Fluid and Electrolyte ImbalanceBIA-FLUIDNCT07142083
BIA-Guided vs. Conventional Fluid Resuscitation in ICU Patients
A study testing Bioelectrical Impedance Analysis (BCM) and Conventional Fluid Management in people with Fluid and Electrolyte Imbalance and Anesthesia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
In this study aimed to compare bioelectrical impedance analysis (BIA)-guided fluid resuscitation with conventional fluid management strategies in patients admitted to the intensive care unit (ICU) following major surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fluid and Electrolyte Imbalance, Anesthesia
- What is being tested?
- Bioelectrical Impedance Analysis (BCM) and Conventional Fluid Management
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Undergoing major surgery under general anesthesia(Major surgery defined as: vascular clamping or organ ischemia, intraoperative blood loss >1000 mL, need for >10 mcg/min norepinephrine infusion, surgery duration >4 hours, or requirement for perioperative blood transfusion)
- Admission to the intensive care unit (CU) after surgery
- Informed consent obtained
Who cannot join
- Refusal to participate or failure to provide informed consent
- Undergoing laparoscopic or emergency surgery
- Severe major organ dysfunction:Acute kidney injury stage 2 or 3 (KDIGO 2012) • Acute or chronic liver failure (ALT >3x or Child A-C cirrhosis
- Conditions preventing accurate BIA measurement: • Limb amputation • Metallic cardiac or joint prostheses • Pacemakers or intracardiac stents
- Body mass index >35 kg/m or < 18 kg/m
- Contraindications to lactated Ringer's solution (e.g. hypercalcemia, increased intracranial pressure)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Bioelectrical Impedance Analysis-Guided Versus Conventional Fluid Resuscitation Strategies on 28-Day Mortality in Intensive Care Unit Patients After Major Surgery
In this study aimed to compare bioelectrical impedance analysis (BIA)-guided fluid resuscitation with conventional fluid management strategies in patients admitted to the intensive care unit (ICU) following major surgery. The primary objective is to evaluate whether BIA-guided fluid therapy reduces 28-day mortality by optimizing fluid balance and preventing volume-related complications. Secondary outcomes include cumulative fluid balance, ICU and hospital length of stay, duration of mechanical ventilation, and need for vasopressor or inotropic support. This study is expected to provide evidence for the clinical utility and applicability of BIA in guiding postoperative fluid therapy in critically ill patients.
Read the detailed description
Fluid resuscitation plays a critical role in the perioperative care of patients undergoing major surgery.
Traditionally, fluid therapy decisions in the intensive care unit (ICU) have relied on static clinical parameters, which may not always reflect the patient's actual volume status. Bioelectrical impedance analysis (BIA) offers a noninvasive and dynamic assessment of hydration status, enabling more precise fluid management tailored to individual needs. This prospective, randomized controlled study aims to compare BIA-guided fluid resuscitation with conventional fluid management strategies in postoperative ICU patients. A total of 80 adult patients who meet the inclusion criteria will be randomized into two groups. Group 1 will receive standard fluid therapy based on clinical evaluation, including heart rate, blood pressure, urine output, passive leg raising test, and vena cava ultrasound assessment. Group 2 will undergo BIA measurements at 0, 12, 24, and 48 hours post-ICU admission to guide fluid management according to hydration status (dehydrated, euvolemic, or hypervolemic). The primary outcome is 28-day all-cause mortality. Secondary outcomes include cumulative fluid balance, ICU and hospital length of stay, duration of mechanical ventilation, and need for vasopressors or inotropic agents. By evaluating clinical outcomes between the two approaches, this study seeks to determine whether BIA-guided fluid management offers a clinically meaningful advantage in postoperative critical care.
- Conditions
- Fluid and Electrolyte Imbalance, Anesthesia
- Being tested
- Bioelectrical Impedance Analysis (BCM), Conventional Fluid Management
- Keywords
- Bioelectrical impedance analysis, Intensive Care, Fluid Resuscitation, Postoperative Fluid Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioelectrical Impedance Analysis (BCM)Device
The Body Composition Monitor (BCM) device will be used to perform daily bioelectrical impedance measurements to guide fluid resuscitation in critically ill patients after major surgery. Measurements include extracellular water, intracellular water, total body water, and phase angle. The results will be used to tailor fluid therapy.
