Bio Impedance Electrical Analysis to Predict Outcome After Cardiac Surgery (BiPOCS)

January 27, 2022 updated by: Hospices Civils de Lyon
Phase angle determined by bioelectrical impedance analysis is a strong prognostic factor in several medical areas as clinical nutrition, nephrology, infectious disease, oncology. Inflammation, frailty status and fluid overload can lead to a phase angle decreased. Some studies support its use for risk stratification in intensive care unit and other in preoperative for cardiac surgery. The investigators would like to evaluate its relevance for risk stratification at intensive care unit admission in the context of postoperative cardiac surgery with cardiopulmonary bypass.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Rhône
      • Bron, Rhône, France, 69500
        • Hôpital cardiologique Louis Pradel Groupe Hospitalier Est

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults patients admitted in intensive care unit for postoperative care after cardiac surgery with cardiopulmonary bypass.

Description

Inclusion Criteria:

  • Age higher than 18
  • Cardiac surgery with cardiopulmonary bypass
  • Bioelectrical impedance analysis the day of the admission in intensive care unit

Exclusion Criteria:

  • Left ventricular assist device
  • Limitations des thérapeutiques actives en place pour le patient
  • Patient opposition to the use of his health data
  • Invalid bioelectrical impedance analysis
  • Advanced directives to withhold or withdraw life-sustaining treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BiPOCS group
All patients of our centers admitted for postoperative care after cardiac surgery with cardiopulmonary bypass and receiving a bioelectrical impedance analysis at the admission.
Diagnostic test: Bioelectrical impedance analysis
Segmental multi-frequency bioelectrical impedance analysis are carried out at all patient admitted to our ICU for postoperative care after cardiac surgery with cardiopulmonary bypass. Our objective is to evaluate the relevance of phase angle to predict mortality or a prolonged hospital length of stay. Phase angle is evaluated at ICU admission and will be compared to well-known prognostic scores computed in preoperative (EuroSCORE II) and at day one after surgery (SOFA, CASUS and SAPS II).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the receiver operating characteristic curve to predict a composite criterion including in-hospital mortality or prolonged hospital length of stay.
Time Frame: at 6 months after the cardiac surgery

The phase angle's area under the receptor operative curve to predict a composite criteria evaluated at hospital discharge and combining:

  • In hospital mortality
  • Prolonged hospital length of stay, defined by an in hospital length of stay greater than the 75th percentile of length of stay in the study population"
at 6 months after the cardiac surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 456

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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