NCT04449796

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,025

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

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

June 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
Last Updated

July 9, 2020

Status Verified

June 1, 2020

Enrollment Period

1 year

First QC Date

June 24, 2020

Last Update Submit

July 7, 2020

Conditions

Long-term OutcomeSurvival

Outcome Measures

Primary Outcomes (3)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all patiens admitted to the ICU

You may qualify if:

  • all patients admitted to the ICU, elective and acute.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Centre Leeuwarden - Intensive Care Unit

Leeuwarden, 8901 BR, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 35504168DERIVED

Study Officials

  • E.C. Boerma, MD PhD

    Frisius Medisch Centrum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2020

First Posted

June 29, 2020

Study Start

June 1, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2020

Last Updated

July 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)