Hôpital cardiologique Louis Pradel Groupe Hospitalier Est
Bron, Rhône, 69500, France
Completed
NCT Number: NCT05229159
Bio Impedance Electrical Analysis to Predict Outcome After Cardiac Surgery
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Bioelectrical Impedance Analysis
Diagnostic TestSegmental 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).
Primary outcomes
-
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"
Sponsors and collaborators
Lead sponsor
Hospices Civils de Lyon
Other
Registry information
Acronym: BiPOCS
Important dates
- Study start
- 2021
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Feb 8, 2022
- Registry last updated
- Feb 8, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.