Conventional Fluid ManagementProcedure or surgery
Patients in this group will receive fluid therapy based on standard clinical parameters including blood pressure, heart rate, urine output, laboratory values, and physical examination. No bioelectrical impedance measurement will be performed.
| Study group | Role | What they receive |
|---|---|---|
| BIA-Guided Fluid Therapy | Experimental | Patients in this group will receive postoperative fluid therapy guided by bioelectrical impedance analysis (BIA) using the Body Composition Monitor (BCM) device. Daily fluid decisions will be based on measurements such as Extracellular water (ECW)/ Total body water (TBW) and phase angle. Receives: Device: Bioelectrical Impedance Analysis (BCM) |
| Conventional Fluid Therapy | Active comparator | Patients in this group will receive conventional fluid management based on routine clinical parameters, including vital signs, urine output, physical examination, and laboratory values. No bioelectrical impedance analysis will be performed in this group. Receives: Procedure: Conventional Fluid Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality
The number of participants in each group who die from any cause within 28 days after admission to the intensive care unit (ICU) following major surgery. The primary comparison will be between patients receiving bioelectrical impedance analysis (BIA)-guided fluid therapy and those receiving conventional fluid management.
Measured: postoperative 28 days
Secondary outcomes (5)
Cumulative fluid balance
Total fluid input minus total fluid output calculated cumulatively for each patient during ICU stay. Fluid balance will be recorded daily and evaluated within the first 48 hours after ICU admission.
Measured: First 48 hours after ICU admission
ICU length of stay
The number of days each patient remains in the intensive care unit after major surgery, from admission to discharge from the ICU.
Measured: The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 28 days
Hospital length of stay
The total number of days from the patient's admission to the hospital (including ICU and ward stay) until discharge or death.
Measured: Measured in days admitted in the hospital, an average of 28 days
Duration of mechanical ventilation
Total number of hours each patient remains on invasive mechanical ventilation during the first 48 hours of ICU follow-up.
Measured: First 48 hours after ICU admission
Requirement for inotropic support
The number of patients in each group requiring any inotropic or vasopressor therapy during the ICU stay. The type, dose, and duration of inotropic support will be recorded.
Measured: First 48 hours after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Oct 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fluid and Electrolyte ImbalanceStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A computer-generated block randomization list will be created using an online randomization tool by a researcher who is not involved in patient treatment or follow-up. Patients will be assigned to one of two groups (BIA-guided fluid management or conventional fluid therapy) based on sealed opaque envelopes prepared in advance according to the randomization sequence.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma ULGER, Ondokuz Mayıs University
- Investigators
- Fatma Ülger, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142083
- Sponsor's protocol ID
- BIA2024
- Acronym
- BIA-FLUID
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical restrictions and the absence of prior informed consent for data sharing. Additionally, the study does not include a data sharing provision in the approved protocol or institutional ethics approval.
Publications
Chung YJ, Kim EY. Usefulness of bioelectrical impedance analysis and ECW ratio as a guidance for fluid management in critically ill patients after operation. Sci Rep. 2021 Jun 9;11(1):12168. doi: 10.1038/s41598-021-91819-7.
PubMed 34108597Myatchin I, Abraham P, Malbrain MLNG. Bio-electrical impedance analysis in critically ill patients: are we ready for prime time? J Clin Monit Comput. 2020 Jun;34(3):401-410. doi: 10.1007/s10877-019-00439-0. Epub 2019 Dec 5. No abstract available.
PubMed 31808061Wang K, Sun SL, Wang XY, Chu CN, Duan ZH, Yang C, Liu BC, Ding WW, Li WQ, Li JS. Bioelectrical impedance analysis-guided fluid management promotes primary fascial closure after open abdomen: a randomized controlled trial. Mil Med Res. 2021 Jun 7;8(1):36. doi: 10.1186/s40779-021-00329-0.
