Fluid Balance and Body Weight Changes in Critically Ill Adult Patients

Completed

• Conditions: Critical Illness; Fluid Overload
• Interventions: Other: Regular critical care

• Registration Number: NCT04434079
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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.

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 Timeline

• Study Start: 2018-06-01
• Primary Completion: 2018-10-01
• Study Completion: 2018-12-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-12
• Last Update Submitted: 2020-06-12
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Included individuals	Regular critical care	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.

Primary Outcome Measures

Name	Time	Method
Correlation between daily fluid balance (difference between fluid input and output during 24 hours) and the change on daily weight	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil