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

Survival Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04449796
• Other study ID #: nWMO 2018-312
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2020
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1025
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Long-term Outcome
• Survival

Locations

Country	Name	City	State
Netherlands	Medical Centre Leeuwarden - Intensive Care Unit	Leeuwarden

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 months survival	100% minus all-cause mortality at three month post ICU	3 months
Primary	6 months survival	100% minus all-cause mortality at six month post ICU	6 months
Primary	12 months survival	100% minus all-cause mortalityat twelve month post ICU	12 months