Cardiopulmonary DiseaseFLUBIACSNCT06498375
Fluid Status and Body Composition Analysis by Bioelectrical Impedance in Patients After Cardiac Surgery (FLUBIACS)
An observational study of Cardiopulmonary Disease and Fluid Overload, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Evaluation of fluid status in cardiac surgery patients using bioelectrical impedance and its impact on postoperative morbidity and mortality Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Disease, Fluid Overload
- What is being tested?
- Bioelectrical impedance
- How many people
- 150 participants
- Where
- 1 siteSlovenia
- Study dates
- Jul 2024to Jul 2026
- 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 (18 years or over) undergoing elective cardovascular surgery (on-pump or off-pump)
Who may be able to join
- Elective cardiovascular surgery (on-pump or off-pump)
- Age ≥ 18 years
- ASA 3 or 4
- Provided verbal and written informed consent
Who cannot join
- Refusal to participate in the research
- < 18 years
- Renal failure requiring replacement treatment with hemodialysis
- Amputation of a limb
- Pregnancy
- Emergency Procedures
- Reoperation
- Pacemaker/implantable cardioverter-defibrillator
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
Ljubljana
Tomislav Mirkovič, predstojnik.koait@kclj.si
About this study
Official title: Fluid Status and Body Composition Analysis in Patients After Cardiac Surgery Assessed by Bioelectrical Impedance Method and Its Impact on Postoperative Morbidity and Mortality
Evaluation of fluid status in cardiac surgery patients using bioelectrical impedance and its impact on postoperative morbidity and mortality
Read the detailed description
Hydration and fluid balance dynamics after cardiac surgery is complex and requires comprehensive knowledge of bluid balance dynamics. Surgical trauma, anaesthesia and use of cardiopulmonary bypass significantly influence postoperative fluid status. Deviations from normal values on the other hand can be related to increase in morbidity and mortality.
The purpose of this prospective observational clinical study is to assess fluid status using bioelectric impedance in patients undergoing cardiac surgery and to evaluate its impact on postoperative morbidity and mortality.
- Conditions
- Cardiopulmonary Disease, Fluid Overload
- Being tested
- Bioelectrical impedance
- Medical subject headings
- Pulmonary Heart Disease, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioelectrical impedanceDiagnostic test
Fluid distribution measured by bioelectrical impedance Bodystat Multiscan 5000 Bodystat Ltd, Isle of Man, British Isles
| Study group | Role | What they receive |
|---|---|---|
| On-pump cardiac surgery | Patients undergoing cardiac surgery with cardiopulmonary bypass Receives: Diagnostic Test: Bioelectrical impedance | |
| Off-pump cardiac surgery | Patients undergoing cardiac surgery without cardiopulmonary bypass Receives: Diagnostic Test: Bioelectrical impedance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid distribution during the early postoperative period (≤ 5 days)
Phase angle (in degrees)
Measured: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Fluid distribution during the early postoperative period (≤ 5 days)
Impedance ratio
Measured: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Fluid distribution during the early postoperative period (≤ 5 days)
Total body water (TBW), extracellular water (ECW), intracellular water (ICW) (in litres)
Measured: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Fluid distribution during the early postoperative period (≤ 5 days)
Oedema index (ECW/TBW ratio)
Measured: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Fluid distribution during the early postoperative period (≤ 5 days)
Body cell mass (in kilograms)
Measured: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Fluid distribution during the early postoperative period (≤ 5 days)
Skeletal muscle mass (in kilograms)
Measured: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Fluid distribution during the early postoperative period (≤ 5 days)
Bioelectrical impedance vector analysis
Measured: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Secondary outcomes (6)
Impact of fluid distribution/fluid overload on duration of postoperative mechanical ventilation
Measured: Duration of stay in ICU (estimated to up to 5 days)
Impact of fluid distribution/fluid overload on postoperative complications (myocardial infarction, cardiogenic shock, vasoplegia, atrial fibrillation, heart failure, bleeding, infections, delirium)
Measured: Up to 1 year after the operation
Impact of fluid distribution/fluid overload on length of stay in the intensive care unit
Measured: Duration of stay in ICU (estimated to up to 5 days)
Impact of fluid distribution/fluid overload on length of hospitalisation
Measured: Duration of hospital stay (up to 1 month)
Impact of fluid distribution/fluid overload on 30-day postoperative mortality
Measured: On day 30
Impact of fluid distribution/fluid overload on 1-year postoperative mortality
Measured: At 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary DiseaseStudies of the same condition, open and under way.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Kekec, University Medical Centre Ljubljana
- Investigators
- Gordana Taleska Štupica, MD, PhD, DESA, EDIC, Study chair, Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre LjubljanaLaura Kekec, MD, Principal investigator, Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre LjubljanaMatej Jenko, MD, Study director, Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre LjubljanaMaja Šoštarič, MD, PhD, Study director, Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498375
- Sponsor's protocol ID
- TP 20230216
- Acronym
- FLUBIACS
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Status and Body Composition Analysis in Patients After Cardiac Surgery Assessed by Bioelectrical Impedance Method and Its Impact on Postoperative Morbidity and Mortality
- ClinicalTrials.gov ID
- NCT06498375
- Acronym / sponsor ID
- FLUBIACS / TP 20230216
- Conditions
- Cardiopulmonary Disease, Fluid Overload
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 12 Jul 2024 (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.
