Post Operative Care After Cardiac Surgery With Cardio Pulmonary BypassBiPOCSNCT05229159
Bio Impedance Electrical Analysis to Predict Outcome After Cardiac Surgery
An observational study of Post Operative Care After Cardiac Surgery With Cardio Pulmonary Bypass, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Care After Cardiac Surgery With Cardio Pulmonary Bypass
- What is being tested?
- Bioelectrical impedance analysis
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients admitted in intensive care unit for postoperative care after cardiac surgery with cardiopulmonary bypass.
Who may be able to join
- Age higher than 18
- Cardiac surgery with cardiopulmonary bypass
- Bioelectrical impedance analysis the day of the admission in intensive care unit
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital cardiologique Louis Pradel Groupe Hospitalier Est
Bron, Rhône, 69500
About this study
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.
- Being tested
- Bioelectrical impedance analysis
- Keywords
- phase angle, cardiac surgery, cardiopulmonary bypass, risk stratification, outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioelectrical impedance analysisDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Bioelectrical impedance analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: at 6 months after the cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Jul 2021
- Primary completion31 Oct 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Care After Cardiac Surgery With Cardio Pulmonary BypassStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229159
- Sponsor's protocol ID
- 456
- Acronym
- BiPOCS
- Status last verified
- Jan 2022
- First submitted
- 22 Nov 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio Impedance Electrical Analysis to Predict Outcome After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05229159
- Acronym / sponsor ID
- BiPOCS / 456
- Keywords
- phase angle, cardiac surgery, cardiopulmonary bypass, risk stratification, outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BiPOCS group | – | Diagnostic Test: Bioelectrical impedance analysisAll patients of our centers admitted for postoperative care after cardiac surgery with cardiopulmonary bypass and receiving a bioelectrical impedance analysis at the admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients admitted in intensive care unit for postoperative care after cardiac surgery with cardiopulmonary bypass.
Key inclusion criteria (3 listed)
- Age higher than 18
- Cardiac surgery with cardiopulmonary bypass
- Bioelectrical impedance analysis the day of the admission in intensive care unit
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioelectrical impedance analysisSegmental 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). | Diagnostic test | BiPOCS group |
Primary outcome
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"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Care After Cardiac Surgery With Cardio Pulmonary Bypass, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.