PubMed 34099065Basso F, Berdin G, Virzi GM, Mason G, Piccinni P, Day S, Cruz DN, Wjewodzka M, Giuliani A, Brendolan A, Ronco C. Fluid management in the intensive care unit: bioelectrical impedance vector analysis as a tool to assess hydration status and optimal fluid balance in critically ill patients. Blood Purif. 2013;36(3-4):192-9. doi: 10.1159/000356366. Epub 2013 Dec 20.
PubMed 24496190
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Bioelectrical Impedance Analysis-Guided Versus Conventional Fluid Resuscitation Strategies on 28-Day Mortality in Intensive Care Unit Patients After Major Surgery
- ClinicalTrials.gov ID
- NCT07142083
- Acronym / sponsor ID
- BIA-FLUID / BIA2024
- Conditions
- Fluid and Electrolyte Imbalance, Anesthesia
- Keywords
- Bioelectrical impedance analysis, Intensive Care, Fluid Resuscitation, Postoperative Fluid Management
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 26 Aug 2025 (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.
In this study aimed to compare bioelectrical impedance analysis (BIA)-guided fluid resuscitation with conventional fluid management strategies in patients admitted to the intensive care unit (ICU) following major surgery. The primary objective is to evaluate whether BIA-guided fluid therapy reduces 28-day mortality by optimizing fluid balance and preventing volume-related complications. Secondary outcomes include cumulative fluid balance, ICU and hospital length of stay, duration of mechanical ventilation, and need for vasopressor or inotropic support. This study is expected to provide evidence for the clinical utility and applicability of BIA in guiding postoperative fluid therapy in critically ill patients.
Detailed description
Fluid resuscitation plays a critical role in the perioperative care of patients undergoing major surgery.
Traditionally, fluid therapy decisions in the intensive care unit (ICU) have relied on static clinical parameters, which may not always reflect the patient's actual volume status. Bioelectrical impedance analysis (BIA) offers a noninvasive and dynamic assessment of hydration status, enabling more precise fluid management tailored to individual needs. This prospective, randomized controlled study aims to compare BIA-guided fluid resuscitation with conventional fluid management strategies in postoperative ICU patients. A total of 80 adult patients who meet the inclusion criteria will be randomized into two groups. Group 1 will receive standard fluid therapy based on clinical evaluation, including heart rate, blood pressure, urine output, passive leg raising test, and vena cava ultrasound assessment. Group 2 will undergo BIA measurements at 0, 12, 24, and 48 hours post-ICU admission to guide fluid management according to hydration status (dehydrated, euvolemic, or hypervolemic). The primary outcome is 28-day all-cause mortality. Secondary outcomes include cumulative fluid balance, ICU and hospital length of stay, duration of mechanical ventilation, and need for vasopressors or inotropic agents. By evaluating clinical outcomes between the two approaches, this study seeks to determine whether BIA-guided fluid management offers a clinically meaningful advantage in postoperative critical care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A computer-generated block randomization list will be created using an online randomization tool by a researcher who is not involved in patient treatment or follow-up. Patients will be assigned to one of two groups (BIA-guided fluid management or conventional fluid therapy) based on sealed opaque envelopes prepared in advance according to the randomization sequence.
