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

Sponsor
Medical Centre Leeuwarden (Other)
Overall Status
Completed
CT.gov ID
NCT04449796
Collaborator
(none)
1,025
Enrollment
1
Location
24
Actual Duration (Months)
42.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1025 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Predictive Value of Bio-impedance Vector Analysis on Long-term Outcome in ICU Patients
    Actual Study Start Date :
    Jun 1, 2018
    Actual Primary Completion Date :
    Jun 1, 2019
    Actual Study Completion Date :
    Jun 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 3 months survival [3 months]

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

    2. 6 months survival [6 months]

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

    3. 12 months survival [12 months]

      100% minus all-cause mortalityat twelve month post ICU

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Centre Leeuwarden - Intensive Care Unit Leeuwarden Netherlands 8901 BR

    Sponsors and Collaborators

    • Medical Centre Leeuwarden

    Investigators

    • Principal Investigator: E.C. Boerma, MD PhD, Medical Centre Leeuwarden

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical Centre Leeuwarden
    ClinicalTrials.gov Identifier:
    NCT04449796
    Other Study ID Numbers:
    • nWMO 2018-312
    First Posted:
    Jun 29, 2020
    Last Update Posted:
    Jul 9, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 9, 2020