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OpenTrials
Completed

NCT Number: NCT04449796

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

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.

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Key information

Conditions

Long-term Outcome Survival

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Centre Leeuwarden - Intensive Care Unit

Leeuwarden, 8901 BR, Netherlands

About this study

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 survival.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 3 months survival

    Time frame: 3 months

    100% minus all-cause mortality at three month post ICU

  2. 6 months survival

    Time frame: 6 months

    100% minus all-cause mortality at six month post ICU

  3. 12 months survival

    Time frame: 12 months

    100% minus all-cause mortalityat twelve month post ICU

Sponsors and collaborators

Lead sponsor

Frisius Medisch Centrum

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 29, 2020
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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