Weight BiasBilance24NCT07474116
Fluid vs Weight 24 Hour Balance
An observational study of Weight Bias and Weight Change, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s..
Trial summary
Daily Fluid Balance vs Weight Change Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Bias, Weight Change, Fluid Balance
- What is being tested?
- Daily Weight and fluid balance change
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Sep 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to intensive care unit in Masaryk Hospital in Ústí nad Labem Czech Republic.
Who may be able to join
- adult (age ≥ 18 years) patients admitted to intensive care unit.
Who cannot join
- age <18 years
- pregnancy
- inability to obtain standardized daily body weight using the ICU bed scale
- incomplete 24-hour fluid balance data preventing calculation of cumulative balance
- absence of an indwelling urinary catheter, extracorporeal life support (ECMO) or other extracorporeal circulation
- open abdomen
Show all 12Show fewer
- open chest
- lavage or irrigation procedures during the assessment interval
- surgery during the assessment
- massive bleeding
- diarrhoea during the assessment period
- massive transfusion protocol during the 24-hour interval and ICU stay shorter than 24 hours.
About this study
Official title: More Than a Number: Why Daily Fluid Balance Alone Should Not Guide Clinical Decision-Making in the ICU: A Prospective Observational Study
Daily Fluid Balance vs Weight Change
Read the detailed description
The daily fluid balance will be compared to 24hour weight change in critical care patients. The design will be prospective observational study. The data will be gathered using Linet automatic built in weight in Linet beds and for fluid balance will be used standard nurse charting method. The main outcome will be limit of agreement between daily fluid change and 24hour weight change.
- Conditions
- Weight Bias, Weight Change, Fluid Balance, Fluid Accumulation
- Being tested
- Daily Weight and fluid balance change
- Keywords
- fluid balance, weight change, fluid accumulation, fluid deresuscitation
- Medical subject headings
- Weight Prejudice, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Weight and fluid balance changeOther
In all enrolled patients, both 24-hour body weight change and cumulative 24-hour net fluid balance will be assessed over identical 24-hour intervals by nursing personnel. Fluid balance will be recorded using a standardized 24-hour fluid balance chart and calculated as the difference between total fluid intake and urine output and fluid output to drains. Body weight measurement will be performed once daily. Body weight will be measured using the integrated weighing system of the ICU bed.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | Adult patients admitted to a intensive care unit without any extracorporeal life organ support excluding artificial lung ventilation. Receives: Other: Daily Weight and fluid balance change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between 24hour fluid balance and daily weight change
The primary objective of the study is to assess the agreement between changes in body weight and cumulative 24-hour fluid balance over identical time intervals in ICU patients.
Measured: 24 hours from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight BiasStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Kalina, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474116
- Sponsor's protocol ID
- Bilance24
- Acronym
- Bilance24
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Primary data will be stored at FZS UJEP data repository.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- More Than a Number: Why Daily Fluid Balance Alone Should Not Guide Clinical Decision-Making in the ICU: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07474116
- Acronym / sponsor ID
- Bilance24 / Bilance24
- Conditions
- Weight Bias, Weight Change, Fluid Balance, Fluid Accumulation
- Keywords
- fluid balance, weight change, fluid accumulation, fluid deresuscitation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.University, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 16 Mar 2026 (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.
Daily Fluid Balance vs Weight Change
Detailed description
The daily fluid balance will be compared to 24hour weight change in critical care patients. The design will be prospective observational study. The data will be gathered using Linet automatic built in weight in Linet beds and for fluid balance will be used standard nurse charting method. The main outcome will be limit of agreement between daily fluid change and 24hour weight change.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | Other: Daily Weight and fluid balance changeAdult patients admitted to a intensive care unit without any extracorporeal life organ support excluding artificial lung ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to intensive care unit in Masaryk Hospital in Ústí nad Labem Czech Republic.
Key inclusion criteria (1 listed)
- adult (age ≥ 18 years) patients admitted to intensive care unit.
Key exclusion criteria (12 listed)
- age <18 years
- pregnancy
- inability to obtain standardized daily body weight using the ICU bed scale
- incomplete 24-hour fluid balance data preventing calculation of cumulative balance
- absence of an indwelling urinary catheter, extracorporeal life support (ECMO) or other extracorporeal circulation
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 |
|---|---|---|
| Daily Weight and fluid balance changeIn all enrolled patients, both 24-hour body weight change and cumulative 24-hour net fluid balance will be assessed over identical 24-hour intervals by nursing personnel. Fluid balance will be recorded using a standardized 24-hour fluid balance chart and calculated as the difference between total fluid intake and urine output and fluid output to drains. Body weight measurement will be performed once daily. Body weight will be measured using the integrated weighing system of the ICU bed. | Other | ICU patients |
Primary outcome
Agreement between 24hour fluid balance and daily weight change
Time frame: 24 hours from enrollment
The primary objective of the study is to assess the agreement between changes in body weight and cumulative 24-hour fluid balance over identical time intervals in ICU patients.
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 16 Mar 2026.
- Individual participant dataSharing planned: Yes. Primary data will be stored at FZS UJEP data repository.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Bias and Weight Change, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s..
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 1 inclusion and 12 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: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Agreement between 24hour fluid balance and daily weight change (time frame: 24 hours from enrollment). 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 16 Mar 2026.