Fluid vs Weight 24 Hour Balance (Bilance24)

March 11, 2026 updated by: Michal Kalina, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

55

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients admitted to intensive care unit in Masaryk Hospital in Ústí nad Labem Czech Republic.

Description

Inclusion criteria:

- adult (age ≥ 18 years) patients admitted to intensive care unit.

Exclusion criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICU patients
Adult patients admitted to a intensive care unit without any extracorporeal life organ support excluding artificial lung ventilation.
Other: Daily Weight and fluid balance change
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bilance24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Primary data will be stored at FZS UJEP data repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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