Fluid Balance and Body Weight Changes in Critically Ill Adult Patients

Critical Illness Clinical Trial

Official title:

Fluid Balance and Body Weight Changes in Critically Ill Adult Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04434079
• Other study ID #: 2018-0486
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: June 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Critical Illness
• Fluid Overload

Intervention

Other:
• Regular critical care
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.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between daily fluid balance (difference between fluid input and output during 24 hours) and the change on daily weight	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	Correlation between cumulative fluid balance and total weight change	Correlation between cumulative fluid balance and total weight change (Bland-Altman)	Last day of each patient's ICU hospitalization, up to 6 months
Secondary	Discriminative power of fluid balance in predicting ICU mortality	Area under ROC curve for fluid balance (L). ICU mortality as reference variable.	Through study completion, up to 6 months
Secondary	Discriminative power of body weight changes in predicting ICU mortality	Area under ROC curve for body weight change (kg). ICU mortality as reference variable.	Through study completion, up to 6 months