Bio Impedance Electrical Analysis to Predict Outcome After Cardiac Surgery

NCT05229159 | Completed

• 1 other identifier: 456
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Care After Cardiac Surgery With Cardio Pulmonary Bypass

Keywords

phase angle; cardiac surgery; cardiopulmonary bypass; risk stratification; outcomes

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (1)

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

Interventions

Bioelectrical impedance analysis DIAGNOSTIC_TEST

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).

BiPOCS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital cardiologique Louis Pradel Groupe Hospitalier Est

Bron, Rhône, 69500, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: February 8, 2022
• Study Start: July 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: November 30, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)