Bio Impedance Electrical Analysis to Predict Outcome After Cardiac Surgery

Completed

• Conditions: Post Operative Care After Cardiac Surgery With Cardio Pulmonary Bypass
• Interventions: Diagnostic Test: Bioelectrical impedance analysis

• Registration Number: NCT05229159
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2021-10-31
• Study First Submitted: 2021-11-22
• Study Completion: 2021-11-30
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-27
• Last Update Submitted: 2022-01-27
• Study First Posted: 2022-02-08
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BiPOCS group	Bioelectrical impedance analysis	All patients of our centers admitted for postoperative care after cardiac surgery with cardiopulmonary bypass and receiving a bioelectrical impedance analysis at the admission.

Primary Outcome Measures

Name	Time	Method
Area under the receiver operating characteristic curve to predict a composite criterion including in-hospital mortality or prolonged hospital length of stay.	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"

Trial Locations

Locations (1)

Hôpital cardiologique Louis Pradel Groupe Hospitalier Est; 🇫🇷 Bron, Rhône, France