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Fluid Status and Body Composition Analysis by Bioelectrical Impedance in Patients After Cardiac Surgery (FLUBIACS)

ConditionsCardiopulmonary DiseaseFluid Overload
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Centre Ljubljana

About this trial

Evaluation of fluid status in cardiac surgery patients using bioelectrical impedance and its impact on postoperative morbidity and mortality

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elective cardiovascular surgery (on-pump or off-pump)

Age ≥ 18 years

ASA 3 or 4

Provided verbal and written informed consent

Disqualifiers

Refusal to participate in the research

< 18 years

Renal failure requiring replacement treatment with hemodialysis

Amputation of a limb

Trial population

Adults (18 years or over) undergoing elective cardovascular surgery (on-pump or off-pump)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Bioelectrical impedance

    Diagnostic test

    Fluid distribution measured by bioelectrical impedance Bodystat Multiscan 5000 Bodystat Ltd, Isle of Man, British Isles

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: On-pump cardiac surgery1 intervention
Group B: Off-pump cardiac surgery1 intervention

Trial outcomes

Primary outcomes

1

Fluid distribution during the early postoperative period (≤ 5 days)

Phase angle (in degrees)

Time frame
Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
2

Fluid distribution during the early postoperative period (≤ 5 days)

Impedance ratio

Time frame
Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
3

Fluid distribution during the early postoperative period (≤ 5 days)

Total body water (TBW), extracellular water (ECW), intracellular water (ICW) (in litres)

Time frame
Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
4

Fluid distribution during the early postoperative period (≤ 5 days)

Oedema index (ECW/TBW ratio)

Time frame
Perioperative period (preoperatively, on the first, third, and fifth postoperative day)

Secondary outcomes

1

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)
2

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
3

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)
4

Impact of fluid distribution/fluid overload on length of hospitalisation

Time frame
Duration of hospital stay (up to 1 month)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Centre Ljubljana

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: