background	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.
31284633	Result	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.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms