Fluid and Electrolyte ImbalanceNCT05220709
Bio Impedance Monitoring as a Tool to Assess Fluid Status in the Pediatric Surgical Patient? (PedFluid Study)
A study testing bio impedance spectroscopy by means of the Body Composition Monitor (Name of the device is BCM from Fresenius Medical Care D GmbH) in people with Fluid and Electrolyte Imbalance and Body Weight Changes, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The baseline infusion rate during surgery for pediatric patients still is the 'Holliday and Segar' rule (also known as the 4/2/1 rule) The question arises if this rule is not outdated, since it was calculated based on the caloric need of the pediatric population, calculated for cow milk. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Fluid and Electrolyte Imbalance, Body Weight Changes, Children, Only
- What is being tested?
- bio impedance spectroscopy by means of the Body Composition Monitor (Name of the device is BCM from Fresenius Medical Care D GmbH)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Apr 2022to 31 Mar 2025
- Phase
- Interventional
- 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 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Scheduled for elective surgery or investigation under general anesthesia
- Day care or inpatient hospitalisation
Who cannot join
- If sedation is needed instead of general anesthesia
- Critically ill patients for urgent surgery
- Patients who cannot lie still for performing correct measurements on the bio impedance monitor
- No informed consent obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bio Impedance Monitoring as a Tool to Assess Fluid Status in the Pediatric Surgical Patient: Can we Measure a Fluid Shift
The baseline infusion rate during surgery for pediatric patients still is the 'Holliday and Segar' rule (also known as the 4/2/1 rule) The question arises if this rule is not outdated, since it was calculated based on the caloric need of the pediatric population, calculated for cow milk. The study tends to validate the use of bio impedance measurements for registering fluid shifts in the pediatric surgical patients.
Read the detailed description
The Body Composition Monitor (BCM, Fresenius Medical Care, Germany) is the first device that determines individual fluid status and body composition in an easy and objective way. The technology uses bioimpedance spectroscopy (BIS) to determine total body water (TBW) and extracellular water volume (ECW).It measures at 50 frequencies over a range from 5 to 1000 kHz to determine the electrical resistances of the total body water and the extracellular water. While high-frequency current passes through the total body water, low-frequency current cannot penetrate cell membranes and thus flows exclusively through the extracellular water.
To obtain the clinically relevant output parameters, two advanced physiological models are used in the BCM: a volume model, describing electrical conductance in a cell suspension enabling the total body water and extracellular water as well as the intracellular water (ICW) to be calculated, and a body composition model calculating the three principal body compartments overhydration, lean tissue and adipose tissue from ECW and TBW information.
The measurement is a non-invasive and accurate method that is easy to apply and results are obtained within just two minutes. It has been extensively used in patients with kidney disease receiving dialysis, both in adult and pediatric patients. However, bio impedance spectrometry has not yet been tested in the perioperative setting.
This is a single-center pilot study to evaluate if bio impedance measurement is a workable tool to determine fluid shifts in the pediatric population after a surgical procedure was performed under general anesthesia. Patients will be seen preoperatively by an anesthesiologist which is standard of care upon surgery under general anesthesia and eligibility will be evaluated. Informed consent will be asked and has to be signed by the accompanying parent or legal guardian. Where possible, care will be taken to inform the child itself about the content of the study and to get a written acknowledge. There are no other investigations necessary for this research. All patients on the day of surgery will be fasted as by the guidelines of the European Society of Anesthesia. For patients in daycare surgery, measurements with BCM will be performed preoperatively and postoperatively before ending the IV line on the ward. For inpatient hospitalisation, measurements by BCM will be performed preoperatively, postoperatively 6 hours after induction and postoperatively 24 h after induction.. Age, gender, height, weight and blood pressure are registered in the device before starting the measurement. If the quality calculated by BCM is < 60%, the measurement will be repeated again and only good quality measurements will be used.
Data are collected on chip cards by the BCM. Data can be transferred to a personal computer for further analysis with the Fluid Management Tool (FMT). Site requirements is the availability of a low electronic surrounding for correct measurement. After discharge of the hospital no further follow up assessments regarding this study are needed.
- Being tested
- bio impedance spectroscopy by means of the Body Composition Monitor (Name of the device is BCM from Fresenius Medical Care D GmbH)
- Keywords
- bio impedance spectroscopy
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bio impedance spectroscopy by means of the Body Composition Monitor (Name of the device is BCM from Fresenius Medical Care D GmbH)Diagnostic test
The Body Composition Monitor provides information about the hydration status by a bioimpedance spectroscopy measurement of the body composition from which the level of overhydration can be derived. Four electrodes are used per measurement. All subjects get electrodes attached, following the wrist-ankle approach, in a tetrapolar arrangement. Two electrodes are placed on the hand: one on the wrist, and the second on the dorsal side of the metacarpalia, close to the phalanges. The other two electrodes are placed on the foot: one on the ankle, and the second on the dorsal side of the metatarsals, close to the phalanges of the toes. Age, gender, height, weight and blood pressure are registered in the device before starting the measurement. If the quality calculated by BCM is < 60%, the measurement will be repeated again. Measurements are taken under supervision of a trained technician or nurse.
| Study group | Role | What they receive |
|---|---|---|
| Bio impedance spectroscopy in children scheduled for elective surgery under general anesthesia | Other | All subjects receive bio impedance monitor measurements pre operatively and post operatively. Receives: Diagnostic Test: bio impedance spectroscopy by means of the Body Composition Monitor (Name of the device is BCM from Fresenius Medical Care D GmbH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
total body water
sum of intracellular water and extracellular water, calculated in liter
Measured: measurements with BCM will be done pre-surgery
total body water
sum of intracellular water and extracellular water, calculated in liter
Measured: measurements with BCM will be done within 6 hours post-surgery for patients in day care
total body water
sum of intracellular water and extracellular water, calculated in liter
Measured: measurements with BCM will be done within 24 hours post-surgery for hospitalized patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start5 Apr 2022
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Why it stopped: difficult inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid and Electrolyte ImbalanceStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-centre pilot study to evaluate the feasibility of bio impedance measurements to determine fluid shifts in the pediatric population after a surgical procedure was performed.
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vera Saldien, University Hospital, Antwerp
- Investigators
- Vera Saldien, MD,PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220709
- Sponsor's protocol ID
- 2021-0576
- Other IDs
- 002090
- Status last verified
- Nov 2026
- First submitted
- 6 Dec 2021
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio Impedance Monitoring as a Tool to Assess Fluid Status in the Pediatric Surgical Patient: Can we Measure a Fluid Shift
- ClinicalTrials.gov ID
- NCT05220709
- Acronym / sponsor ID
- 2021-0576
- Keywords
- bio impedance spectroscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficult inclusion
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 2 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.
The baseline infusion rate during surgery for pediatric patients still is the 'Holliday and Segar' rule (also known as the 4/2/1 rule) The question arises if this rule is not outdated, since it was calculated based on the caloric need of the pediatric population, calculated for cow milk. The study tends to validate the use of bio impedance measurements for registering fluid shifts in the pediatric surgical patients.
Detailed description
The Body Composition Monitor (BCM, Fresenius Medical Care, Germany) is the first device that determines individual fluid status and body composition in an easy and objective way. The technology uses bioimpedance spectroscopy (BIS) to determine total body water (TBW) and extracellular water volume (ECW).It measures at 50 frequencies over a range from 5 to 1000 kHz to determine the electrical resistances of the total body water and the extracellular water. While high-frequency current passes through the total body water, low-frequency current cannot penetrate cell membranes and thus flows exclusively through the extracellular water.
To obtain the clinically relevant output parameters, two advanced physiological models are used in the BCM: a volume model, describing electrical conductance in a cell suspension enabling the total body water and extracellular water as well as the intracellular water (ICW) to be calculated, and a body composition model calculating the three principal body compartments overhydration, lean tissue and adipose tissue from ECW and TBW information.
The measurement is a non-invasive and accurate method that is easy to apply and results are obtained within just two minutes. It has been extensively used in patients with kidney disease receiving dialysis, both in adult and pediatric patients. However, bio impedance spectrometry has not yet been tested in the perioperative setting.
This is a single-center pilot study to evaluate if bio impedance measurement is a workable tool to determine fluid shifts in the pediatric population after a surgical procedure was performed under general anesthesia. Patients will be seen preoperatively by an anesthesiologist which is standard of care upon surgery under general anesthesia and eligibility will be evaluated. Informed consent will be asked and has to be signed by the accompanying parent or legal guardian. Where possible, care will be taken to inform the child itself about the content of the study and to get a written acknowledge. There are no other investigations necessary for this research. All patients on the day of surgery will be fasted as by the guidelines of the European Society of Anesthesia. For patients in daycare surgery, measurements with BCM will be performed preoperatively and postoperatively before ending the IV line on the ward. For inpatient hospitalisation, measurements by BCM will be performed preoperatively, postoperatively 6 hours after induction and postoperatively 24 h after induction.. Age, gender, height, weight and blood pressure are registered in the device before starting the measurement. If the quality calculated by BCM is < 60%, the measurement will be repeated again and only good quality measurements will be used.
Data are collected on chip cards by the BCM. Data can be transferred to a personal computer for further analysis with the Fluid Management Tool (FMT). Site requirements is the availability of a low electronic surrounding for correct measurement. After discharge of the hospital no further follow up assessments regarding this study are needed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-centre pilot study to evaluate the feasibility of bio impedance measurements to determine fluid shifts in the pediatric population after a surgical procedure was performed.
| Arm | Type | Receives |
|---|---|---|
| Bio impedance spectroscopy in children scheduled for elective surgery under general anesthesia | Other | Diagnostic Test: bio impedance spectroscopy by means of the Body Composition Monitor (Name of the device is BCM from Fresenius Medical Care D GmbH)All subjects receive bio impedance monitor measurements pre operatively and post operatively. |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Scheduled for elective surgery or investigation under general anesthesia
- Day care or inpatient hospitalisation
Key exclusion criteria (4 listed)
- If sedation is needed instead of general anesthesia
- Critically ill patients for urgent surgery
- Patients who cannot lie still for performing correct measurements on the bio impedance monitor
- No informed consent obtained
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 |
|---|---|---|
| bio impedance spectroscopy by means of the Body Composition Monitor (Name of the device is BCM from Fresenius Medical Care D GmbH)The Body Composition Monitor provides information about the hydration status by a bioimpedance spectroscopy measurement of the body composition from which the level of overhydration can be derived. Four electrodes are used per measurement. All subjects get electrodes attached, following the wrist-ankle approach, in a tetrapolar arrangement. Two electrodes are placed on the hand: one on the wrist, and the second on the dorsal side of the metacarpalia, close to the phalanges. The other two electrodes are placed on the foot: one on the ankle, and the second on the dorsal side of the metatarsals, close to the phalanges of the toes. Age, gender, height, weight and blood pressure are registered in the device before starting the measurement. If the quality calculated by BCM is < 60%, the measurement will be repeated again. Measurements are taken under supervision of a trained technician or nurse. | Diagnostic test | Bio impedance spectroscopy in children scheduled for elective surgery under general anesthesia |
Primary outcome
total body water
Time frame: measurements with BCM will be done pre-surgery
sum of intracellular water and extracellular water, calculated in liter
total body water
Time frame: measurements with BCM will be done within 6 hours post-surgery for patients in day care
sum of intracellular water and extracellular water, calculated in liter
total body water
Time frame: measurements with BCM will be done within 24 hours post-surgery for hospitalized patients
sum of intracellular water and extracellular water, calculated in liter
Results and safety
The study was stopped early (reason given: difficult inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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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.
Vera Saldien, MD,PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bio impedance spectroscopy by means of the Body Composition Monitor (Name of the device is BCM from Fresenius Medical Care D GmbH) in people with Fluid and Electrolyte Imbalance and Body Weight Changes, run by University Hospital, Antwerp at 1 site in Belgium.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 5 Nov 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 Belgium. 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 was stopped early (reason given: difficult inclusion). Results are not available in the source record.
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?
total body water (time frame: measurements with BCM will be done pre-surgery). The study lists 3 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 5 Nov 2026.