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

Completed

• Conditions: Survival; Long-term Outcome

• Registration Number: NCT04449796
• Lead Sponsor: Medical Centre Leeuwarden

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

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 Timeline

• Study Start: 2018-06-01
• Primary Completion: 2019-06-01
• Status Verified: 2020-06
• Study Completion: 2020-06-01
• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-29
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1025

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Medical Centre Leeuwarden - Intensive Care Unit; 🇳🇱 Leeuwarden, Netherlands