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.

Study Overview

• Status: Completed
• Conditions: Long-term Outcome; Survival

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 Type: Observational
• Enrollment (Actual): 1025

Contacts and Locations

Study Locations

• Netherlands
  • Leeuwarden, Netherlands, 8901 BR
    • Medical Centre Leeuwarden - Intensive Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

all patiens admitted to the ICU

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): June 1, 2019
• Study Completion (ACTUAL): June 1, 2020

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (ACTUAL): June 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: nWMO 2018-312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No