Evaluation of fluid status in cardiac surgery patients using bioelectrical impedance and its impact on postoperative morbidity and mortality
Detailed description
Hydration and fluid balance dynamics after cardiac surgery is complex and requires comprehensive knowledge of bluid balance dynamics. Surgical trauma, anaesthesia and use of cardiopulmonary bypass significantly influence postoperative fluid status. Deviations from normal values on the other hand can be related to increase in morbidity and mortality.
The purpose of this prospective observational clinical study is to assess fluid status using bioelectric impedance in patients undergoing cardiac surgery and to evaluate its impact on postoperative morbidity and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On-pump cardiac surgery | – | Diagnostic Test: Bioelectrical impedancePatients undergoing cardiac surgery with cardiopulmonary bypass |
| Off-pump cardiac surgery | – | Diagnostic Test: Bioelectrical impedancePatients undergoing cardiac surgery without cardiopulmonary bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (18 years or over) undergoing elective cardovascular surgery (on-pump or off-pump)
Key inclusion criteria (4 listed)
- Elective cardiovascular surgery (on-pump or off-pump)
- Age ≥ 18 years
- ASA 3 or 4
- Provided verbal and written informed consent
Key exclusion criteria (8 listed)
- Refusal to participate in the research
- < 18 years
- Renal failure requiring replacement treatment with hemodialysis
- Amputation of a limb
- Pregnancy
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 impedanceFluid distribution measured by bioelectrical impedance Bodystat Multiscan 5000 Bodystat Ltd, Isle of Man, British Isles | Diagnostic test | Off-pump cardiac surgery, On-pump cardiac surgery |
Primary outcome
Fluid distribution during the early postoperative period (≤ 5 days)
Time frame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Phase angle (in degrees)
Fluid distribution during the early postoperative period (≤ 5 days)
Time frame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Impedance ratio
Fluid distribution during the early postoperative period (≤ 5 days)
Time frame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Total body water (TBW), extracellular water (ECW), intracellular water (ICW) (in litres)
Fluid distribution during the early postoperative period (≤ 5 days)
Time frame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Oedema index (ECW/TBW ratio)
Fluid distribution during the early postoperative period (≤ 5 days)
Time frame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Body cell mass (in kilograms)
Fluid distribution during the early postoperative period (≤ 5 days)
Time frame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Skeletal muscle mass (in kilograms)
Fluid distribution during the early postoperative period (≤ 5 days)
Time frame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Bioelectrical impedance vector analysis
6 secondary outcomes
Impact of fluid distribution/fluid overload on duration of postoperative mechanical ventilation
Time frame: Duration of stay in ICU (estimated to up to 5 days)
Impact of fluid distribution/fluid overload on postoperative complications (myocardial infarction, cardiogenic shock, vasoplegia, atrial fibrillation, heart failure, bleeding, infections, delirium)
Time frame: Up to 1 year after the operation
Impact of fluid distribution/fluid overload on length of stay in the intensive care unit
Time frame: Duration of stay in ICU (estimated to up to 5 days)
Impact of fluid distribution/fluid overload on length of hospitalisation
Time frame: Duration of hospital stay (up to 1 month)
Impact of fluid distribution/fluid overload on 30-day postoperative mortality
Time frame: On day 30
Impact of fluid distribution/fluid overload on 1-year postoperative mortality
Time frame: At 1 year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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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.
Gordana Taleska Štupica, MD, PhD, DESA, EDIC study chair
Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
Laura Kekec, MD principal investigator
Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
Matej Jenko, MD study director
Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
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 Cardiopulmonary Disease and Fluid Overload, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Jul 2024. 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 Slovenia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Kekec (+38640205330, laura.kekec@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid distribution during the early postoperative period (≤ 5 days) (time frame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)). The study lists 7 primary outcomes in all. 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 12 Jul 2024.