Predictive Value of Bio-impedance Vector Analysis on Long... | NCT04449796

Studies
Predictive Value of Bio-impedance Vector Analysis on Long-term Outcome in ICU Patients

NCT04449796

Sponsor

Frisius Medisch Centrum

Status

Completed

Last Update Posted

Jul 9, 2020Actual

Enrollment

1,025Actual

Phase

Not provided

Conditions

Long-term Outcome
Survival

Interventions

Not provided

Countries

Netherlands

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

Jun 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

Jun 1, 2018Actual

Primary Completion Date

Jun 1, 2019Actual

Completion Date

Jun 1, 2020Actual

First Submitted Date

Jun 24, 2020

First Submission Date that Met QC Criteria

Jun 24, 2020

First Posted Date

Jun 29, 2020Actual

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

Jul 7, 2020

Last Update Posted Date

Jul 9, 2020Actual

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

Phase angle, derived from bioimpedance analysis (BIA), reflects tissue quality and quantity in which cell mass, membrane integrity and hydration state are represented. Phase angle, as a measure of body composition, changes with the physical condition of patients and is associated with survival in several disease states and during ICU admission. Aim of the study is to explore the predictive value of the phase angle for long term ICU outcome.

Detailed Description

A single-centre prospective observational cohort will be performed with consecutive patients, elective and non elective, admitted to the ICU between 1st June 2018 and 1st June 2019. Demographic data, APACHE III, comorbidity and phase angle are collected and the ICU- , hospital- and 6 months survival will be registered.

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

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,025Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3 months survival	100% minus all-cause mortality at three month post ICU	3 months
6 months survival	100% minus all-cause mortality at six month post ICU	6 months
12 months survival	100% minus all-cause mortalityat twelve month post ICU	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients admitted to the ICU, elective and acute.

Exclusion Criteria:

age below 18
Length of stay at ICU < 6 hours
All invalid bio-impedence analysis (BIA) measurements

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

all patiens admitted to the ICU

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
E.C. Boerma, MD PhD	Frisius Medisch Centrum	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Centre Leeuwarden - Intensive Care Unit		Leeuwarden		8901 BR	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35504168	Derived	Stellingwerf F, Beumeler LFE, Rijnhart-de Jong H, Boerma EC, Buter H. The predictive value of phase angle on long-term outcome after ICU admission. Clin Nutr. 2022 Jun;41(6):1256-1259. doi: 10.1016/j.clnu.2022.03.029. Epub 2022 Apr 6.