| Arm | Type | Receives |
|---|---|---|
| BIA-Guided Fluid Therapy | Experimental | Device: Bioelectrical Impedance Analysis (BCM)Patients in this group will receive postoperative fluid therapy guided by bioelectrical impedance analysis (BIA) using the Body Composition Monitor (BCM) device. Daily fluid decisions will be based on measurements such as Extracellular water (ECW)/ Total body water (TBW) and phase angle. |
| Conventional Fluid Therapy | Active comparator | Procedure: Conventional Fluid ManagementPatients in this group will receive conventional fluid management based on routine clinical parameters, including vital signs, urine output, physical examination, and laboratory values. No bioelectrical impedance analysis will be performed in this group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Undergoing major surgery under general anesthesia(Major surgery defined as: vascular clamping or organ ischemia, intraoperative blood loss >1000 mL, need for >10 mcg/min norepinephrine infusion, surgery duration >4 hours, or requirement for perioperative blood transfusion)
- Admission to the intensive care unit (CU) after surgery
- Informed consent obtained
Key exclusion criteria (6 listed)
- Refusal to participate or failure to provide informed consent
- Undergoing laparoscopic or emergency surgery
- Severe major organ dysfunction:Acute kidney injury stage 2 or 3 (KDIGO 2012) • Acute or chronic liver failure (ALT >3x or Child A-C cirrhosis
- Conditions preventing accurate BIA measurement: • Limb amputation • Metallic cardiac or joint prostheses • Pacemakers or intracardiac stents
- Body mass index >35 kg/m or < 18 kg/m
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 Analysis (BCM)The Body Composition Monitor (BCM) device will be used to perform daily bioelectrical impedance measurements to guide fluid resuscitation in critically ill patients after major surgery. Measurements include extracellular water, intracellular water, total body water, and phase angle. The results will be used to tailor fluid therapy. | Device | BIA-Guided Fluid Therapy |
| Conventional Fluid ManagementPatients in this group will receive fluid therapy based on standard clinical parameters including blood pressure, heart rate, urine output, laboratory values, and physical examination. No bioelectrical impedance measurement will be performed. | Procedure or surgery | Conventional Fluid Therapy |
Primary outcome
28-day all-cause mortality
Time frame: postoperative 28 days
The number of participants in each group who die from any cause within 28 days after admission to the intensive care unit (ICU) following major surgery. The primary comparison will be between patients receiving bioelectrical impedance analysis (BIA)-guided fluid therapy and those receiving conventional fluid management.
5 secondary outcomes
Cumulative fluid balance
Time frame: First 48 hours after ICU admission
ICU length of stay
Time frame: The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 28 days
Hospital length of stay
Time frame: Measured in days admitted in the hospital, an average of 28 days
Duration of mechanical ventilation
Time frame: First 48 hours after ICU admission
Requirement for inotropic support
Time frame: First 48 hours after ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 34108597Chung YJ, Kim EY. Usefulness of bioelectrical impedance analysis and ECW ratio as a guidance for fluid management in critically ill patients after operation. Sci Rep. 2021 Jun 9;11(1):12168. doi: 10.1038/s41598-021-91819-7.
- Background: PubMed 31808061Myatchin I, Abraham P, Malbrain MLNG. Bio-electrical impedance analysis in critically ill patients: are we ready for prime time? J Clin Monit Comput. 2020 Jun;34(3):401-410. doi: 10.1007/s10877-019-00439-0. Epub 2019 Dec 5. No abstract available.
- Background: PubMed 34099065Wang K, Sun SL, Wang XY, Chu CN, Duan ZH, Yang C, Liu BC, Ding WW, Li WQ, Li JS. Bioelectrical impedance analysis-guided fluid management promotes primary fascial closure after open abdomen: a randomized controlled trial. Mil Med Res. 2021 Jun 7;8(1):36. doi: 10.1186/s40779-021-00329-0.
- Background: PubMed 24496190Basso F, Berdin G, Virzi GM, Mason G, Piccinni P, Day S, Cruz DN, Wjewodzka M, Giuliani A, Brendolan A, Ronco C. Fluid management in the intensive care unit: bioelectrical impedance vector analysis as a tool to assess hydration status and optimal fluid balance in critically ill patients. Blood Purif. 2013;36(3-4):192-9. doi: 10.1159/000356366. Epub 2013 Dec 20.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical restrictions and the absence of prior informed consent for data sharing. Additionally, the study does not include a data sharing provision in the approved protocol or institutional ethics approval.
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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.
Fatma Ülger study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioelectrical Impedance Analysis (BCM) and Conventional Fluid Management in people with Fluid and Electrolyte Imbalance and Anesthesia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 6 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
28-day all-cause mortality (time frame: postoperative 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07142083, which also lists 4 linked publications.
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 22 Oct 2026.