Fluid Balance and Body Weight Changes in Critically Ill Adult Patients

June 12, 2020 updated by: Hospital de Clinicas de Porto Alegre
Positive fluid status has been consistently associated with worse prognosis in critically ill adult patients.However, observational studies showed poor agreement between fluid balance and body weight changes. The objective of the study is to compare the measurements of FB and BW over time and to assess correlation with ICU mortality.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Positive fluid status has been consistently associated with worse prognosis in critically ill adult patients. Daily and cumulative fluid balance (FB) is a routine nursing activity in intensive care unit (ICU). In view of the potential for errors in the calculation of FB totals and the problem of accounting for insensible fluid losses, measurement of body weight (BW) changes is an alternative non-invasive method commonly used for estimating body fluid status. Its accuracy over FB assumes a one kilogram change in BW equates to a one liter gain or loss in body fluid volume. However, observational studies showed poor agreement between those measurements, particularly among individuals staying more than a week in ICU possibly due to muscle and fat loss as well as bone demineralization. The objective of the study is to compare the measurements of FB and BW over time and to assess correlation with ICU mortality.

Study Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • RS
      • Porto Alegre, RS, Brazil
        • Hospital de Clinicas de Porto Alegre

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All adult patients consecutively admitted to the ICU from June to October 2018 are eligible if expected length of ICU stay is superior to 24 hours and no oral nutritional is being offered.

Description

Inclusion Criteria:

  • Individuals aged >18 years-old admitted to ICU;
  • Expected length of ICU stay superior to 24 hours.

Exclusion Criteria:

  • Individuals receiving oral diet;
  • Actual body weight superior to 227kgs or 501lb.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Included individuals
Adult patients consecutively admitted to the ICU from June to October 2018 are eligible if expected length of stay is superior to 24 hours and no oral nutritional has been offered.
Clinical demographic data, daily and cumulative FB (input minus output) with and without insensible fluid losses, and daily and total BW changes are recorded, as well as survival outcome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between daily fluid balance (difference between fluid input and output during 24 hours) and the change on daily weight
Time Frame: At midnight every 24 hours up to patient's ICU discharge or up to 6 months, whichever comes first.
Correlation between daily fluid balance and weight change (Bland-Altman agreement test)
At midnight every 24 hours up to patient's ICU discharge or up to 6 months, whichever comes first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between cumulative fluid balance and total weight change
Time Frame: Last day of each patient's ICU hospitalization, up to 6 months
Correlation between cumulative fluid balance and total weight change (Bland-Altman)
Last day of each patient's ICU hospitalization, up to 6 months
Discriminative power of fluid balance in predicting ICU mortality
Time Frame: Through study completion, up to 6 months
Area under ROC curve for fluid balance (L). ICU mortality as reference variable.
Through study completion, up to 6 months
Discriminative power of body weight changes in predicting ICU mortality
Time Frame: Through study completion, up to 6 months
Area under ROC curve for body weight change (kg). ICU mortality as reference variable.
Through study completion, up to 6 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Ana Carolina P Antonio, MD, PhD, Hospital de Clinicas de Porto Alegre

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 (Actual)

June 1, 2018

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

June 5, 2020

First Submitted That Met QC Criteria

June 12, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Critical Illness

Clinical Trials on Regular critical care

3
Subscribe